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.

Amphia Ziekenhuis and WCN Utrecht The Netherlands

ANMCO Research Center Florence Italy

Bayer AG Leverkusen Germany

Brigham and Women's Hospital Heart and Vascular Center Harvard Medical School Boston Massachusetts USA

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

Centre for Cardiovascular Science University of Edinburgh Edinburgh Scotland

Collegium Medicum Jagiellonian University Krakow Poland

Comprehensive Heart Failure Center University and University Hospital Würzburg Würzburg Germany

Division of Cardiology Department of Medicine University of Cape Town Temuco Chile

Dupuytren University Hospital Limoges France

Estudios Clínicos Latino América and Instituto Cardiovascular de Rosario Rosario Argentina

Facultad de Ciencias de la Salud Eugenio Espejo UTE Quito Ecuador

FuWai Hospital Beijing China

Institut Universitaire de Cardiologie et Pneumologie de Quebec Quebec City Quebec Canada

Institute of Cardiology Kiev Ukraine

Instituto Dante Pazzanese de Cardiologia Sao Paulo Brazil

Karolinska Institutet Stockholm Sweden

Lady Davis Carmel Medical Centre Haifa Israel

Monash University Melbourne Australia

National Research Centre for Preventative Medicine Moscow Russia

National University of Ireland Galway Ireland

Osaka International Cancer Institute Osaka Japan

Population Health Research Institute McMaster University and Hamilton Health Sciences Hamilton Ontario Canada

Research Institute FOSCAL Bucaramanga Bucaramanga Colombia

School of Rehabilitation Science McMaster University Hamilton Ontario Canada

Semmelweis University Budapest Hungary

The Catholic University of Korea Seoul Korea

Turku University Central Hospital and Turku University Turku Finland

Universidad de La Frontera Temuco Chile

Université Paris Diderot Hôpital Bichat Assistance Publique Hôpitaux de Paris FACT DHU FIRE INSERM U1148 Paris France

Universiti Teknologi Mara Selangor Malaysia

University College London Hospitals London United Kingdom

University of Aalborg Copenhagen Denmark

University of Glasgow Glasgow Scotland United Kingdom

University of Leuven Flanders Belgium

University of Medicine and Pharmacology Carol Davila University and Emergency Hospital Bucharest Romania

University of Philippines Manila Manila The Philippines

University of Sao Paulo Sao Paulo Brazil

University of Washington Medical Centre Seattle Washington USA

University of Washington Seattle Washington USA

Yonsei University College of Medicine Seoul Korea

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$a Bosch, Jackie $u 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.

245    10

$a Rationale, Design and Baseline Characteristics of Participants in the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) Trial / $c J. Bosch, JW. Eikelboom, SJ. Connolly, NC. Bruns, V. Lanius, F. Yuan, F. Misselwitz, E. Chen, R. Diaz, M. Alings, EM. Lonn, P. Widimsky, M. Hori, A. Avezum, LS. Piegas, DL. Bhatt, KRH. Branch, JL. Probstfield, Y. Liang, L. Liu, J. Zhu, AP. Maggioni, P. Lopez-Jaramillo, M. O'Donnell, KAA. Fox, A. Kakkar, AN. Parkhomenko, G. Ertl, S. Störk, K. Keltai, M. Keltai, L. Ryden, GR. Dagenais, N. Pogosova, AL. Dans, F. Lanas, PJ. Commerford, C. Torp-Pedersen, TJ. Guzik, PB. Verhamme, D. Vinereanu, JH. Kim, JW. Ha, AM. Tonkin, JD. Varigos, BS. Lewis, C. Felix, K. Yusoff, PG. Steg, V. Aboyans, KP. Metsarinne, SS. Anand, RG. Hart, A. Lamy, P. Moayyedi, DP. Leong, M. Sharma, S. Yusuf,

520    9_

$a 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.

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$a Eikelboom, John W $u Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.

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$a Bruns, Nancy Cook $u Bayer AG, Leverkusen, Germany.

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$a Misselwitz, Frank $u Bayer AG, Leverkusen, Germany.

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$a Chen, Edmond $u Bayer AG, Leverkusen, Germany.

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$a Lonn, Eva M $u Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.

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$a Hori, M. $d 1945- $7 xx0247187 $u Osaka International Cancer Institute, Osaka, Japan.

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$a Avezum, Alvaro $u Instituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil. $7 gn_A_00010338

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$a Piegas, Leopoldo S $u University of Sao Paulo, Sao Paulo, Brazil.

700    1_

$a Bhatt, Deepak L $u Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, Boston, Massachusetts, USA.

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$a Branch, Kelley R H $u University of Washington Medical Centre, Seattle, Washington, USA.

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$a Probstfield, Jeffrey L $u University of Washington, Seattle, Washington, USA.

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$a Liang, Yan $u FuWai Hospital, Beijing, China.

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$a O'Donnell, Martin $u National University of Ireland, Galway, Ireland.

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$a Fox, Keith A A $u Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, Scotland.

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$a Kakkar, Ajay $u University College London Hospitals, London, United Kingdom.

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$a Parkhomenko, Alexander N $u Institute of Cardiology (Ukraine), Kiev, Ukraine.

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$a Ertl, Georg $u Comprehensive Heart Failure Center University and University Hospital Würzburg, Würzburg, Germany.

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$a Störk, Stefan $u Comprehensive Heart Failure Center University and University Hospital Würzburg, Würzburg, Germany.

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$a Keltai, Katalin $u Semmelweis University, Budapest, Hungary.

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$a Keltai, Matyas $u Semmelweis University, Budapest, Hungary.

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$a Ryden, Lars $u Karolinska Institutet, Stockholm, Sweden.

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$a Dagenais, Gilles R $u Institut Universitaire de Cardiologie et Pneumologie de Quebec, Quebec City, Quebec, Canada.

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$a Pogosova, Nana $u National Research Centre for Preventative Medicine (Moscow), Moscow, Russia.

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$a Dans, Antonio L $u University of Philippines - Manila, Manila, The Philippines.

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$a Lanas, Fernando $u Universidad de La Frontera, Temuco, Chile.

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$a Commerford, Patrick J $u Division of Cardiology, Department of Medicine, University of Cape Town, Temuco, Chile.

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$a Torp-Pedersen, Christian $u University of Aalborg, Copenhagen, Denmark.

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$a Guzik, Tomasz J $u Collegium Medicum Jagiellonian University, Krakow, Poland; University of Glasgow, Glasgow, Scotland, United Kingdom.

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$a Verhamme, Peter B $u University of Leuven, Flanders, Belgium.

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$a Vinereanu, Dragos $u University of Medicine and Pharmacology Carol Davila University and Emergency Hospital, Bucharest, Romania.

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$a Kim, Jae-Hyung $u The Catholic University of Korea, Seoul, Korea.

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$a Ha, Jong-Won $u Yonsei University College of Medicine, Seoul, Korea.

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$a Tonkin, Andrew M $u Monash University, Melbourne, Australia.

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$a Varigos, John D $u Monash University, Melbourne, Australia.

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$a Lewis, Basil S $u Lady Davis Carmel Medical Centre, Haifa, Israel.

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$a Felix, Camilo $u Facultad de Ciencias de la Salud Eugenio Espejo UTE, Quito, Ecuador.

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$a Yusoff, Khalid $u Universiti Teknologi Mara, Selangor, Malaysia.

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$a Steg, Philippe Gabriel $u Université Paris Diderot, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, FACT, DHU FIRE, INSERM U1148, Paris, France.

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$a Aboyans, Victor $u Dupuytren University Hospital, Limoges, France. $7 gn_A_00000689

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$a Metsarinne, Kaj P $u Turku University Central Hospital and Turku University, Turku, Finland.

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$a Anand, Sonia S $u Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.

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$a Hart, Robert G $u Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.

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$a Lamy, Andre $u Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.

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$a Moayyedi, Paul $u Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.

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$a Leong, Darryl P $u Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.

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$a Sharma, Mukul $u Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.

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