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Rivaroxaban with or without aspirin in patients with stable peripheral or carotid artery disease: an international, randomised, double-blind, placebo-controlled trial
SS. Anand, J. Bosch, JW. Eikelboom, SJ. Connolly, R. Diaz, P. Widimsky, V. Aboyans, M. Alings, AK. Kakkar, K. Keltai, AP. Maggioni, BS. Lewis, S. Störk, J. Zhu, P. Lopez-Jaramillo, M. O'Donnell, PJ. Commerford, D. Vinereanu, N. Pogosova, L....
Language English Country England, Great Britain
Document type Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
NLK
ProQuest Central
from 1992-01-04 to 3 months ago
Nursing & Allied Health Database (ProQuest)
from 1992-01-04 to 3 months ago
Health & Medicine (ProQuest)
from 1992-01-04 to 3 months ago
Family Health Database (ProQuest)
from 1992-01-04 to 3 months ago
Psychology Database (ProQuest)
from 1992-01-04 to 3 months ago
Health Management Database (ProQuest)
from 1992-01-04 to 3 months ago
Public Health Database (ProQuest)
from 1992-01-04 to 3 months ago
- MeSH
- Amputation, Surgical statistics & numerical data MeSH
- Aspirin administration & dosage adverse effects therapeutic use MeSH
- Stroke epidemiology etiology prevention & control MeSH
- Lower Extremity blood supply surgery MeSH
- Double-Blind Method MeSH
- Incidence MeSH
- Myocardial Infarction epidemiology etiology prevention & control MeSH
- Platelet Aggregation Inhibitors administration & dosage adverse effects therapeutic use MeSH
- Factor Xa Inhibitors administration & dosage adverse effects therapeutic use MeSH
- Cardiovascular Diseases mortality prevention & control MeSH
- Drug Therapy, Combination MeSH
- Hemorrhage chemically induced MeSH
- Middle Aged MeSH
- Humans MeSH
- Morbidity MeSH
- Carotid Artery Diseases complications drug therapy epidemiology MeSH
- Peripheral Arterial Disease complications drug therapy epidemiology MeSH
- Rivaroxaban administration & dosage adverse effects therapeutic use MeSH
- Drug Administration Schedule MeSH
- Aged MeSH
- Dose-Response Relationship, Drug MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
BACKGROUND: Patients with peripheral artery disease have an increased risk of cardiovascular morbidity and mortality. Antiplatelet agents are widely used to reduce these complications. METHODS: This was a multicentre, double-blind, randomised placebo-controlled trial for which patients were recruited at 602 hospitals, clinics, or community practices from 33 countries across six continents. Eligible patients had a history of peripheral artery disease of the lower extremities (previous peripheral bypass surgery or angioplasty, limb or foot amputation, intermittent claudication with objective evidence of peripheral artery disease), of the carotid arteries (previous carotid artery revascularisation or asymptomatic carotid artery stenosis of at least 50%), or coronary artery disease with an ankle-brachial index of less than 0·90. After a 30-day run-in period, patients were randomly assigned (1:1:1) to receive oral rivaroxaban (2·5 mg twice a day) plus aspirin (100 mg once a day), rivaroxaban twice a day (5 mg with aspirin placebo once a day), or to aspirin once a day (100 mg and rivaroxaban placebo twice a day). Randomisation was computer generated. Each treatment group was double dummy, and the patient, investigators, and central study staff were masked to treatment allocation. The primary outcome was cardiovascular death, myocardial infarction or stroke; the primary peripheral artery disease outcome was major adverse limb events including major amputation. This trial is registered with ClinicalTrials.gov, number NCT01776424, and is closed to new participants. FINDINGS: Between March 12, 2013, and May 10, 2016, we enrolled 7470 patients with peripheral artery disease from 558 centres. The combination of rivaroxaban plus aspirin compared with aspirin alone reduced the composite endpoint of cardiovascular death, myocardial infarction, or stroke (126 [5%] of 2492 vs 174 [7%] of 2504; hazard ratio [HR] 0·72, 95% CI 0·57-0·90, p=0·0047), and major adverse limb events including major amputation (32 [1%] vs 60 [2%]; HR 0·54 95% CI 0·35-0·82, p=0·0037). Rivaroxaban 5 mg twice a day compared with aspirin alone did not significantly reduce the composite endpoint (149 [6%] of 2474 vs 174 [7%] of 2504; HR 0·86, 95% CI 0·69-1·08, p=0·19), but reduced major adverse limb events including major amputation (40 [2%] vs 60 [2%]; HR 0·67, 95% CI 0·45-1·00, p=0·05). The median duration of treatment was 21 months. The use of the rivaroxaban plus aspirin combination increased major bleeding compared with the aspirin alone group (77 [3%] of 2492 vs 48 [2%] of 2504; HR 1·61, 95% CI 1·12-2·31, p=0·0089), which was mainly gastrointestinal. Similarly, major bleeding occurred in 79 (3%) of 2474 patients with rivaroxaban 5 mg, and in 48 (2%) of 2504 in the aspirin alone group (HR 1·68, 95% CI 1·17-2·40; p=0·0043). INTERPRETATION: Low-dose rivaroxaban taken twice a day plus aspirin once a day reduced major adverse cardiovascular and limb events when compared with aspirin alone. Although major bleeding was increased, fatal or critical organ bleeding was not. This combination therapy represents an important advance in the management of patients with peripheral artery disease. Rivaroxaban alone did not significantly reduce major adverse cardiovascular events compared with asprin alone, but reduced major adverse limb events and increased major bleeding. FUNDING: Bayer AG.
3rd Department of Internal Medicine Semmelweis University Budapest Hungary
Amphia Ziekenhuis and Werkgroep Cardiologische centra Nederland Utrecht Netherlands
ANMCO Research Center Florence Italy
Brigham and Women's Hospital Heart and Vascular Center Harvard Medical School Boston MA USA
Centre for Cardiovascular Science University of Edinburgh Edinburgh UK
Comprehensive Heart Failure Center University Hospital at University of Würzburg Würzburg Germany
Dante Pazzanese Institute of Cardiology and University Santo Amaro São Paulo Brazil
Department of Cardiovascular Sciences University of Leuven Leuven Belgium
Department of Epidemiology and Preventive Medicine Monash University Melbourne VIC Australia
Department of Medicine K2 Karolinska Institute Stockholm Sweden
Department of Medicine McMaster University Hamilton ON Canada
Department of Medicine University of Washington Seattle WA USA
Dupuytren University Hospital Limoges France
Estudios Clínicos Latino America and Instituto Cardiovascular de Rosario Rosario Argentina
National Research Centre for Preventative Medicine Moscow Russia
National University of Ireland Galway Ireland
Research Institute FOSCAL Bucaramanga Bucaramanga Colombia
School of Rehabilitation Sciences McMaster University Hamilton ON Canada
Thrombosis Research Institute and University College London London UK
University of Cape Town Cape Town South Africa
University of Medicine and Pharmacy Carol Davila University and Emergency Hospital Bucharest Romania
References provided by Crossref.org
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