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Rationale, Design and Baseline Characteristics of Participants in the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) Trial

Bosch J 1 , Eikelboom JW 2 , Connolly SJ 2 , Bruns NC 3 , Lanius V 3 , Yuan F 2 Show all authors , Misselwitz F 3 , Chen E 3 , Diaz R 4 , Alings M 5 , Lonn EM 2 , Widimsky P 6 , Hori M 7 , Avezum A 8 , Piegas LS 9 , Bhatt DL 10 , Branch KRH 11 , Probstfield JL 12 , Liang Y 13 , Liu L 13 , Zhu J 13 , Maggioni AP 14 , Lopez-Jaramillo P 15 , O'Donnell M 16 , Fox KAA 17 , Kakkar A 18 , Parkhomenko AN 19 , Ertl G 20 , Störk S 20 , Keltai K 21 , Keltai M 21 , Ryden L 22 , Dagenais GR 23 , Pogosova N 24 , Dans AL 25 , Lanas F 26 , Commerford PJ 27 , Torp-Pedersen C 28 , Guzik TJ 29 , Verhamme PB 30 , Vinereanu D 31 , Kim JH 32 , Ha JW 33 , Tonkin AM 34 , Varigos JD 34 , Lewis BS 35 , Felix C 36 , Yusoff K 37 , Steg PG 38 , Aboyans V 39 , Metsarinne KP 40 , Anand SS 2 , Hart RG 2 , Lamy A 2 , Moayyedi P 2 , Leong DP 2 , Sharma M 2 , Yusuf S 2

Affiliations 

  • 1 Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada; School of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada. Electronic address: jackie.bosch@phri.ca
  • 2 Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada
  • 3 Bayer AG, Leverkusen, Germany
  • 4 Estudios Clínicos Latino América and Instituto Cardiovascular de Rosario, Rosario, Argentina
  • 5 Amphia Ziekenhuis and WCN, Utrecht, The Netherlands
  • 6 Cardiocenter, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University Prague, Prague, Czech Republic
  • 7 Osaka International Cancer Institute, Osaka, Japan
  • 8 Instituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil
  • 9 University of Sao Paulo, Sao Paulo, Brazil
  • 10 Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, Boston, Massachusetts, USA
  • 11 University of Washington Medical Centre, Seattle, Washington, USA
  • 12 University of Washington, Seattle, Washington, USA
  • 13 FuWai Hospital, Beijing, China
  • 14 ANMCO Research Center, Florence, Italy
  • 15 Research Institute, FOSCAL-Bucaramanga, Bucaramanga, Colombia
  • 16 National University of Ireland, Galway, Ireland
  • 17 Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, Scotland
  • 18 University College London Hospitals, London, United Kingdom
  • 19 Institute of Cardiology (Ukraine), Kiev, Ukraine
  • 20 Comprehensive Heart Failure Center University and University Hospital Würzburg, Würzburg, Germany
  • 21 Semmelweis University, Budapest, Hungary
  • 22 Karolinska Institutet, Stockholm, Sweden
  • 23 Institut Universitaire de Cardiologie et Pneumologie de Quebec, Quebec City, Quebec, Canada
  • 24 National Research Centre for Preventative Medicine (Moscow), Moscow, Russia
  • 25 University of Philippines - Manila, Manila, The Philippines
  • 26 Universidad de La Frontera, Temuco, Chile
  • 27 Division of Cardiology, Department of Medicine, University of Cape Town, Temuco, Chile
  • 28 University of Aalborg, Copenhagen, Denmark
  • 29 Collegium Medicum Jagiellonian University, Krakow, Poland; University of Glasgow, Glasgow, Scotland, United Kingdom
  • 30 University of Leuven, Flanders, Belgium
  • 31 University of Medicine and Pharmacology Carol Davila University and Emergency Hospital, Bucharest, Romania
  • 32 The Catholic University of Korea, Seoul, Korea
  • 33 Yonsei University College of Medicine, Seoul, Korea
  • 34 Monash University, Melbourne, Australia
  • 35 Lady Davis Carmel Medical Centre, Haifa, Israel
  • 36 Facultad de Ciencias de la Salud Eugenio Espejo UTE, Quito, Ecuador
  • 37 Universiti Teknologi Mara, Selangor, Malaysia
  • 38 Université Paris Diderot, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, FACT, DHU FIRE, INSERM U1148, Paris, France
  • 39 Dupuytren University Hospital, Limoges, France
  • 40 Turku University Central Hospital and Turku University, Turku, Finland
Can J Cardiol, 2017 08;33(8):1027-1035.
PMID: 28754388 DOI: 10.1016/j.cjca.2017.06.001

Abstract

BACKGROUND: Long-term aspirin prevents vascular events but is only modestly effective. Rivaroxaban alone or in combination with aspirin might be more effective than aspirin alone for vascular prevention in patients with stable coronary artery disease (CAD) or peripheral artery disease (PAD). Rivaroxaban as well as aspirin increase upper gastrointestinal (GI) bleeding and this might be prevented by proton pump inhibitor therapy.

METHODS: Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) is a double-blind superiority trial comparing rivaroxaban 2.5 mg twice daily combined with aspirin 100 mg once daily or rivaroxaban 5 mg twice daily vs aspirin 100 mg once daily for prevention of myocardial infarction, stroke, or cardiovascular death in patients with stable CAD or PAD. Patients not taking a proton pump inhibitor were also randomized, using a partial factorial design, to pantoprazole 40 mg once daily or placebo. The trial was designed to have at least 90% power to detect a 20% reduction in each of the rivaroxaban treatment arms compared with aspirin and to detect a 50% reduction in upper GI complications with pantoprazole compared with placebo.

RESULTS: Between February 2013 and May 2016, we recruited 27,395 participants from 602 centres in 33 countries; 17,598 participants were included in the pantoprazole vs placebo comparison. At baseline, the mean age was 68.2 years, 22.0% were female, 90.6% had CAD, and 27.3% had PAD.

CONCLUSIONS: COMPASS will provide information on the efficacy and safety of rivaroxaban, alone or in combination with aspirin, in the long-term management of patients with stable CAD or PAD, and on the efficacy and safety of pantoprazole in preventing upper GI complications in patients receiving antithrombotic therapy.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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