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Bosch, Jackie, MSc, PhD; Eikelboom, John W., MBBS, MSc; Connolly, Stuart J., MD; Cook Bruns, Nancy, MD; Lanius, Vivian, PhD; Yuan, Fei, MMath; Misselwitz, Frank, MD, PhD; Chen, Edmond, MD; Diaz, Rafael, MD; Alings, Marco, MD, PhD; Lonn, Eva M., MD, MSc; Widimsky, Petr, MD, DSc; Hori, Masatsugu, MD, PhD; Avezum, Alvaro, MD, PhD; Piegas, Leopoldo S., MD; Bhatt, Deepak L., MD, MPH; Branch, Kelley R.H., MD, MSc; Probstfield, Jeffrey L., MD; Liang, Yan, MD; Liu, Lisheng, MD; Zhu, Jun, MD; Maggioni, Aldo P., MD; Lopez-Jaramillo, Patricio, MD, PhD; O’Donnell, Martin, MB, PhD; Fox, Keith A.A., BSc, MBChB; Kakkar, Ajay, MBBS, PhD, BSc, MA; Parkhomenko, Alexander N., MD, PhD; Ertl, Georg, MD; Störk, Stefan, MD, PhD; Keltai, Katalin, MD; Keltai, Matyas, MD; Ryden, Lars, MD; Dagenais, Gilles R., MD; Pogosova, Nana, MD, PhD; Dans, Antonio L., MD, MSc; Lanas, Fernando, PhD; Commerford, Patrick J., MBChB; Torp-Pedersen, Christian, MD; Guzik, Tomasz J., MD, PhD, MSc; Verhamme, Peter B., MD; Vinereanu, Dragos, MD, PhD; Kim, Jae-Hyung, MD, PhD; Ha, Jong-Won, MD, PhD; Tonkin, Andrew M., MD, MBBS; Varigos, John D., BSc (Hon); Lewis, Basil S., MD; Felix, Camilo, MD, MSc; Yusoff, Khalid, MBBS; Steg, Philippe Gabriel, MD; Aboyans, Victor, MD, PhD; Metsarinne, Kaj P., MD, PhD; Anand, Sonia S., MD, PhD; Hart, Robert G., MD; Lamy, Andre, MD, MHSc; Moayyedi, Paul, BSc, MBChB, PhD; Sharma, Mukul, MD, MSc; Yusuf, Salim, MBBS,-DPhil
Canadian journal of cardiology, 08/2017, Letnik: 33, Številka: 8Journal Article
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). Both rivaroxaban and aspirin increase upper gastrointestinal (GI) bleeding and this might be prevented by proton pump inhibitor (PPI) therapy. Methods COMPASS is a double-blind superiority trial comparing rivaroxaban 2.5mg twice-daily in combination with aspirin 100mg once-daily or rivaroxaban 5mg twice-daily versus aspirin 100mg once-daily for prevention of myocardial infarction, stroke, or cardiovascular death in patients with stable CAD or PAD. Patients not taking a PPI were also randomized, using a partial factorial design, to pantoprazole 40mg 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 centers in 33 countries; 17,603 participants were included in the pantoprazole versus placebo comparison. At baseline, mean age was 68.2years, 22.0% were female, 90.6% had CAD, and 27.3% had PAD. Conclusion 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.
