Long-Term Treatment with the Combination of Rivaroxaban and Aspirin in Patients with Chronic Coronary or Peripheral Artery Disease: Outcomes During the Open Label Extension of the COMPASS trial-Reference-Cited by-同舟云学术

Long-Term Treatment with the Combination of Rivaroxaban and Aspirin in Patients with Chronic Coronary or Peripheral Artery Disease: Outcomes During the Open Label Extension of the COMPASS trial

Published:2022-04-06 Issue:8 Volume:8 Page:786-795
ISSN:2055-6837
Container-title:European Heart Journal - Cardiovascular Pharmacotherapy
language:en
Short-container-title:

Author:

Eikelboom John W¹^ORCID,Bosch Jacqueline¹²,Connolly Stuart J¹,Tyrwitt Jessica¹,Fox Keith A A³,Muehlhofer Eva⁴,Neumann Christoph⁴,Tasto Christoph⁴,Bangdiwala Shrikant I¹,Diaz Rafael⁵^ORCID,Alings Marco⁶^ORCID,Dagenais Gilles R⁷,Leong Darryl P¹,Lonn Eva M¹^ORCID,Avezum Alvaro⁸,Piegas Leopoldo S⁹^ORCID,Widimsky Petr¹⁰,Parkhomenko Alexander N¹¹,Bhatt Deepak L¹²^ORCID,Branch Kelley R H¹³,Probstfield Jeffrey L¹⁴,Lopez-Jaramillo Patricio¹⁵,Rydén Lars¹⁶,Pogosova Nana¹⁷^ORCID,Keltai Katalin¹⁸^ORCID,Keltai Matyas¹⁸,Ertl Georg¹⁹,Stoerk Stefan¹⁹,Dans Antonio L²⁰,Lanas Fernando²¹^ORCID,Liang Yan²²,Zhu Jun²³^ORCID,Torp-Pedersen Christian²³,Maggioni Aldo P²⁴^ORCID,Commerford Patrick J²⁵,Guzik Tomasz J²⁶²⁷,Vanassche Thomas²⁸^ORCID,Verhamme Peter²⁸^ORCID,O'Donnell Martin²⁹,Tonkin Andrew M³⁰,Varigos John D³⁰,Vinereanu Dragos³¹,Felix Camillo³²,Kim Jae-Hyung³³,Ibrahim Khairul S³⁴,Lewis Basil S³⁵,Metsarinne Kaj P³⁶,Aboyans Victor³⁷,Steg Phillippe Gabriel³⁸,Hori Masatsugu³⁹,Kakkar Ajay⁴⁰^ORCID,Anand Sonia S¹,Lamy Andre¹,Sharma Mukul¹,Yusuf Salim¹

Affiliation:

1. Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton General Hospital , 237 Barton Street East, Hamilton Canada

2. School of Rehabilitation Science, McMaster University , Hamilton , Canada

3. Centre for Cardiovascular Science, University of Edinburgh , Edinburgh , UK

4. Bayer AG Pharmaceuticals, Research & Development , Wuppertal , Germany

5. Estudios Clínicos Latino América and Instituto Cardiovascular de Rosario, Rosaria, Argentina

6. Division of Cardiology, Amphia ziekenhuis, Breda, Netherlands and Werkgroep Cardiologische centra Nederland (WCN) , Utrecht , the Netherlands

7. Institut universitaire de cardiologie et de pneumologie de Québec , Québec, QC , Canada

8. International Research Center, Hospital Alemão Oswaldo Cruz , São Paulo , Brazil

9. Research Institute, HCor, Hospital do Coração , São Paulo , Brazil

10. Cardiocenter, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University , Prague , Czech Republic

11. Emergency Cardiology Dept., National Scientific Center Institute of Cardiology , Kyiv , Ukraine

12. Brigham and Women's Hospital, Harvard Medical School , Boston, MA , USA

13. University of Washington Medical Centre , Division of Cardiology, Seattle , WA, USA

14. University of Washington SOM , Division of Cardiology/Department of Medicine, Seattle WA , USA

15. Research Institute, Fundación Oftalmológica de Santander (FOSCAL)—Bucaramanga , Bucaramanga , Colombia

16. Department of Medicine K2, Karolinska Institutet , Stockholm , Sweden

17. National Medical Research Center of Cardiology , Ministry of Healthcare of the Russian Federation, Moscow , Russia

18. Hungarian Cardiovascular Institute , Semmelweis University, Budapest , Hungary

19. Deutsches Zentrum für Herzinsuffizienz, Medizinische Klinik I, Universitätsklinikum Würzburg , Würzburg , Germany

20. College of Medicine, University of Philippines , Manila , Philippines

21. Universidad de La Frontera , Division of Cardiology, Internal Medicine Department, Temuco , Chile

22. Fuwai Hospital, CAMS & PUMC , Beijing , China

23. Dept of Clinical Medicine, University of Aalborg , Copenhagen , Denmark

24. ANMCO Research Center , Heart Care Foundation, Florence , Italy

25. Division of Cardiology, Department of Medicine, Groote Schuur Hospital and the University of Cape Town , Cape Town , South Africa

26. Department of Medicine, Jagiellonian University Medical College Krakow , Poland

27. Institute of Cardiovascular and Medical Sciences, University of Glasgow , Glasgow , UK

28. Department of Cardiovascular Sciences, University Hospitals Leuven , Leuven , Belgium

29. NUI Galway , Department of Medicine , Ireland

30. School of Public Health and Preventive Medicine, Monash University , Melbourne , Australia

31. University of Medicine and Pharmacy Carol Davila; University and Emergency Hospital , Bucharest , Romania

32. Facultad de Ciencias de la Salud Eugenio Espejo, Universidad UTE , Quito , Ecuador

33. Catholic University of Korea , Department of Medicine, Seoul , South Korea

34. Faculty of Medicine, Universiti Teknologi MARA , Selangor , Malaysia

35. Lady Davis Carmel Medical Center and the Ruth and Bruce Rappaport School of Medicine, Technion—Israel Institute of Technology , Haifa , Israel

36. Division of Medicine, Turku University Hospital and University of Turku , Turku , Finland

37. Department of Cardiology, Dupuytren University Hospital & INSERM 1094 , Limoges , France

38. Université de Paris, and Hôpital Bichat, Assistance Publique-Hôpitaux de Paris , Paris , France

39. Department of Oncocardiology, Osaka International Cancer Institute , Osaka , Japan

40. Thrombosis Research Institute and University College London , London , UK

Abstract

Abstract 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.

Funder

Bayer AG

BMS

Janssen Pharmaceuticals

Merck

Pfizer

Sanofi

Servier

Bayer HealthCare

Kowa Pharmaceuticals

CSL Behring

Idorsia