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Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities (VOYAGER PAD)

  • Study Details
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Inclusion Criteria:

  • Age ≥50
  • Documented moderate to severe symptomatic lower extremity atherosclerotic peripheral artery disease
  • Technically successful peripheral revascularization distal to the external iliac artery for symptomatic PAD (Peripheral artery disease) within the last 10 days prior to randomization

Exclusion Criteria:

  • Patients undergoing revascularization for asymptomatic PAD or mild claudication without functional limitation of the index leg.
  • Patients undergoing revascularization of the index leg to treat an asymptomatic or minimally symptomatic restenosis of a bypass graft or target lesion restenosis.
  • Prior revascularization on the index leg within 10 days of the qualifying revascularization.
  • Planned dual antiplatelet therapy (DAPT) use for the qualifying revascularization procedure of clopidogrel in addition to Acetylic salicylic acid (ASA) for >6 months after the qualifying revascularization procedure; it is strongly recommended that any course of clopidogrel is kept to the minimum necessary in accordance with local standard of care and international practice guidelines (typically 30 days, or up to 60 days for some drug-coated products or devices) and is only allowed for up to 6 months for complex procedures or devices in the investigator's opinion that require longer use.
  • Planned use of any additional antiplatelet agent other than clopidogrel and ASA after the qualifying revascularization procedure.

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The Voyager PAD Trial - New Path for Post-revascularisation PAD Patients

Affiliations.

  • 1 University Heart Centre at University Medical Centre, Hamburg-Eppendorf, Hamburg, Germany. Electronic address: [email protected].
  • 2 University Heart Centre at University Medical Centre, Hamburg-Eppendorf, Hamburg, Germany.
  • PMID: 32307302
  • DOI: 10.1016/j.ejvs.2020.03.041

Publication types

  • Factor Xa Inhibitors / therapeutic use*
  • Peripheral Arterial Disease / drug therapy*
  • Peripheral Arterial Disease / surgery*
  • Randomized Controlled Trials as Topic
  • Rivaroxaban / therapeutic use*
  • Vascular Surgical Procedures
  • Factor Xa Inhibitors
  • Rivaroxaban

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VOYAGER PAD: Rivaroxaban Reduces Total Events Post Lower Extremity Revascularization

Acc news story.

In patients with peripheral artery disease (PAD) who underwent a lower extremity revascularization (LER), rivaroxaban on top of aspirin significantly reduced the total event burden, according to new results of the VOYAGER PAD trial presented May 16 during ACC.21 and simultaneously published in the Journal of the American College of Cardiology .

The primary results from VOYAGER PAD, presented during ACC.20/WCC, showed that rivaroxaban 2.5 mg twice daily plus aspirin vs. placebo plus aspirin reduced first events by about 15%, with a number needed to treat to prevent a first event of 39 at three years in the 6,564 study patients. The median age of patients was 67 years and 26% were women. At baseline, 40% were diabetic, 60% had hyperlipidemia, and about 32% had coronary artery disease.

In this prespecified analysis, Rupert M. Bauersachs, MD , et al., explored the number of first and total events in the study population along with the types of events including all limb and cardiovascular events, and the efficacy of rivaroxaban on first and total events.

Over a median of 28 months after LER, there were 4,714 total first and subsequent vascular events, including 1,614 primary endpoint events and 3.100 vascular events. Primary endpoint events included acute limb ischemia, major amputation of a vascular cause, nonfatal myocardial infarction, nonfatal ischemic stroke and cardiovascular death. Vascular events included peripheral revascularization and venous thromboembolic event.

The results showed that rivaroxaban reduced total primary events by 14% (95% confidence interval [CI], 0.75-0.98; p=0.02) and total vascular events by 14% (95% CI, 0.79-0.95; p=0.003). For every 100 study participants, an estimated 4.4 primary endpoint events and 12.5 vascular events were prevented with rivaroxaban over three years. Of note, 60% of second events occurred in patients who had a first peripheral revascularization.

The authors note the "benefits must be weighed against bleeding risk." TIMI major bleeding was increased by 43% with rivaroxaban (62 vs. 44 events with placebo) and "ISTH major bleeding, a more sensitive measure, was similar in relative terms (42% increase)" but with 140 vs. 100, respectively.

"The current analysis demonstrates several novel findings. First, PAD patients undergoing LER are at an extremely high risk for limb and cardiovascular events with a significantly greater burden when considering total rather than first events. Second, the most significant burden of risk is driven by vascular limb outcomes with recurrent peripheral revascularization being a particularly frequent event. Finally, the magnitude of absolute benefit of rivaroxaban 2.5 mg twice daily plus aspirin versus aspirin alone in this population is even greater when considering total vascular events," the authors conclude.

Clinical Topics: Vascular Medicine

Keywords: ACC Annual Scientific Session, ACC21, Aneurysm, Ischemia

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The Voyager PAD study: a game changer in medical treatment after endovascular recanalization on peripheral arterial disease?

  • Published: 20 May 2020
  • Volume 43 , pages 1587–1588, ( 2020 )

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  • Fabrizio Fanelli   ORCID: orcid.org/0000-0002-5273-0609 1  

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Bonaca MP, Bauersachs RM, Anand SS, et al. Rivaroxaban in peripheral artery disease after revascularization. N Engl J Med. 2020. https://doi.org/10.1056/NEJMoa2000052 .

Hess CN, Norgren L, Ansel GM, et al. A structured review of antithrombotic therapy in peripheral artery disease with a focus on revascularization: a TASC (InterSociety Consensus for the Management of Peripheral Artery Disease) Initiative. Circulation. 2017;135(25):2534–55.

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Gerhard-Herman MD, Gornik HL, Barrett C, et al. 2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017;135(12):e726–e779779.

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Hussain MA, Al-Omran M, Creager MA, et al. Antithrombotic therapy for peripheral artery disease: recent advances. J Am Coll Cardiol. 2018;71(21):2450–67.

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Belch JJ, Dormandy J, Biasi GM, et al. Results of the randomized, placebo-controlled clopidogrel and acetylsalicylic acid in bypass surgery for peripheral arterial disease (CASPAR) trial. J Vasc Surg. 2010;52:825–33.

Weitz JI, Harenberg J. New developments in anticoagulants: past, present and future. Thromb Haemost. 2017;117(7):1283–8.

Anand SS, Bosch J, Eikelboom JW, et al. Rivaroxaban with or without aspirin in patients with stable peripheral or carotid artery disease: an international, randomised, double-blind, placebo-controlled trial. Lancet. 2018;391:219–29.

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Fanelli, F. The Voyager PAD study: a game changer in medical treatment after endovascular recanalization on peripheral arterial disease?. Cardiovasc Intervent Radiol 43 , 1587–1588 (2020). https://doi.org/10.1007/s00270-020-02524-3

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DOI : https://doi.org/10.1007/s00270-020-02524-3

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Landmark Phase 3 VOYAGER PAD Study of XARELTO ® (rivaroxaban) Plus Aspirin Shows Significant Benefit in Patients with Symptomatic Peripheral Artery Disease (PAD) after Lower-Extremity Revascularization

Xarelto ® has the potential to be the first anticoagulant in 20 years [i] to show a benefit in these high-risk patients two major phase 3 trials have evaluated xarelto ® vascular dose plus aspirin in treating patients with atherosclerotic disease.

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RARITAN, NJ, March 28, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the VOYAGER PAD study met its primary efficacy and principal safety endpoints, demonstrating the XARELTO ® (rivaroxaban) vascular dose (2.5 mg twice daily) plus aspirin (100 mg once daily) was superior to aspirin alone in reducing the risk of major adverse limb and cardiovascular (CV) events by 15 percent in patients with symptomatic peripheral artery disease (PAD) after lower-extremity revascularization, with similar rates of TIMI [1] major bleeding. VOYAGER PAD is the only study to show a significant benefit using dual pathway inhibition, an anticoagulant plus aspirin, in this patient population. Findings from this global, randomized, double-blind, Phase 3 study were presented as a late-breaking presentation during the virtual American College of Cardiology’s 69 th Annual Scientific Session, together with the World Congress of Cardiology (ACC.20/WCC), and simultaneously published in The New England Journal of Medicine .

PAD is a common circulatory condition that occurs when narrowed blood vessels reduce blood flow to the limbs, most often the legs. PAD affects more than 200 million people globally, [i] including eight million in the U.S. [ii PAD is the leading cause of amputation [iii] and results in high rates of fatal and non-fatal CV events. Often starting as asymptomatic, PAD typically progresses to a more symptomatic, chronic form, with revascularization needed when symptoms become severe. Current PAD guidelines recommend antiplatelet therapy alone, such as aspirin or clopidogrel, to help prevent CV events [iv] , [v] following revascularization; however, no medicines are specifically indicated to prevent amputation or acute limb ischemia in these patients.

“While the COMPASS trial established the efficacy of rivaroxaban plus aspirin in stable patients with PAD and coronary artery disease (CAD), there were important unanswered questions on the optimal strategy for patients with symptomatic PAD after lower-extremity revascularization, including those without CAD. This is a particularly high-risk period for severe limb outcomes as well as bleeding,” said Marc P. Bonaca, M.D., Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado. “The VOYAGER PAD study shows us the potential clinical utility of rivaroxaban 2.5 mg twice daily plus aspirin in preventing the most critical thrombotic complications, adverse limb and cardiovascular outcomes, during the post-revascularization period when PAD patients are most vulnerable to these serious events.”

CLICK TO TWEET: Now available: New Phase 3 results show significant benefit of @JanssenUS medicine plus aspirin in patients with symptomatic #PAD after lower-extremity revascularization. Full press release here: http://bit.ly/3ddwFNr

The VOYAGER PAD results complement findings from the landmark Phase 3 COMPASS study , which also examined the dual pathway approach of XARELTO ® (2.5 mg twice daily) plus aspirin (100 mg once daily). COMPASS found XARELTO ® plus aspirin significantly reduced the risk of major CV and limb events in patients with chronic PAD and/or coronary artery disease (CAD) compared to aspirin alone.

“Our EXPLORER clinical research program continues to produce evidence of the critical role XARELTO ® plays in helping to shape clinical practice and transform cardiovascular care,” said James List, M.D., Ph.D., Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development, LLC. “Based on the findings from the COMPASS and VOYAGER PAD studies, we believe a dual pathway approach of XARELTO ® 2.5 mg twice daily dose plus aspirin can potentially change how PAD is managed. We look forward to discussing these data with the U.S. Food & Drug Administration (FDA).”

“Janssen continues to live up to our long-standing commitment of working tirelessly to bring transformational therapies to patients in need,” said Mathai Mammen, M.D., Ph.D., Global Head of Janssen Research & Development, LLC, Johnson & Johnson. “XARELTO ® has the potential to be the first anticoagulant in 20 years to show a benefit in patients with PAD after lower-extremity revascularization and is a strong example of that commitment.”

VOYAGER PAD Results For the primary efficacy endpoint, XARELTO ® plus aspirin significantly reduced the risk of major adverse limb and CV events compared to aspirin alone. Specifically, researchers observed that nearly one in five patients taking aspirin alone suffered a major adverse limb or CV event, but this risk was significantly reduced by 15 percent when XARELTO ® was added. The Kaplan-Meier (KM) estimates of the incidence at three years for XARELTO ® /aspirin compared to aspirin alone were 17.3% vs. 19.9%, respectively (Hazard Ratio [HR]=0.85; 95% confidence interval [CI], 0.76-0.96; p=0.009). The benefit of adding XARELTO ® to aspirin was apparent early, was consistent among major subgroups and continued to accrue over time.

The principal safety endpoint was met, with no significant increase in TIMI major bleeding in patients treated with XARELTO ® plus aspirin compared to aspirin alone. The KM estimates of the incidence at three years for XARELTO ® /aspirin compared to aspirin alone were 2.65% vs. 1.87%, respectively (HR=1.43; 95% CI, 0.97–2.10; p=0.07). Of note, there were numerically fewer intracranial bleeding events in the XARELTO ® /aspirin group (0.60% vs. 0.90%; HR=0.78; 95% CI, 0.38–1.61) and no increase in fatal bleeding (0.21% vs. 0.21%; HR=1.02; 95% CI, 0.33–3.15) across both groups.

About VOYAGER PAD The Phase 3 VOYAGER PAD study included 6,564 patients from 542 sites across 34 countries worldwide. Patients were randomized in a 1:1 ratio and received either XARELTO ® (2.5 mg twice daily) plus aspirin (100 mg once daily) (n=3,286) or aspirin alone (100 mg once daily) (n=3,278). Patients were stratified by revascularization procedure type (endovascular vs. surgical) and use of clopidogrel, which was administered at the treating physician’s discretion. Patients were followed for a median of 28 months.

The primary efficacy endpoint was a composite of major adverse limb and CV events, including acute limb ischemia, major amputation for vascular causes, heart attack (myocardial infarction), ischemic stroke, or death from CV causes. The principal safety endpoint was major bleeding according to the TIMI classification.

Eligible patients were at least 50 years old and had documented symptomatic lower extremity PAD. Patients were eligible after a successful revascularization for symptomatic PAD within the last 10 days. Approximately two-thirds were treated with an endovascular procedure (65%) and one-third treated surgically (35%). Patients were excluded if they were clinically unstable, at heightened bleeding risk, or needed prohibited concomitant medications, including long-term clopidogrel. The median age was 67 years and 26% were women. Common risk factors included diabetes, an estimated glomerular filtration rate less than 60 mL/min/1.73 m 2 (indicating mild-to-moderate kidney disease) and current smokers.

More on COMPASS COMPASS, the largest clinical study of XARELTO ® to date, enrolled a total of 27,395 patients with chronic CAD and/or PAD. Patients were randomized in a 1:1:1 ratio, with one group receiving XARELTO ® (2.5 mg twice daily) plus aspirin (100 mg once daily), another group receiving XARELTO ® 5 mg twice daily, and the final group receiving aspirin 100 mg once daily. COMPASS was stopped approximately one year ahead of schedule due to efficacy.

COMPASS met its primary efficacy endpoint, with XARELTO ® /aspirin shown to be superior to aspirin alone, reducing major CV events by 24%. This finding was driven by a robust 42% reduction in any stroke and 22% reduction in CV death. While the risk of major bleeding was significantly higher in patients taking XARELTO ® /aspirin compared to aspirin alone, there was no significant difference in fatal bleeds, intracranial bleeds, symptomatic bleeding into a critical organ, or bleeding into the surgical site requiring reoperation between the treatment groups.

WHAT IS XARELTO ® (rivaroxaban)?

XARELTO ® is a prescription medicine used to:

· reduce the risk of stroke and blood clots in people who have a medical condition called atrial fibrillation that is not caused by a heart valve problem. With atrial fibrillation, part of the heart does not beat the way it should. This can lead to the formation of blood clots, which can travel to the brain, causing a stroke, or to other parts of the body

· treat blood clots in the veins of your legs (deep vein thrombosis or DVT) or lungs (pulmonary embolism or PE)

· reduce the risk of blood clots happening again in people who continue to be at risk for DVT or PE after receiving treatment for blood clots for at least 6 months

· help prevent a blood clot in the legs and lungs of people who have just had hip or knee replacement surgery

· help prevent blood clots in certain people hospitalized for an acute illness and after discharge, who are at risk of getting blood clots because of the loss of or decreased ability to move around (mobility) and other risks for getting blood clots, and who do not have a high risk of bleeding

XARELTO ® is used with low dose aspirin to:

· reduce the risk of serious heart problems, heart attack and stroke in people with coronary artery disease (a condition where the blood supply to the heart is reduced or blocked) or peripheral artery disease (a condition where the blood flow to the legs is reduced)

It is not known if XARELTO ® is safe and effective in children.

IMPORTANT SAFETY INFORMATION

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT XARELTO ® ?

XARELTO ® may cause serious side effects, including:

· Increased risk of blood clots if you stop taking XARELTO ® . People with atrial fibrillation (an irregular heart beat) that is not caused by a heart valve problem (nonvalvular) are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body. XARELTO ® lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking XARELTO ® , you may have increased risk of forming a clot in your blood.

Do not stop taking XARELTO ® without talking to the doctor who prescribes it for you. Stopping XARELTO ® increases your risk of having a stroke. If you have to stop taking XARELTO ® , your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming.

· Increased risk of bleeding. XARELTO ® can cause bleeding which can be serious, and may lead to death. This is because XARELTO ® is a blood thinner medicine (anticoagulant) that lowers blood clotting. During treatment with XARELTO ® you are likely to bruise more easily, and it may take longer for bleeding to stop. You may be at higher risk of bleeding if you take XARELTO ® and have certain other medical problems.

You may have a higher risk of bleeding if you take XARELTO ® and take other medicines that increase your risk of bleeding, including:

o Aspirin or aspirin-containing products

o Long-term (chronic) use of non-steroidal anti-inflammatory drugs (NSAIDs)

o Warfarin sodium (Coumadin ® , Jantoven ® )

o Any medicine that contains heparin

o Clopidogrel (Plavix ® )

o Selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)

o Other medicines to prevent or treat blood clots

Tell your doctor if you take any of these medicines. Ask your doctor or pharmacist if you are not sure if your medicine is one listed above.

Call your doctor or get medical help right away if you develop any of these signs or symptoms of bleeding:

o Unexpected bleeding or bleeding that lasts a long time, such as:

§ Nosebleeds that happen often

§ Unusual bleeding from gums

§ Menstrual bleeding that is heavier than normal, or vaginal bleeding

o Bleeding that is severe or you cannot control

o Red, pink, or brown urine

o Bright red or black stools (looks like tar)

o Cough up blood or blood clots

o Vomit blood or your vomit looks like “coffee grounds”

o Headaches, feeling dizzy or weak

o Pain, swelling, or new drainage at wound sites

· Spinal or epidural blood clots (hematoma). People who take a blood thinner medicine (anticoagulant) like XARELTO ® , and have medicine injected into their spinal and epidural area, or have a spinal puncture, have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). Your risk of developing a spinal or epidural blood clot is higher if:

o A thin tube called an epidural catheter is placed in your back to give you certain medicine

o You take NSAIDs or a medicine to prevent blood from clotting

o You have a history of difficult or repeated epidural or spinal punctures

o You have a history of problems with your spine or have had surgery on your spine

If you take XARELTO ® and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots. Tell your doctor right away if you have back pain, tingling, numbness, muscle weakness (especially in your legs and feet), or loss of control of the bowels or bladder (incontinence).

XARELTO ® is not for use in people with artificial heart valves.

XARELTO ® is not for use in people with antiphospholipid syndrome (APS), especially with positive triple antibody testing.

Do not take XARELTO ® if you:

· Currently have certain types of abnormal bleeding. Talk to your doctor before taking XARELTO ® if you currently have unusual bleeding.

· Are allergic to rivaroxaban or any of the ingredients of XARELTO ® .

Before taking XARELTO ® , tell your doctor about all your medical conditions, including if you:

· Have ever had bleeding problems

· Have liver or kidney problems

· Have antiphospholipid syndrome (APS)

· Are pregnant or plan to become pregnant. It is not known if XARELTO ® will harm your unborn baby.

o Tell your doctor right away if you become pregnant during treatment with XARELTO ® . Taking XARELTO ® while you are pregnant may increase the risk of bleeding in you or in your unborn baby.

o If you take XARELTO ® during pregnancy, tell your doctor right away if you have any signs or symptoms of bleeding or blood loss. See “What is the most important information I should know about XARELTO ® ?” for signs and symptoms of bleeding.

· Are breastfeeding or plan to breastfeed. XARELTO ® may pass into your breast milk. Talk to your doctor about the best way to feed your baby during treatment with XARELTO ® .

Tell all of your doctors and dentists that you are taking XARELTO ® . They should talk to the doctor who prescribed XARELTO ® for you before you have any surgery, medical or dental procedure.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Some of your other medicines may affect the way XARELTO ® works, causing side effects. Certain medicines may increase your risk of bleeding. See “What is the most important information I should know about XARELTO ® ?”

HOW SHOULD I TAKE XARELTO ® ?

· Take XARELTO ® exactly as prescribed by your doctor.

· Do not change your dose or stop taking XARELTO ® unless your doctor tells you to. Your doctor may change your dose if needed.

· Your doctor will decide how long you should take XARELTO ® .

· XARELTO ® may need to be stopped for one or more days before any surgery or medical or dental procedure. Your doctor will tell you when to stop taking XARELTO ® and when to start taking XARELTO ® again after your surgery or procedure.

· If you need to stop taking XARELTO ® for any reason, talk to the doctor who prescribed XARELTO ® to you to find out when you should stop taking it. Do not stop taking XARELTO ® without first talking to the doctor who prescribes it to you.

· If you have difficulty swallowing XARELTO ® tablets whole, talk to your doctor about other ways to take XARELTO ® .

· Do not run out of XARELTO ® . Refill your prescription of XARELTO ® before you run out. When leaving the hospital following a hip or knee replacement, be sure that you will have XARELTO ® available to avoid missing any doses.

· If you take too much XARELTO ® , go to the nearest hospital emergency room or call your doctor right away.

If you take XARELTO ® for:

o Atrial Fibrillation that is not caused by a heart valve problem:

§ Take XARELTO ® 1 time a day with your evening meal.

§ If you miss a dose of XARELTO ® , take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time.

o Blood clots in the veins of your legs or lungs:

§ Take XARELTO ® 1 or 2 times a day as prescribed by your doctor.

§ For the 10-mg dose , XARELTO ® may be taken with or without food.

§ For the 15-mg and 20-mg doses , take XARELTO ® with food at the same time each day.

§ If you miss a dose:

Ø If you take the 15-mg dose of XARELTO ® 2 times a day (a total of 30 mg of XARELTO ® in 1 day): Take XARELTO ® as soon as you remember on the same day. You may take 2 doses at the same time to make up for the missed dose. Take your next dose at your regularly scheduled time.

Ø If you take XARELTO ® 1 time a day: Take XARELTO ® as soon as you remember on the same day. Take your next dose at your regularly scheduled time.

o Hip or knee replacement surgery:

§ Take XARELTO ® 1 time a day with or without food.

o Blood clots in people hospitalized for an acute illness:

§ Take XARELTO ® 1 time a day, with or without food, while you are in the hospital and after you are discharged as prescribed by your doctor.

o Reducing the risk of serious heart problems, heart attack and stroke in coronary artery disease or peripheral artery disease:

§ Take XARELTO ® 2.5 mg 2 times a day with or without food.

§ If you miss a dose of XARELTO ® , take your next dose at your regularly scheduled time.

§ Take aspirin 75 to 100 mg once daily as instructed by your doctor.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF XARELTO ® ?

XARELTO ® may cause serious side effects:

· See “What is the most important information I should know about XARELTO ® ?”

The most common side effect of XARELTO ® was bleeding.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Janssen Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7736).

Please read full Prescribing Information , including Boxed Warnings, and Medication Guide for XARELTO ® .

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About Janssen Cardiovascular & Metabolism

In Cardiovascular & Metabolism (CVM), we take on the most pervasive diseases that burden hundreds of millions of people and healthcare systems around the world. As part of this long-standing commitment and propelled by our successes in treating type 2 diabetes (T2D) and thrombosis, we advance highly differentiated therapies that prevent and treat life-threatening cardiovascular and metabolic diseases. Uncovering new therapies that can improve the quality of life for this large segment of the population is an important endeavor – one which Janssen CVM will continue to lead in the years to come. Our mission is global, local and personal. Together, we can reshape the future of cardiovascular and metabolic prevention and treatment. Please visit www.janssen.com/cardiovascular-and-metabolism .

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

Learn more at www.janssen.com . Follow us at www.twitter.com/JanssenUS . Janssen Research & Development, LLC, is one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding rivaroxaban. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov , www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

[1] Thrombolysis In Myocardial Infarction

[i] Fowkes FG, Rudan D, Rudan I, et al. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet 2013;382:1329-40. [ii] Centers for Disease Control and Prevention. Peripheral Arterial Disease Fact Sheet/Data & Statistics. Retrieved 20 March 2020 from https://www.cdc.gov/heartdisease/pad.htm . [iii] Norgren L, Hiatt WR, Dormandy JA, Hirsch, et al. The next 10 years in the management of peripheral artery disease: perspectives from the ‘PAD 2009’ Conference. European Journal of Vascular and Endovascular Surgery 2010;40(3):375-380. [iv] Aboyans V, Ricco JB, Bartelink MEL, et al. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries. Endorsed by: the European Stroke Organization (ESO), The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). Eur Heart J 2018;39:763-816. [v] Gerhard-Herman MD, Gornik HL, Barrett C et al. 2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation 2017;135:e726-e779.

Media contacts: Joy-Lee Pasqualoni Mobile: (917) 547-8078 [email protected]

Sarah Freeman Mobile: (215) 510-4758 [email protected]

Investor contacts: Johnson & Johnson Christopher DelOrefice Office: (732) 524-2955

Lesley Fishman Office: (732) 524-3922

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Rivaroxaban dans l’AOMI revascularisée: l’étude VOYAGER PAD.

Le facteur Xa a un rôle central dans la cascade de la coagulation. Son inhibition induit une diminution de la formation de thrombine et impacte la formation de fibrine et le fonctionnement des plaquettes. Ceci explique qu'une molécule anti-Xa, en l'occurrence le rivaroxaban, puisse avoir un effet additionnel bénéfique en association à un antiplaquettaire en prévention artérielle. Dans l'étude COMPASS PAD, les évènements cardiovasculaires ischémiques majeurs étaient diminués de 28% et les évènements vasculaires majeurs de membre inférieur (MI) de 46% avec l'association rivaroxaban (2.5 mg x 2 par jour) et acide acétylsalicylique (100 mg x 1 par jour) chez des patients ayant une artériopathie oblitérante des membres inférieurs (AOMI) stable sans revascularisation récente. Jusqu'alors, aucun bénéfice n'a été démontré en post-revascularisation pour le versant thrombotique avec les différents schémas thérapeutiques testés (antivitamines K (AVK), association AVK-antiplaquettaire, association d'antiplaquettaires). De plus,ces schémas thérapeutiques ont entrainé une majoration du risque hémorragique (études Dutch BOA, WAVE, CASPAR). A noter que l'incidence des ischémies aiguës, des amputations majeures et des évènements cardio-vasculaires fatals ou non est très élevée en cas d'AOMI au stade de revascularisation.

L'étude VOYAGER PAD est la première à tester et montrer l'efficacité de l'association rivaroxaban (2.5 mg x 2 par jour) et acide acétylsalicylique (100 mg x 1 par jour) en post-revascularisation en utilisant un critère primaire composite incluant ischémie aiguë et amputation majeure de membres inférieurs (première étude à prendre en compte ces items). L'effet bénéfique est apparu dès 3 mois et s'est poursuivi tout au long de l'étude. Ce schéma thérapeutique ne s'est pas accompagné d'une augmentation des hémorragies majeures selon le critère primaire de sécurité ni des hémorragies intracrâniennes ou fatales.

VOYAGER PAD est une étude prospective randomisée (ratio 1:1) en double aveugle versus placebo comparant l'efficacité de l'association rivaroxaban (2.5 mg x 2 par jour) et acide acétylsalicylique (100 mg x 1 par jour) à l'acide acétylsalicylique en monothérapie chez des patients-AOMI d'au moins 50 ans inclus au 10 ème jour d'une revascularisation sous inguinale fonctionnelle avec stratification selon le type de revascularisation réalisée (chirurgicale, endovasculaire ou hybride), et la prise concomitante de clopidogrel dans la strate revascularisation endovasculaire ou hybride. La randomisation a eu lieu d'août 2015 à janvier 2018 et était centralisée et informatisée (34 pays, 542 sites). L'inclusion était impossible en cas de statut clinique instable, de fort risque hémorragique ou de trouble trophique dépassant le niveau des orteils. L'utilisation du clopidogrel était tolérée pendant au maximum 6 mois après l'inclusion. Cette étude a été construite et mise en place par un groupe collaboratif  incluant le Centre de prévention du Colorado. Le nombre de sujets nécessaires (n=6 500) a été calculé en se basant sur une réduction de 20%  de l'estimation de l'incidence des évènements ischémiques tous territoires confondus (7.5%). Une analyse intermédiaire était prévue et a été réalisée. Les patients étaient vus en consultation à 1, 3, 6 mois puis tous les 6 mois. Tous les évènements ont été adjudiqués par un comité indépendant.

Le critère primaire d'efficacité était composite et évaluait l'incidence cumulée à 3 ans de : ischémie aiguë de membre inférieur, amputation majeure de cause vasculaire, infarctus du myocarde (IDM), accident vasculaire cérébral (AVC) ischémique, mortalité cardio-vasculaire. Ce critère primaire d'efficacité a été analysé en intention de traiter.  Le critère secondaire d'efficacité incluait les items du critère primaire, mais aussi revascularisation non prévue pour ischémie du membre ayant justifié l'inclusion, hospitalisation pour évènement thrombotique coronaire ou des MI, AVC de toute cause, mortalité globale. Ce critère secondaire d'efficacité a été analysé de deux façons (intention de traiter et méthode hiérarchique). Le critère principal de sécurité comptabilisait les hémorragies majeures selon la classification TIMI (Thrombolysis in Myocardial Infarction : hémorragie fatale, hémorragie intracranienne, baisse du taux d'hémoglogine > 5 g/dL ou de l'hématocrite > 15%). Le critère secondaire de sécurité comptabilisait les hémorragies majeures selon la classification ISTH (International Society of Thrombosis and Haemostasis : hémorragie fatale, hémorragie de localisation critique, baisse du taux d'hémoglogine > 2 g/dL, transfusion de > 2 unités de sang total ou de culots globulaires). Les 2 critères de sécurité ont été analysés parmi les patients ayant reçu au moins une dose du traitement.

Les principales caractéristiques des 6 364 patients inclus étaient : âge médian = 67 ans, proportion de femmes = 26%, index de pression systolique médian = 0.56, tabagisme actif = 35%, diabète = 40%, hypertension artérielle = 81%, débit de filtration glomérulaire < 60 ml/mn/1.73m 2 = 20%, statine = 80%, bloqueur du système rénine angiotensine = 63%, antécédent coronaire = 31%, antécédent d'IDM = 11%. L'AOMI était évoluée puisque 36% des patients avaient un antécédent de revascularisation des MI, 6% un antécédent d'amputation et 30 % un antécédent d'ischémie critique chronique. Un tiers des patients ont été traités par chirurgie conventionnelle (35%) et 2/3 par technique endovasculaire ou hybride (65%). Il faut noter que près d'un quart des patients étaient au stade d'ischémie critique chronique (23%). Le suivi médian était de 28 mois. Le taux de perdus de vue était de 0.09 % dans les 2 groupes.

Les principaux résultats sont résumés dans le tableau ci dessous. Le nombre d'évènements ischémiques majeurs (critère primaire incluant ischémie aiguë et amputation majeure de membre) était significativement moindre dans le groupe rivaroxaban. Il en était de même pour les critères secondaires d'efficacité à l'exception de la mortalité globale. Pour le versant tolérance, la différence n'était pas significative pour le critère primaire (risque hémorragique selon TIMI). En revanche, le risque hémorragique était significativement plus élevé dans le groupe rivaroxaban en se basant sur le critère secondaire de tolérance (risque hémorragique selon ISTH). Aucune différence n'a été mise en évidence pour les hémorragies intracrâniennes ou fatales.

ASA : acide acétylsalicylique, HR : hazard ratio, IC : intervalle de confiance, NS : non significatif.

Les auteurs estiment que pour 10 000 patients traités pendant 1 an, l'association rivaroxaban-acide acétylsalicylique a permis d'éviter 181 évènements ischémiques majeurs, en entrainant en parallèle la survenue de 29 hémorragies selon la classification TIMI.

            Plusieurs limites de cette étude peuvent être soulevées : taux plus élevé que prévu d'arrêt de prise du traitement alloué de façon identique dans les 2 groupes (a pu minorer l'efficacité mesurée du groupe rivaroxaban), participation de 2 laboratoires pharmaceutiques au design de l'étude, à la sélection des sites, à l'élaboration de l'article et au sponsoring (Bayer et Janssen Pharmaceuticals).Claire LE HELLO

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Rationale and Study Design of the VOYAGER PAD Trial

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EP: 1 . Role of NOACs in Venous Thromboembolism and COMPASS Trial

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EP: 2 . COMPASS Trial: Subgroup Analysis and Implications

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EP: 3 . Rationale and Study Design of the VOYAGER PAD Trial

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EP: 4 . Case 1: Antithrombotic Regimen in High-Risk Patient

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EP: 5 . Case 1: Choice of Therapy for Peripheral Artery Disease

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EP: 6 . Case 1: THEMIS Trial and Subgroup Analysis With Revascularization

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EP: 7 . Case 2: Triple Antiplatelet Therapy in Patients With Stents

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EP: 8 . Case 2: Combination of Device and Drug for Patients With Stents

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EP: 9 . Case 2: Relationship Between LDL and Major Adverse CV Events

Transcript:

Deepak Bhatt, MD, MPH: Marc Bonaca, I can turn back to you to tell us about the VOYAGER PAD trial. What was the purpose, the design and the main result?

Marc Bonaca, MD, MPH: Thank you, Deepak. When we talk about rivaroxaban, I believe it’s 1 of the largest cardiovascular development programs ever. When we talk about arterial vascular disease, it began with the ATLAS trial establishing the low dose and showing a mortality benefit, and that was in a specific acute coronary syndrome population. We heard from Manesh about translating that in the consistent benefits for mortality that were seen in stable or chronic vascular disease, CAD [coronary artery disease] or PAD [peripheral artery disease].

The VOYAGER PAD trial was designed to be complementary. It was not designed to overlap with the other trials, but it took components of both the ATLAS trial and the COMPASS trial, and it said, “What about patients who have peripheral artery disease who are in the acute setting of their illness?” This is when they become sick enough to need peripheral intervention or revascularization, either for severe limiting claudication or critical limb ischemia, of which there were a large number in the trial.

The question for the VOYAGER PAD trial, then, was different from the other trials with what the relevant primary end point for this population in this setting is. It was also noting that, unlike the COMPASS trial, which was enriched for polyvascular disease, patients in the clinic with symptomatic PAD, only about a third of them had symptomatic coronary disease. Although you did angiograms in all of them, of course they’d have atherosclerosis. It’s a distinct population.

The VOYAGER PAD trial asked what the benefit is of this dual-pathway strategy of low-dose rivaroxaban plus aspirin vs aspirin alone in patients with symptomatic PAD requiring revascularization. It was a pragmatic trial in that it allowed people who were getting endovascular revascularization, surgical revascularization, critical limb ischemia—the more modern term for that—or claudication to see clopidogrel in the background. It was a distinguishing feature from the COMPASS trial, although it was also allowed in the ATLAS trial. That was the general design. I can go into some of the results, Deepak, if you’d like.

Deepak Bhatt, MD, MPH: Yes, that would be useful if you could share the main results.

Marc Bonaca, MD, MPH: One thing that caught my attention is this: Manesh mentioned that the background care was good in the COMPASS trial, but the event rates were high. That was particularly notable in this population. For the event rate in the placebo group, meaning they got aspirin, 80% got statins, about half of them got clopidogrel, and the event rate was about 20% at 3 years, which was extremely high. It shows the illness of this population. If you look at some of the subgroups like those with critical limb ischemia or prior revascularization, the event rates are almost 30% at 3 years, so they are at extremely high risk.

We then saw consistency with what we’ve seen for this dual-pathway approach in the other trials. We see that there’s an early separation of the curves with rivaroxaban and that the curves continue to diverge over time with a number needed to treat of less than 40 at 3 years. A lot of that benefit was apparent early on, so there was consistency in terms of a beneficial effect of the strategy in this very different population in different settings. What might get people’s attention is that the pattern of benefit looks a bit different from other populations. It’s driven by limb vascular outcomes, which are frequent in this population. That doesn’t mean that the trials are discordant at all because, if you look at the subgroups, for example polyvascular disease in the VOYAGER PAD trial, it looks just like the COMPASS trial in terms of the spectrum of benefit. What it tells us for this population in this setting is that the risk is driven by limb outcomes, and there was a remarkable benefit particularly for acute limb ischemia in this setting.

The other surprise was that Manesh said he had been surprised that the strategy was efficacious in the COMPASS trial. I wasn’t surprised knowing the results of ATLAS and COMPASS. What I was surprised about was the safety: This is a frail and fragile population with a lot of comorbidities, like renal dysfunction, and a lot of the patients were over 75 years old. I was worried, and a lot of people were worried in the procedural setting that the bleeding risk would be intolerable when in fact we observed no difference in take-back bleeding because patients were started after they achieved hemostasis. The risk for TIMI [thrombolysis in myocardial infarction] major bleeding and ISTH [International Society on Thrombosis and Haemostasis bleeding scale] major bleeding was around the scale of what we saw in the COMPASS trial, if not less, and there was no trend for intracranial hemorrhage or fatal bleeding. The notion that this is consistently efficacious but also safe, even when you give it on top of clopidogrel for a short period, was reassuring.

Deepak Bhatt, MD, MPH: That’s terrific. I want to stick with you, Marc, for 1 other thing that you presented, I believe at AHA [American Heart Association Scientific Sessions], and it had to do with the incidence and the cost of major atherothrombotic vascular events among patients who need lower-extremity revascularization. I thought it was an interesting and insightful analysis. It was out of the Optum database. It showed that there was a pretty high cost associated with these events, but do you want to quickly summarize what that work showed?

Marc Bonaca, MD, MPH: That’s a great question, Deepak. Beyond that, the morbidity and the cost in this population are extremely high, and they’re driven primarily by limb outcomes and by repeat revascularization. It turns out that acute limb ischemia is 1 of the most costly things that can occur in this population. When we applied the VOYAGER PAD trial strategy in concept to real-world prices, there was a cost savings of over $2000 per patient when treated with rivaroxaban because of the prevention, primarily of those limb events that are so costly.

Deepak Bhatt, MD, MPH: There were many things in there in which the cost range was up to $100,000 for lower-limb amputations, so there are a lot of health care costs generated by ischemic events. In general, everyone realizes stroke and the disability and costs associated with that, but amputation is a horrible thing beyond the morbidity as well as the health care cost implications.

Transcript Edited for Clarity

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A History of Moscow in 13 Dishes

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Travel Itinerary For One Week in Moscow: The Best of Moscow!

I just got back from one week in Moscow. And, as you might have already guessed, it was a mind-boggling experience. It was not my first trip to the Russian capital. But I hardly ever got enough time to explore this sprawling city. Visiting places for business rarely leaves enough time for sightseeing. I think that if you’ve got one week in Russia, you can also consider splitting your time between its largest cities (i.e. Saint Petersburg ) to get the most out of your trip. Seven days will let you see the majority of the main sights and go beyond just scratching the surface. In this post, I’m going to share with you my idea of the perfect travel itinerary for one week in Moscow.

Moscow is perhaps both the business and cultural hub of Russia. There is a lot more to see here than just the Kremlin and Saint Basil’s Cathedral. Centuries-old churches with onion-shaped domes dotted around the city are in stark contrast with newly completed impressive skyscrapers of Moscow City dominating the skyline. I spent a lot of time thinking about my Moscow itinerary before I left. And this city lived up to all of my expectations.

7-day Moscow itinerary

Travel Itinerary For One Week in Moscow

Day 1 – red square and the kremlin.

Metro Station: Okhotny Ryad on Red Line.

No trip to Moscow would be complete without seeing its main attraction. The Red Square is just a stone’s throw away from several metro stations. It is home to some of the most impressive architectural masterpieces in the city. The first thing you’ll probably notice after entering it and passing vendors selling weird fur hats is the fairytale-like looking Saint Basil’s Cathedral. It was built to commemorate one of the major victories of Ivan the Terrible. I once spent 20 minutes gazing at it, trying to find the perfect angle to snap it. It was easier said than done because of the hordes of locals and tourists.

As you continue strolling around Red Square, there’s no way you can miss Gum. It was widely known as the main department store during the Soviet Era. Now this large (yet historic) shopping mall is filled with expensive boutiques, pricey eateries, etc. During my trip to Moscow, I was on a tight budget. So I only took a retro-style stroll in Gum to get a rare glimpse of a place where Soviet leaders used to grocery shop and buy their stuff. In case you want some modern shopping experience, head to the Okhotny Ryad Shopping Center with stores like New Yorker, Zara, and Adidas.

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To continue this Moscow itinerary, next you may want to go inside the Kremlin walls. This is the center of Russian political power and the president’s official residence. If you’re planning to pay Kremlin a visit do your best to visit Ivan the Great Bell Tower as well. Go there as early as possible to avoid crowds and get an incredible bird’s-eye view. There are a couple of museums that are available during designated visiting hours. Make sure to book your ticket online and avoid lines.

Day 2 – Cathedral of Christ the Saviour, the Tretyakov Gallery, and the Arbat Street

Metro Station: Kropotkinskaya on Red Line

As soon as you start creating a Moscow itinerary for your second day, you’ll discover that there are plenty of metro stations that are much closer to certain sites. Depending on your route, take a closer look at the metro map to pick the closest.

The white marble walls of Christ the Saviour Cathedral are awe-inspiring. As you approach this tallest Orthodox Christian church, you may notice the bronze sculptures, magnificent arches, and cupolas that were created to commemorate Russia’s victory against Napoleon.

travel itinerary for one week in Moscow

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Unfortunately, the current Cathedral is a replica, since original was blown to bits in 1931 by the Soviet government. The new cathedral basically follows the original design, but they have added some new elements such as marble high reliefs.

Home to some precious collection of artworks, in Tretyakov Gallery you can find more than 150,000 of works spanning centuries of artistic endeavor. Originally a privately owned gallery, it now has become one of the largest museums in Russia. The Gallery is often considered essential to visit. But I have encountered a lot of locals who have never been there.

Famous for its souvenirs, musicians, and theaters, Arbat street is among the few in Moscow that were turned into pedestrian zones. Arbat street is usually very busy with tourists and locals alike. My local friend once called it the oldest street in Moscow dating back to 1493. It is a kilometer long walking street filled with fancy gift shops, small cozy restaurants, lots of cute cafes, and street artists. It is closed to any vehicular traffic, so you can easily stroll it with kids.

Day 3 – Moscow River Boat Ride, Poklonnaya Hill Victory Park, the Moscow City

Metro Station: Kievskaya and Park Pobedy on Dark Blue Line / Vystavochnaya on Light Blue Line

Voyaging along the Moscow River is definitely one of the best ways to catch a glimpse of the city and see the attractions from a bit different perspective. Depending on your Moscow itinerary, travel budget and the time of the year, there are various types of boats available. In the summer there is no shortage of boats, and you’ll be spoiled for choice.

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If you find yourself in Moscow during the winter months, I’d recommend going with Radisson boat cruise. These are often more expensive (yet comfy). They offer refreshments like tea, coffee, hot chocolate, and, of course, alcoholic drinks. Prices may vary but mostly depend on your food and drink selection. Find their main pier near the opulent Ukraine hotel . The hotel is one of the “Seven Sisters”, so if you’re into the charm of Stalinist architecture don’t miss a chance to stay there.

The area near Poklonnaya Hill has the closest relation to the country’s recent past. The memorial complex was completed in the mid-1990s to commemorate the Victory and WW2 casualties. Also known as the Great Patriotic War Museum, activities here include indoor attractions while the grounds around host an open-air museum with old tanks and other vehicles used on the battlefield.

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The hallmark of the memorial complex and the first thing you see as you exit metro is the statue of Nike mounted to its column. This is a very impressive Obelisk with a statue of Saint George slaying the dragon at its base.

Maybe not as impressive as Shanghai’s Oriental Pearl Tower , the skyscrapers of the Moscow City (otherwise known as Moscow International Business Center) are so drastically different from dull Soviet architecture. With 239 meters and 60 floors, the Empire Tower is the seventh highest building in the business district.

The observation deck occupies 56 floor from where you have some panoramic views of the city. I loved the view in the direction of Moscow State University and Luzhniki stadium as well to the other side with residential quarters. The entrance fee is pricey, but if you’re want to get a bird’s eye view, the skyscraper is one of the best places for doing just that.

Day 4 – VDNKh, Worker and Collective Farm Woman Monument, The Ostankino TV Tower

Metro Station: VDNKh on Orange Line

VDNKh is one of my favorite attractions in Moscow. The weird abbreviation actually stands for Russian vystavka dostizheniy narodnogo khozyaystva (Exhibition of Achievements of the National Economy). With more than 200 buildings and 30 pavilions on the grounds, VDNKh serves as an open-air museum. You can easily spend a full day here since the park occupies a very large area.

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First, there are pavilions that used to showcase different cultures the USSR was made of. Additionally, there is a number of shopping pavilions, as well as Moskvarium (an Oceanarium) that features a variety of marine species. VDNKh is a popular venue for events and fairs. There is always something going on, so I’d recommend checking their website if you want to see some particular exhibition.

A stone’s throw away from VDNKh there is a very distinctive 25-meters high monument. Originally built in 1937 for the world fair in Paris, the hulking figures of men and women holding a hammer and a sickle represent the Soviet idea of united workers and farmers. It doesn’t take much time to see the monument, but visiting it gives some idea of the Soviet Union’s grandiose aspirations.

I have a thing for tall buildings. So to continue my travel itinerary for one week in Moscow I decided to climb the fourth highest TV tower in the world. This iconic 540m tower is a fixture of the skyline. You can see it virtually from everywhere in Moscow, and this is where you can get the best panoramic views (yep, even better than Empire skyscraper).

top things to do in Moscow

Parts of the floor are made of tempered glass, so it can be quite scary to exit the elevator. But trust me, as you start observing buildings and cars below, you won’t want to leave. There is only a limited number of tickets per day, so you may want to book online. Insider tip: the first tour is cheaper, you can save up to $10 if go there early.

Day 5 – A Tour To Moscow Manor Houses

Metro Station: Kolomenskoye, Tsaritsyno on Dark Green Line / Kuskovo on Purple Line

I love visiting the manor houses and palaces in Moscow. These opulent buildings were generally built to house Russian aristocratic families and monarchs. Houses tend to be rather grand affairs with impressive architecture. And, depending on the whims of the owners, some form of a landscaped garden.

During the early part of the 20th century though, many of Russia’s aristocratic families (including the family of the last emperor) ended up being killed or moving abroad . Their manor houses were nationalized. Some time later (after the fall of the USSR) these were open to the public. It means that today a great many of Moscow’s finest manor houses and palaces are open for touring.

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There are 20 manor houses scattered throughout the city and more than 25 in the area around. But not all of them easily accessible and exploring them often takes a lot of time. I’d recommend focusing on three most popular estates in Moscow that are some 30-minute metro ride away from Kremlin.

Sandwiched between the Moscow River and the Andropov Avenue, Kolomenskoye is a UNESCO site that became a public park in the 1920’s. Once a former royal estate, now it is one of the most tranquil parks in the city with gorgeous views. The Ascension Church, The White Column, and the grounds are a truly grand place to visit.

You could easily spend a full day here, exploring a traditional Russian village (that is, in fact, a market), picnicking by the river, enjoying the Eastern Orthodox church architecture, hiking the grounds as well as and wandering the park and gardens with wildflower meadows, apple orchards, and birch and maple groves. The estate museum showcases Russian nature at its finest year-round.

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If my travel itinerary for one week in Moscow was a family tree, Tsaritsyno Park would probably be the crazy uncle that no-one talks about. It’s a large park in the south of the city of mind-boggling proportions, unbelievable in so many ways, and yet most travelers have never heard of it.

The palace was supposed to be a summer home for Empress Catherine the Great. But since the construction didn’t meet with her approval the palace was abandoned. Since the early 1990’s the palace, the pond, and the grounds have been undergoing renovations. The entire complex is now looking brighter and more elaborately decorated than at possibly any other time during its history. Like most parks in Moscow, you can visit Tsaritsyno free of charge, but there is a small fee if you want to visit the palace.

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Last, but by no means least on my Moscow itinerary is Kuskovo Park . This is definitely an off-the-beaten-path place. While it is not easily accessible, you will be rewarded with a lack of crowds. This 18th-century summer country house of the Sheremetev family was one of the first summer country estates of the Russian nobility. And when you visit you’ll quickly realize why locals love this park.

Like many other estates, Kuskovo has just been renovated. So there are lovely French formal garden, a grotto, and the Dutch house to explore. Make sure to plan your itinerary well because the estate is some way from a metro station.

Day 6 – Explore the Golden Ring

Creating the Moscow itinerary may keep you busy for days with the seemingly endless amount of things to do. Visiting the so-called Golden Ring is like stepping back in time. Golden Ring is a “theme route” devised by promotion-minded journalist and writer Yuri Bychkov.

Having started in Moscow the route will take you through a number of historical cities. It now includes Suzdal, Vladimir, Kostroma, Yaroslavl and Sergiev Posad. All these awe-inspiring towns have their own smaller kremlins and feature dramatic churches with onion-shaped domes, tranquil residential areas, and other architectural landmarks.

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I only visited two out of eight cities included on the route. It is a no-brainer that Sergiev Posad is the nearest and the easiest city to see on a day trip from Moscow. That being said, you can explore its main attractions in just one day. Located some 70 km north-east of the Russian capital, this tiny and overlooked town is home to Trinity Lavra of St. Sergius, UNESCO Site.

things to do in Moscow in seven days

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Sergiev Posad is often described as being at the heart of Russian spiritual life. So it is uncommon to see the crowds of Russian pilgrims showing a deep reverence for their religion. If you’re traveling independently and using public transport, you can reach Sergiev Posad by bus (departs from VDNKh) or by suburban commuter train from Yaroslavskaya Railway Station (Bahnhof). It takes about one and a half hours to reach the town.

Trinity Lavra of St. Sergius is a great place to get a glimpse of filling and warming Russian lunch, specifically at the “ Gostevaya Izba ” restaurant. Try the duck breast, hearty potato and vegetables, and the awesome Napoleon cake.

Day 7 – Gorky Park, Izmailovo Kremlin, Patriarch’s Ponds

Metro Station: Park Kultury or Oktyabrskaya on Circle Line / Partizanskaya on Dark Blue Line / Pushkinskaya on Dark Green Line

Gorky Park is in the heart of Moscow. It offers many different types of outdoor activities, such as dancing, cycling, skateboarding, walking, jogging, and anything else you can do in a park. Named after Maxim Gorky, this sprawling and lovely park is where locals go on a picnic, relax and enjoy free yoga classes. It’s a popular place to bike around, and there is a Muzeon Art Park not far from here. A dynamic location with a younger vibe. There is also a pier, so you can take a cruise along the river too.

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The Kremlin in Izmailovo is by no means like the one you can find near the Red Square. Originally built for decorative purposes, it now features the Vernissage flea market and a number of frequent fairs, exhibitions, and conferences. Every weekend, there’s a giant flea market in Izmailovo, where dozens of stalls sell Soviet propaganda crap, Russian nesting dolls, vinyl records, jewelry and just about any object you can imagine. Go early in the morning if you want to beat the crowds.

All the Bulgakov’s fans should pay a visit to Patriarch’s Ponds (yup, that is plural). With a lovely small city park and the only one (!) pond in the middle, the location is where the opening scene of Bulgakov’s novel Master and Margarita was set. The novel is centered around a visit by Devil to the atheistic Soviet Union is considered by many critics to be one of the best novels of the 20th century. I spent great two hours strolling the nearby streets and having lunch in the hipster cafe.

Conclusion and Recommendations

To conclude, Moscow is a safe city to visit. I have never had a problem with getting around and most locals are really friendly once they know you’re a foreigner. Moscow has undergone some serious reconstruction over the last few years. So you can expect some places to be completely different. I hope my one week Moscow itinerary was helpful! If you have less time, say 4 days or 5 days, I would cut out day 6 and day 7. You could save the Golden Ring for a separate trip entirely as there’s lots to see!

What are your thoughts on this one week Moscow itinerary? Are you excited about your first time in the city? Let me know in the comments below!

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24 comments.

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Ann Snook-Moreau

Moscow looks so beautiful and historic! Thanks for including public transit information for those of us who don’t like to rent cars.

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MindTheTravel

Yup, that is me 🙂 Rarely rent + stick to the metro = Full wallet!

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Mariella Blago

Looks like you had loads of fun! Well done. Also great value post for travel lovers.

Thanks, Mariella!

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I have always wanted to go to Russia, especially Moscow. These sights look absolutely beautiful to see and there is so much history there!

Agree! Moscow is a thousand-year-old city and there is definitely something for everyone.

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Tara Pittman

Those are amazing buildings. Looks like a place that would be amazing to visit.

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Adriana Lopez

Never been to Moscow or Russia but my family has. Many great spots and a lot of culture. Your itinerary sounds fantastic and covers a lot despite it is only a short period of time.

What was their favourite thing about Russia?

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Gladys Parker

I know very little about Moscow or Russia for the\at matter. I do know I would have to see the Red Square and all of its exquisite architectural masterpieces. Also the CATHEDRAL OF CHRIST THE SAVIOUR. Thanks for shedding some light on visiting Moscow.

Thanks for swinging by! The Red Square is a great starting point, but there way too many places and things to discover aside from it!

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Ruthy @ Percolate Kitchen

You are making me so jealous!! I’ve always wanted to see Russia.

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Moscow is in my bucket list, I don’t know when I can visit there, your post is really useful. As a culture rich place we need to spend at least week.

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DANA GUTKOWSKI

Looks like you had a great trip! Thanks for all the great info! I’ve never been in to Russia, but this post makes me wanna go now!

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Wow this is amazing! Moscow is on my bucket list – such an amazing place to visit I can imagine! I can’t wait to go there one day!

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The building on the second picture looks familiar. I keep seeing that on TV.

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Reesa Lewandowski

What beautiful moments! I always wish I had the personality to travel more like this!

etude voyager pad

Perfect itinerary for spending a week in Moscow! So many places to visit and it looks like you had a wonderful time. I would love to climb that tower. The views I am sure must have been amazing!

I was lucky enough to see the skyline of Moscow from this TV Tower and it is definitely mind-blowing.

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Chelsea Pearl

Moscow is definitely up there on my travel bucket list. So much history and iconic architecture!

Thumbs up! 🙂

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Blair Villanueva

OMG I dream to visit Moscow someday! Hope the visa processing would be okay (and become more affordable) so I could pursue my dream trip!

Yup, visa processing is the major downside! Agree! Time and the money consuming process…

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Moscow Voyager

Moscow’s best free city tour

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I love Moscow – this charming metropolis, its people, its history and its unique cityscape. I would like to share my passion for this city with you. It is my job to show you the most exciting corners of this fascinating metropolis. That’s why, as a travel specialist and your private tour guide Moscow in Russia, I organize a guided free city tour Moscow – so that everyone, regardless of their budget, would be able to enjoy the insider’s view of Moscow.

You get to see what only Moscow residents know and what other tourist guides keep from you. I am a licensed travel specialist in Russia and would like you to enjoy all facets of the capital of the largest country in the world, without demanding any money from you. I’ll show you the city on my free Moscow walking tour for 1.5-hours on foot.

Everything you need to know:

  • My tours take place daily by arrangement, I am the only English-speaking licensed tourist guide Moscow, who offers a free city tour.
  • My 1.5-hour free tours Moscow do not cost you a cent, I also offer other great paid tours as well.
  • I am an experienced local, I make the tours informative, but at the same time relaxed and not off the plane.

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Free Tours Moscow – Daily

My free tours Moscow city starts on Slavonic Square (Kitay-Gorod Metro Station), passes the world-famous St. Basil’s Cathedral, which was built by Ivan the Terrible on the south side of Red Square in the 16th century and where the tsars were once crowned. Then it goes across the Red Square at the Lenin Mausoleum, the luxury department store GUM and with a view of the Kremlin towards the historical museum. Of course, you will also learn more about the stories that once happened behind the thick walls of the Kremlin – from the Tsars and Napoleon to Stalin. Then we continue through the idyllic Alexander Garden.

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An advance booking is required!

Practical information:

Time: by arrangement, daily Duration: 1.5 hours Price: Free Language: English

«First acquaintance with Moscow» – a 2.5-hour city tour in the center of Moscow

This Moscow city tour starts on the Theater Square, past Lubyanka Square and the KGB-building, then through Kitay Gorod district and Varvarka Street, past the world-famous St. Basil’s Cathedral. Then it goes across Zarjadje Park, over Red Square at the Lenin Mausoleum, the GUM-department store and towards the Historical Museum. We walk through the Alexander Garden.

Time: by arrangement, daily Duration: 2.5 hours Price: 17 $ Students and children: 6 $ Language: English

A 3.5-hour car/bus tour of Moscow.

This is the best tour of Moscow city as all the important sights are visited. I am your Moscow city guide who will walk you through the city explaining the charming history of the city. This tour begins with picking you up from the hotel. 3 breaks are offered for photographing.

First, we will visit the most famous riverside streets and bridges in the center of the city with the most beautiful views of the Kremlin and the Moskva River (e.g. the Kremlin embankment and the Great Stone Bridge).

The first photo break is made at the Cathedral of Christ the Savior. We then pass by the district with numerous museums, Prechistinka Street and the district with numerous medical areas.

We again stop at the Novodevichy Convent, which is a UNESCO World Heritage Site on the other bank of the Moskva River to click pictures.

Then we visit “Sparrow Hills” where you can enjoy a bird’s eye view of the city of Moscow from the observation deck. Then there are the skyscrapers of Moscow-City, the Kutuzov avenue, the New Arbat, Tverskaya Street, the world-famous Bolshoi Theater, the KGB building and Varvarka Street. Here there are ample spots to click pictures.

We then drive past the Kremlin again and finally reach Red Square. We take a short tour of Red Square and say goodbye in the Alexander Garden.

Time: by arrangement, daily Duration: 3.5 hours Price for a group: 170-200 $ (depending on the number of travelers) Language: English

Metro tour – daily

Palaces for ordinary people – that was what Stalin promised to the people when the construction of the Moscow Metro began between the World Wars. The communist dictator hadn’t promised too much. No other underground system in the world can boast such spectacular architecture – chandeliers, decorations, stucco, paintings on the walls – each station is individually designed. No wonder that Moscow residents love their metro. I will guide you through the bustle of one of the busiest subways in the world and show you the most beautiful stations Moscow city has.

Time: by arrangement, daily Duration: 2 hours Price: 21 $ Students and children: 17 $ Language: English Included in the price: Metro tickets / the guided tour

Tour of Communist Moscow – every day

After the Communist October Revolution in 1918, Moscow became the capital of the Soviet Empire and was the center of socialist orbit for more than 70 years. This left its mark on Moscow, even if the USSR disintegrated more than a quarter of a century ago. The city streets are full of remnants of the communist regime and the Cold War. This is a walking tour where I will show you the most exciting places in Soviet Moscow: from the notorious KGB headquarters, also known as Lubyanka to the Karl Marx Monument to small hidden remains from the time of hammer and sickle. You will also learn about Stalin’s Great Terror political campaign and the system of the GULAG and how the USSR, the communist Russian republic, became modern Russia.

Time: by arrangement, daily Duration: 2 hours Price: 21 $ Students and children: 17 $ Language: English Included in the price: the guided tour

Alternative Moscow Tour – daily

Explore the unseen Moscow with your Moscow private guide and discover a range of sights during this alternative walking tour.  Away from the main tourist spots (in the central district of Kitay-Gorod), just a short walk from Red Square and St. Basil’s Cathedral, you suddenly find yourself in one of the trendiest districts of Moscow. This place not only has trendy cafes and green squares, but here you can see the most beautiful spray works (according to Albrecht Dürer), hangout-places of the youth and hipsters, as well as learn what Moscow looked like in the 19th century. Here you will also learn exciting and even bloody stories about famous gangsters, eccentric business people and legends like the wandering preacher Rasputin, who is known in Russia either as the “holy devil” or the mad monk. To learn a little more about Moscow’s culture, this is the tour for you. On my alternative tour, you will get to know Moscow away from the tourist hotspots. This tour is of 2 hours duration and you will experience the following on the tour:

  • St. John’s Hill, a quiet oasis right in the center, where time has stopped as it did in pre-Communist times
  • Khokhlovka Art Center, where Russian hipsters and street artists hang out
  • Samoskvorechye District where you can see beautiful streets and hear stories from old Moscow
Time: by arrangement, daily Duration: 2 hours Price: 21 $ Students and children: 17 $ Language: English Included in the price: the guided tour / tram ticket

Kremlin tour – daily (closed on Thursday)

With its 20 towers and high walls, the Kremlin rises imposingly over Red Square. This world-famous fortress with its area of ​​28 hectares is home to over 800 years of Russian history. Described as the eighth wonder of the world, this historic fortress complex is the principal symbol of Russia that sits on the banks of the Moscow River. Today the Kremlin still harbors numerous secrets and has palaces and cathedrals, surrounded by Kremlin Wall. The current wall was constructed between the 15 th  and 16 th  centuries, but the original wall was made of wood around the year 1147. The Kremlin Wall became an important symbol of Moscow’s importance in the Russian Empire. This top tourist destination attracts millions of people every year and there are various sights to see. With my Kremlin tour, you will see the oldest square in the city in the heart of the Kremlin, the once largest cannon in the world and the scene of numerous dramas – from Ivan the Terrible and Napoleon to Stalin. You cannot miss this unique experience.

An advance booking and prepayment for tickets are required.

Time: by arrangement, daily (closed on Thursday) Duration: 2 hours Price on request Students and children: on request Language: English Included in the price: Kremlin tickets / the guided tour

Moscow pub crawl – Friday / Saturday

Experience the real nightlife of Moscow with my Moscow Pub Crawl and enjoy 4 pubs/bars plus 4 welcome shot drinks. Move from one bar to another and get to know travelers from around the world as well as the locals. Play fun adventure games and contests in addition to getting perks in the bars. Between the bars, move from one place to another on foot. The routes are organized as such that you will walk no more than 10 minutes between the bars. Visit the most exciting events, parties, concerts, and dance in the bars. Moscow Pub Crawl is a tour that you will never forget.

This tour runs every Friday and Saturday evening at 8 PM and you need to bring along your passport or an ID card, comfortable shoes, and wear smart casual clothes.

An advance booking and a small prepayment are required!

Time: by arrangement, daily Duration: 4 hours Price on request Language: English Included in the price: the guided tour, 4 shot drinks

1.5-hour boat trip on the Moskva River.

Taking a boat tour in Moscow on the Moskva River is a very pleasant experience. It allows you to know the city from a totally different perspective and admire the beautiful bridges. In this 1.5-hour river trip, you will sail past many beautiful sites in Moscow, so you can take the best photos to commemorate this day. The ship makes several stops on the way. The trip starts from the Ustinskiy Bridge near Sarjadje Park and ends at the Kiev train station.

On this Boat Trip, you can see sights such as: the former Imperial Education House, Sarjadje Park, the “flowing”, “floating” bridge, the most beautiful view of the Kremlin, the Great Stone Bridge, the legendary House on the Quay, the Christ the Savior Cathedral , the monument to Peter the Great on the ship, the central sports arena Luzhniki, the Sparrow Hills, 240 meters high Lomonosov University, the numerous architecturally spectacular skyscrapers of Moscow-City, the Novodevichy Convent, the building of the Ministry of Foreign Affairs etc.

Time: by arrangement, daily Duration: 1.5 hours Price on request Language: English

A military tour – riding on tanks in Stupino (Moscow region)

Russian Military is one of the largest military forces in the world formed in 1992. With my Military Tour experience what it likes to be in the Russian military, shooting guns, ride the Tank T-34 and various models of German tanks from the Second World War, as well as armored personnel carriers and vehicles. You will also shoot from the AK-47 and another combat weapon.

The tour will begin with your private tour guide Moscow in a Soviet army van accompanied with some tasty snacks and tea for a tasty start. Upon arriving, you will have to put on the army safety clothing and climb the Russian armored vehicles. The tour will take you on the noisy, smoky tank, driving through mud roads. All participants will get the chance to drive the tank which is coordinated by the Russian military.

Time: by arrangement, daily Price on request Language: English

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Alexander Popov

Welcome to Russia! My name is Alexander, I was born in Moscow and I'm a passionate tour guide. I want to share my passion for Russia and my hometown with you. On my website you will find useful information to make your individual trip to Russia as interesting as possible.

Gorky Park and Sparrow Hills: Green Lungs, place to relax and meet

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Cette étude est formelle : l'eau la plus bleue du monde se trouve sur cette plage européenne

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Une étude menée par l'agence CV Villas a élu la plage la plus bleue du monde, et elle se trouve en Albanie !

Trop bleu pour être vrai ? Pas pour la plage de Pasqyra, en Albanie , plus connue sous le nom de «Plage du Miroir». C'est elle qui trône tout en haut du classement des plages aux eaux les plus bleues du monde, réalisé par l'agence CV Villas, spécialisée dans la location de villas. Si elle tire son surnom (et sa renommée) de l'effet miroir créé par le reflet du soleil sur la surface de la mer, cette plage de l'extrémité sud du pays, en face de Corfou ( Grèce ), brille donc également par le bleu de ses eaux. Attention cependant : bien qu'elle soit éloignée d'autres attractions touristiques du pays et qu'elle ne compte qu'un seul restaurant et bar, elle attire tout de même les foules.

Toujours dans ce même classement, c'est la plage de Paralia Mpouka, au sud de la Grèce, qui arrive deuxième, suivie de près par celle de Kassiopi, plus au nord du pays. Et la France se hisse dans le top 5 des plages aux eaux les plus bleues, avec la plage de la Vernette, à La Seyne-sur-Mer dans le Var. La plage de Kaputas, située dans le sud-ouest de la Turquie , complète ce podium. D'après CV Villas, c'est la Grèce qui rafle le plus de positions dans son classement : sept des trente plages mentionnées s'y situent.

Dans le top 10 du classement, on trouve en effet plusieurs plages grecques, à savoir notamment celles de Voulisma, de Foki et d'Omprogialos, respectivement en sixième, septième et neuvième positions. Le Portugal, avec sa plage de Carvalho, se hisse à la huitième place. Et l' Espagne , avec la plage de Los Lances, complète ce classement. Les passionnés de baignade, de plongée avec tuba, ou de photos de vacances de rêve, savent donc où se rendre pour leurs prochaines vacances.

Une étude basée sur la nuance de bleu la plus bleue au monde

Dans le détail, le classement de l'agence CV Villas a analysé 200 plages à travers le monde, en s'appuyant sur des images Google Maps non filtrées. Elle a ensuite affiché le code couleur RVB (ou code rouge-bleu-vert, qui est une manière de représenter les couleurs en utilisant un mélange du rouge, du vert et du bleu et en leur attribuant des valeurs allant de 0 à 255 pour représenter leur intensité) de celles-ci.

Une fois ce processus terminé, CV Villas a comparé son résultat au code couleur de la nuance de bleu YInMn, découverte en 2009 – et qui était la première nouvelle nuance de bleu inorganique découverte depuis plus de 200 ans. D'après Travel+Leisure , cette nuance est « la nuance certifiée la plus bleue » au monde. La plage de Pasqyra est celle s'en approchant le plus – sa teinte étant à 12,4 points de celle d'YInMn.

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le 24/04/2024 à 11:51

Sur la photo, je la vois verte.

le 24/04/2024 à 07:25

Article tout à fait approprié pour lancer le tourisme de masse dans cette région pauvre.

le 24/04/2024 à 07:12

sachant que l'eau n'est pas bleue à la base peut etre faut il s'en méfier...

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etude voyager pad

IMAGES

  1. Visual Abstract

    etude voyager pad

  2. VOYAGER PAD Efficacy and Safety of Rivaroxaban in

    etude voyager pad

  3. VOYAGER-PAD

    etude voyager pad

  4. VOYAGER-PAD: Rivaroxabán en pacientes con enfermedad vascular

    etude voyager pad

  5. Étude VOYAGER-PAD : le rivaroxaban en ajout à l’acide acétylsalicylique

    etude voyager pad

  6. Total Ischemic Event Reduction With Rivaroxaban After Peripheral

    etude voyager pad

VIDEO

  1. Dérivabilité et étude des Fonctions Exercice 81 Page MAXI

  2. Voyager: Overview

  3. Voyager Reviewed! (by a pedant) S4E11: CONCERNING FLIGHT

  4. Voyager Freqbox Philtre LPG

  5. Центр Jaguar Land Rover Experience

  6. BEST SKETCHBOOK/JOURNAL YOU CAN FIND ON AMAZON [or anywhere]

COMMENTS

  1. Rivaroxaban in Peripheral Artery Disease after Revascularization

    cular or Surgical Limb Revascularization for PAD (peripheral artery disease) (VOYAGER PAD) was designed to test the hypothesis that rivaroxaban at 2.5 mg twice daily added to aspirin, as com-

  2. Rivaroxaban in Peripheral Artery Disease after Revascularization

    (Funded by Bayer and Janssen Pharmaceuticals; VOYAGER PAD ClinicalTrials.gov number, NCT02504216.) Quick Take. Rivaroxaban in Peripheral Artery Disease. 2m 2s.

  3. Rivaroxaban in Patients With Recent Peripheral Artery Revascularization

    The VOYAGER PAD trial confirmed the higher bleeding risk in this population; however, rivaroxaban markedly improved limb outcomes following peripheral revascularization across the eGFR spectrum. The VOYAGER PAD trial provides evidentiary support to interventionalists and vascular surgeons discussing the risks and benefits of adjunctive ...

  4. VOYAGER PAD contributes to medical therapy for peripheral artery

    VOYAGER PAD, recently published in the New England Journal of Medicine, is an event-driven, double-blind, randomized controlled trial that includes 6564 patients who were randomized to either rivaroxaban (2.5 mg twice daily) and aspirin (100 mg daily) or aspirin alone.

  5. Rivaroxaban and Aspirin in Peripheral Artery Disease Lower ...

    Background: The VOYAGER PAD trial (Vascular Outcomes Study of ASA Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for Peripheral Artery Disease) demonstrated superiority of rivaroxaban plus aspirin versus aspirin to reduce major cardiac and ischemic limb events after lower extremity revascularization. Clopidogrel is commonly used as a short-term adjunct to aspirin ...

  6. Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major

    Rationale and design for the Vascular Outcomes study of ASA along with rivaroxaban in endovascular or surgical limb revascularization for peripheral artery disease (VOYAGER PAD). Am Heart J. 2018 May;199:83-91. doi: 10.1016/j.ahj.2018.01.011.

  7. VOYAGER-PAD: Rivaroxaban Associated With Reduced Adverse Limb, CV

    Peripheral artery disease (PAD) patients who have undergone lower-extremity revascularization and take rivaroxaban plus aspirin may have a lower incidence of major adverse limb and cardiovascular events than patients who take aspirin alone, according to results of the VOYAGER-PAD trial presented March 28 at ACC.20/WCC during a Late-Breaking Clinical Trial session and simultaneously published ...

  8. The Voyager PAD Trial

    The Voyager PAD Trial - New Path for Post-revascularisation PAD Patients Eur J Vasc Endovasc Surg. 2020 May;59(5):699-700. doi: 10.1016/j.ejvs.2020.03.041. Epub 2020 Apr 16. Authors E Sebastian Debus 1 , Mark R Nehler 2 ; executive committee of the Voyager PAD trial 2 Affiliations 1 University Heart Centre at University Medical Centre, Hamburg ...

  9. VOYAGER: Clinical Trial

    TRIAL DESIGN ‡1,2. VOYAGER PAD (Vascular Outcomes Study of ASA Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD) was a phase 3, multicenter, randomized, placebo-controlled, double-blind, event-driven, international study designed to evaluate whether XARELTO ® 2.5 mg twice daily (BID) plus aspirin (ASA) 100 mg once daily is more effective than aspirin 100 mg ...

  10. VOYAGER PAD: Rivaroxaban Reduces Total Events Post Lower Extremity

    The primary results from VOYAGER PAD, presented during ACC.20/WCC, showed that rivaroxaban 2.5 mg twice daily plus aspirin vs. placebo plus aspirin reduced first events by about 15%, with a number needed to treat to prevent a first event of 39 at three years in the 6,564 study patients. The median age of patients was 67 years and 26% were women.

  11. The Voyager PAD Trial in a Surgical Perspective: A Debate

    In a recent editorial, Debus and Nehler commented on the Voyager PAD trial,1 which showed a clinical benefit of combined rivaroxaban 2 × 2.5 mg on top of aspirin 100 mg vs. aspirin 100 mg alone in patients after recent successful endovascular or open revascularisation for symptomatic peripheral arterial disease (PAD).2 While Voyager PAD is a landmark trial, with the unique combination of a ...

  12. The Voyager PAD study: a game changer in medical treatment ...

    The results from the Voyager PAD trial are impressive. The addition of Rivaroxaban at a dose of 2.5 mg twice a day to aspirin in patients who underwent revascularization for symptomatic PAD reduced the incidence of the composite outcome of acute limb ischemia, amputation for vascular causes, myocardial infarction, ischemic stroke, or cardiovascular death (hazard ratio 0.85, 95% CI 0.76-0.96 ...

  13. Revascularisation for Symptomatic Peripheral Artery Disease: External

    The VOYAGER PAD trial (ClinicalTrials.gov identifier: NCT02504216) was an international, multicentre phase III randomised controlled trial (RCT) designed to assess the efficacy and safety of 2.5 mg rivaroxaban twice daily added to background therapy of 100 mg aspirin once daily for the prevention of major atherothrombotic vascular events in ...

  14. Landmark Phase 3 VOYAGER PAD Study of XARELTO

    About VOYAGER PAD The Phase 3 VOYAGER PAD study included 6,564 patients from 542 sites across 34 countries worldwide. Patients were randomized in a 1:1 ratio and received either XARELTO ® (2.5 mg twice daily) plus aspirin (100 mg once daily) (n=3,286) or aspirin alone (100 mg once daily) (n=3,278). Patients were stratified by revascularization ...

  15. Revascularisation for Peripheral Artery Disease in France: Implications

    The VOYAGER-PAD trial demonstrated the interest in dual pathway inhibition (DPI) (low dose rivaroxaban plus aspirin) to reduce limb and cardiovascular events after revascularisation for peripheral artery disease (PAD), but its applicability in clinical practice has not yet been assessed. This study aimed to assess the number of patients revascularised in France for PAD and to estimate the ...

  16. Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease

    Rivaroxaban is a selective direct factor Xa inhibitor that is used to prevent and treat venous thromboembolism 4-6 and to prevent stroke or systemic embolism in atrial fibrillation. 7 Among ...

  17. The COMPASS Trial

    Introduction. Patients with chronic coronary syndromes or peripheral artery disease (PAD) remain at an increased risk of cardiovascular events over the long term. 1 The COMPASS trial (Cardiovascular Outcomes for People Using Anticoagulation Strategies) demonstrated that in patients with chronic coronary syndromes and/or PAD, the combination of ...

  18. Rivaroxaban dans l'AOMI revascularisée: l'étude VOYAGER PAD

    L'étude VOYAGER PAD est la première à tester et montrer l'efficacité de l'association rivaroxaban (2.5 mg x 2 par jour) et acide acétylsalicylique (100 mg x 1 par jour) en post-revascularisation en utilisant un critère primaire composite incluant ischémie aiguë et amputation majeure de membres inférieurs (première étude à prendre en ...

  19. Rationale and Study Design of the VOYAGER PAD Trial

    The VOYAGER PAD trial asked what the benefit is of this dual-pathway strategy of low-dose rivaroxaban plus aspirin vs aspirin alone in patients with symptomatic PAD requiring revascularization. It was a pragmatic trial in that it allowed people who were getting endovascular revascularization, surgical revascularization, critical limb ischemia ...

  20. Walking Tour: Central Moscow from the Arbat to the Kremlin

    This tour of Moscow's center takes you from one of Moscow's oldest streets to its newest park through both real and fictional history, hitting the Kremlin, some illustrious shopping centers, architectural curiosities, and some of the city's finest snacks. Start on the Arbat, Moscow's mile-long pedestrianized shopping and eating artery ...

  21. How do I get from Moscow airports to the city center?

    With the classic taxi into the city. Bus metro combination. First the good news - all three airports are easy to reach, both by taxi and by public transport such as train and bus. All three airports are connected to the Moscow city center by means of the so-called Aeroexpress. The Aeroexpress is certainly the most popular and the easiest way ...

  22. Travel Itinerary For One Week in Moscow

    Day 6 - Explore the Golden Ring. Creating the Moscow itinerary may keep you busy for days with the seemingly endless amount of things to do. Visiting the so-called Golden Ring is like stepping back in time. Golden Ring is a "theme route" devised by promotion-minded journalist and writer Yuri Bychkov.

  23. Moscow's best free city tour

    Free Tours Moscow - Daily. Practical information: «First acquaintance with Moscow» - a 2.5-hour city tour in the center of Moscow. Practical information: A 3.5-hour car/bus tour of Moscow. Practical information: Metro tour - daily. Practical information: Tour of Communist Moscow - every day.

  24. Cette étude est formelle : l'eau la plus bleue du monde se trouve sur

    Une étude menée par l'agence CV Villas a élu la plage la plus bleue du monde, et elle se trouve en Albanie ! ... Brooklyn est devenu le quartier à explorer lors d'un voyage dans la « Grosse ...