AIMS: To describe outcomes of patients with chronic coronary artery disease (CAD) and/or peripheral artery disease (PAD) enrolled in the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) randomized trial who were treated with the combination of rivaroxaban 2.5 mg twice daily and aspirin 100 mg once daily during long-term open-label extension (LTOLE). METHODS AND RESULTS: Of the 27 395 patients enrolled in COMPASS, 12 964 (mean age at baseline 67.2 years) from 455 sites in 32 countries were enrolled in LTOLE and treated with the combination of rivaroxaban and aspirin for a median of 374 additional days (range 1-1191 days). During LTOLE, the incident events per 100 patient years were as follows: for the primary outcome [cardiovascular death, stroke, or myocardial infarction (MI)] 2.35 [95% confidence interval (CI) 2.11-2.61], mortality 1.87 (1.65-2.10), stroke 0.62 (0.50-0.76), and MI 1.02 (0.86-1.19), with CIs that overlapped those seen during the randomized treatment phase with the combination of rivaroxaban and aspirin. The incidence rates for major and minor bleeding were 1.01 (0.86-1.19) and 2.49 (2.24-2.75), compared with 1.67 (1.48-1.87) and 5.11 (95% CI 4.77-5.47), respectively, during the randomized treatment phase with the combination. CONCLUSION: In patients with chronic CAD and/or PAD, extended combination treatment for a median of 1 year and a maximum of 3 years was associated with incidence rates for efficacy and bleeding that were similar to or lower than those seen during the randomized treatment phase, without any new safety signals.

ANMCO Research Center Heart Care Foundation Florence Italy

Bayer AG Pharmaceuticals Research and Development Wuppertal Germany

Brigham and Women's Hospital Harvard Medical School Boston MA USA

Cardiocenter University Hospital Kralovske Vinohrady and 3rd Faculty of Medicine Charles University Prague Czech Republic

Catholic University of Korea Department of Medicine Seoul South Korea

Centre for Cardiovascular Science University of Edinburgh Edinburgh UK

College of Medicine University of Philippines Manila Philippines

Department of Cardiology Dupuytren University Hospital and INSERM 1094 Limoges France

Department of Cardiovascular Sciences University Hospitals Leuven Leuven Belgium

Department of Medicine Jagiellonian University Medical College Krakow Poland

Department of Medicine K2 Karolinska Institutet Stockholm Sweden

Department of Oncocardiology Osaka International Cancer Institute Osaka Japan

Dept of Clinical Medicine University of Aalborg Copenhagen Denmark

Deutsches Zentrum für Herzinsuffizienz Medizinische Klinik 1 Universitätsklinikum Würzburg Würzburg Germany

Division of Cardiology Amphia ziekenhuis Breda Netherlands and Werkgroep Cardiologische centra Nederland Utrecht the Netherlands

Division of Cardiology Department of Medicine Groote Schuur Hospital and the University of Cape Town Cape Town South Africa

Division of Medicine Turku University Hospital and University of Turku Turku Finland

Emergency Cardiology Dept National Scientific Center Institute of Cardiology Kyiv Ukraine

Estudios Clínicos Latino América and Instituto Cardiovascular de Rosario Rosaria Argentina

Facultad de Ciencias de la Salud Eugenio Espejo Universidad UTE Quito Ecuador

Faculty of Medicine Universiti Teknologi MARA Selangor Malaysia

Fuwai Hospital CAMS and PUMC Beijing China

Hungarian Cardiovascular Institute Semmelweis University Budapest Hungary

Institut universitaire de cardiologie et de pneumologie de Québec Québec QC Canada

Institute of Cardiovascular and Medical Sciences University of Glasgow Glasgow UK

International Research Center Hospital Alemão Oswaldo Cruz São Paulo Brazil

Lady Davis Carmel Medical Center and the Ruth and Bruce Rappaport School of Medicine Technion Israel Institute of Technology Haifa Israel

National Medical Research Center of Cardiology Ministry of Healthcare of the Russian Federation Moscow Russia

NUI Galway Department of Medicine Ireland

Population Health Research Institute Hamilton Health Sciences McMaster University Hamilton General Hospital 237 Barton Street East Hamilton Canada

Research Institute Fundación Oftalmológica de Santander Bucaramanga Bucaramanga Colombia

Research Institute HCor Hospital do Coração São Paulo Brazil

School of Public Health and Preventive Medicine Monash University Melbourne Australia

School of Rehabilitation Science McMaster University Hamilton Canada

Thrombosis Research Institute and University College London London UK

Universidad de La Frontera Division of Cardiology Internal Medicine Department Temuco Chile

Université de Paris and Hôpital Bichat Assistance Publique Hôpitaux de Paris Paris France

University of Medicine and Pharmacy Carol Davila; University and Emergency Hospital Bucharest Romania

University of Washington Medical Centre Division of Cardiology Seattle WA USA

University of Washington SOM Division of Cardiology Department of Medicine Seattle WA USA

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