Bosch Jackie, Eikelboom John W, Connolly Stuart J, Bruns Nancy Cook, Lanius Vivian, Yuan Fei, Misselwitz Frank, Chen Edmond, Diaz Rafael, Alings Marco, Lonn Eva M, Widimsky Petr, Hori Masatsugu, Avezum Alvaro, Piegas Leopoldo S, Bhatt Deepak L, Branch Kelley R H, Probstfield Jeffrey L, Liang Yan, Liu Lisheng, Zhu Jun, Maggioni Aldo P, Lopez-Jaramillo Patricio, O'Donnell Martin, Fox Keith A A, Kakkar Ajay, Parkhomenko Alexander N, Ertl Georg, Störk Stefan, Keltai Katalin, Keltai Matyas, Ryden Lars, Dagenais Gilles R, Pogosova Nana, Dans Antonio L, Lanas Fernando, Commerford Patrick J, Torp-Pedersen Christian, Guzik Tomasz J, Verhamme Peter B, Vinereanu Dragos, Kim Jae-Hyung, Ha Jong-Won, Tonkin Andrew M, Varigos John D, Lewis Basil S, Felix Camilo, Yusoff Khalid, Steg Philippe Gabriel, Aboyans Victor, Metsarinne Kaj P, Anand Sonia S, Hart Robert G, Lamy Andre, Moayyedi Paul, Leong Darryl P, Sharma Mukul, Yusuf Salim
Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada; School of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada.
Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.
Can J Cardiol. 2017 Aug;33(8):1027-1035. doi: 10.1016/j.cjca.2017.06.001. Epub 2017 Jun 8.
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.
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.
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.
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.
长期服用阿司匹林可预防血管事件，但效果有限。对于稳定型冠状动脉疾病（CAD）或外周动脉疾病（PAD）患者，利伐沙班单药治疗或与阿司匹林联合使用可能比单用阿司匹林在血管预防方面更有效。利伐沙班和阿司匹林都会增加上消化道（GI）出血，而质子泵抑制剂治疗可能预防这种情况。
使用抗凝策略的心血管结局（COMPASS）试验是一项双盲优效性试验，比较每日两次服用2.5mg利伐沙班联合每日一次服用100mg阿司匹林，或每日两次服用5mg利伐沙班与每日一次服用100mg阿司匹林，用于预防稳定型CAD或PAD患者发生心肌梗死、中风或心血管死亡。未服用质子泵抑制剂的患者也采用部分析因设计随机分组，分别每日一次服用40mg泮托拉唑或安慰剂。该试验旨在至少有90%的把握度检测出与阿司匹林相比，各利伐沙班治疗组的事件发生率降低20%，以及与安慰剂相比，泮托拉唑使上消化道并发症降低50%。
2013年2月至2016年5月期间，我们从33个国家的602个中心招募了共27395名参与者；17598名参与者纳入泮托拉唑与安慰剂比较组。基线时，平均年龄为68.2岁，22.0%为女性，90.6%患有CAD，27.3%患有PAD。
COMPASS试验将提供有关利伐沙班单药治疗或与阿司匹林联合使用在稳定型CAD或PAD患者长期管理中的疗效和安全性信息，以及泮托拉唑在预防接受抗栓治疗患者上消化道并发症方面的疗效和安全性信息。
