المؤلفون: Eikelboom JW; Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton General Hospital, 237 Barton Street East, Hamilton Canada., Bosch J; Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton General Hospital, 237 Barton Street East, Hamilton Canada.; School of Rehabilitation Science, McMaster University, Hamilton, Canada., Connolly SJ; Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton General Hospital, 237 Barton Street East, Hamilton Canada., Tyrwitt J; Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton General Hospital, 237 Barton Street East, Hamilton Canada., Fox KAA; Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK., Muehlhofer E; Bayer AG Pharmaceuticals, Research & Development, Wuppertal, Germany., Neumann C; Bayer AG Pharmaceuticals, Research & Development, Wuppertal, Germany., Tasto C; Bayer AG Pharmaceuticals, Research & Development, Wuppertal, Germany., Bangdiwala SI; Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton General Hospital, 237 Barton Street East, Hamilton Canada., Diaz R; Estudios Clínicos Latino América and Instituto Cardiovascular de Rosario, Rosaria, Argentina., Alings M; Division of Cardiology, Amphia ziekenhuis, Breda, Netherlands and Werkgroep Cardiologische centra Nederland (WCN), Utrecht, the Netherlands., Dagenais GR; Institut universitaire de cardiologie et de pneumologie de Québec, Québec, QC, Canada., Leong DP; Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton General Hospital, 237 Barton Street East, Hamilton Canada., Lonn EM; Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton General Hospital, 237 Barton Street East, Hamilton Canada., Avezum A; International Research Center, Hospital Alemão Oswaldo Cruz, São Paulo, Brazil., Piegas LS; Research Institute, HCor, Hospital do Coração, São Paulo, Brazil., Widimsky P; Cardiocenter, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic., Parkhomenko AN; Emergency Cardiology Dept., National Scientific Center Institute of Cardiology, Kyiv, Ukraine., Bhatt DL; Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA., Branch KRH; University of Washington Medical Centre, Division of Cardiology, Seattle, WA, USA., Probstfield JL; University of Washington SOM, Division of Cardiology/Department of Medicine, Seattle WA, USA., Lopez-Jaramillo P; Research Institute, Fundación Oftalmológica de Santander (FOSCAL)-Bucaramanga, Bucaramanga, Colombia., Rydén L; Department of Medicine K2, Karolinska Institutet, Stockholm, Sweden., Pogosova N; National Medical Research Center of Cardiology, Ministry of Healthcare of the Russian Federation, Moscow, Russia., Keltai K; Hungarian Cardiovascular Institute, Semmelweis University, Budapest, Hungary., Keltai M; Hungarian Cardiovascular Institute, Semmelweis University, Budapest, Hungary., Ertl G; Deutsches Zentrum für Herzinsuffizienz, Medizinische Klinik I, Universitätsklinikum Würzburg, Würzburg, Germany., Stoerk S; Deutsches Zentrum für Herzinsuffizienz, Medizinische Klinik I, Universitätsklinikum Würzburg, Würzburg, Germany., Dans AL; College of Medicine, University of Philippines, Manila, Philippines., Lanas F; Universidad de La Frontera, Division of Cardiology, Internal Medicine Department, Temuco, Chile., Liang Y; Fuwai Hospital, CAMS & PUMC, Beijing, China., Zhu J; Dept of Clinical Medicine, University of Aalborg, Copenhagen, Denmark., Torp-Pedersen C; Dept of Clinical Medicine, University of Aalborg, Copenhagen, Denmark., Maggioni AP; ANMCO Research Center, Heart Care Foundation, Florence, Italy., Commerford PJ; Division of Cardiology, Department of Medicine, Groote Schuur Hospital and the University of Cape Town, Cape Town, South Africa., Guzik TJ; Department of Medicine, Jagiellonian University Medical College Krakow, Poland.; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK., Vanassche T; Department of Cardiovascular Sciences, University Hospitals Leuven, Leuven, Belgium., Verhamme P; Department of Cardiovascular Sciences, University Hospitals Leuven, Leuven, Belgium., O'Donnell M; NUI Galway, Department of Medicine, Ireland., Tonkin AM; School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia., Varigos JD; School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia., Vinereanu D; University of Medicine and Pharmacy Carol Davila; University and Emergency Hospital, Bucharest, Romania., Felix C; Facultad de Ciencias de la Salud Eugenio Espejo, Universidad UTE, Quito, Ecuador., Kim JH; Catholic University of Korea, Department of Medicine, Seoul, South Korea., Ibrahim KS; Faculty of Medicine, Universiti Teknologi MARA, Selangor, Malaysia., Lewis BS; Lady Davis Carmel Medical Center and the Ruth and Bruce Rappaport School of Medicine, Technion-Israel Institute of Technology, Haifa, Israel., Metsarinne KP; Division of Medicine, Turku University Hospital and University of Turku, Turku, Finland., Aboyans V; Department of Cardiology, Dupuytren University Hospital & INSERM 1094, Limoges, France., Steg PG; Université de Paris, and Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France., Hori M; Department of Oncocardiology, Osaka International Cancer Institute, Osaka, Japan., Kakkar A; Thrombosis Research Institute and University College London, London, UK., Anand SS; Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton General Hospital, 237 Barton Street East, Hamilton Canada., Lamy A; Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton General Hospital, 237 Barton Street East, Hamilton Canada., Sharma M; Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton General Hospital, 237 Barton Street East, Hamilton Canada., Yusuf S; Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton General Hospital, 237 Barton Street East, Hamilton Canada.

المصدر: European heart journal. Cardiovascular pharmacotherapy [Eur Heart J Cardiovasc Pharmacother] 2022 Dec 02; Vol. 8 (8), pp. 786-795.

نوع المنشور: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

بيانات الدورية: Publisher: Oxford University Press Country of Publication: England NLM ID: 101669491 Publication Model: Print Cited Medium: Internet ISSN: 2055-6845 (Electronic) NLM ISO Abbreviation: Eur Heart J Cardiovasc Pharmacother Subsets: MEDLINE

مواضيع طبية MeSH: Myocardial Infarction*/epidemiology , Peripheral Arterial Disease*/diagnosis , Peripheral Arterial Disease*/drug therapy , Peripheral Arterial Disease*/epidemiology , Stroke*/epidemiology, Humans ; Infant ; Aspirin ; Drug Therapy, Combination ; Rivaroxaban

مستخلص: 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.
(© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.)