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

John Eikelboom (1) , Jacqueline Bosch (1) , Stuart Connolly (1) , Jessica Tyrwitt (1) , Keith Fox (2) , Eva Muehlhofer (3) , Christoph Neumann (3) , Christoph Tasto (3) , Shrikant Bangdiwala (1) , Rafael Diaz (4) , Marco Alings (5) , Gilles Dagenais (6) , Darryl Leong (1) , Eva Lonn (1) , Alvaro Avezum (7) , Leopoldo Piegas (8) , Petr Widimsky (9) , Alexander Parkhomenko , Deepak Bhatt (10) , Kelley Branch (11) , Jeffrey Probstfield (12) , Patricio Lopez-Jaramillo (13) , Lars Rydén (14) , Nana Pogosova (15) , Katalin Keltai (16) , Matyas Keltai (16) , Georg Ertl (17) , Stefan Stoerk (17) , Antonio Dans (18) , Fernando Lanas (19) , Yan Liang (20) , Jun Zhu (20) , Christian Torp-Pedersen (21) , Aldo Maggioni (22) , Patrick Commerford (23) , Tomasz Guzik (24) , Thomas Vanassche (25) , Peter Verhamme (25) , Martin O'Donnell (26) , Andrew Tonkin (27) , John Varigos (27) , Dragos Vinereanu (28) , Camillo Felix (29) , Jae-Hyung Kim (30) , Khairul Ibrahim , Basil Lewis , Kaj Metsarinne (31) , Victor Aboyans (32, 33) , Phillippe Gabriel Steg (34) , Masatsugu Hori (35) , Ajay Kakkar (36) , Sonia Anand (1) , Andre Lamy (1) , Mukul Sharma (1) , Salim Yusuf (1)

1 Hamilton Health Sciences
2 University of Edinburgh
3 Bayer AG [Wuppertal, Germany]
4 ECLAEstudios Clínicos Latino América & Instituto Cardiovascular de Rosario), Rosario, Argentina
5 Department of Cardiology, Division Heart and Lungs, University Medical Center Utrecht, University of Utrecht, Utrecht
6 IUCPQ - Institut Universitaire de Cardiologie et de Pneumologie de Québec
7 Oswaldo Cruz German Hospital [São Paulo]
8 DEPARTMENT OF CHEMISTRY - H.C.Orsted Institute
9 Kralovske Vinohrady University Hospital
10 BWH - Brigham & Women’s Hospital [Boston]
11 University of Washington Medical Center
12 University of Washington [Seattle]
13 Université de Bucaramanga
14 Department of medicine [Stockholm]
15 MOSCOU - CRC - Cardiology Research Center
16 Semmelweis University [Budapest]
17 University of Würzburg = Universität Würzburg
18 University of Santo Tomas [Manila, Philippines]
19 Universidad de la frontera [Chile]
20 Fuwai Hospital
21 AAU - Aalborg University [Denmark]
22 ANMCO Research Center, Firenze,Italy
23 Groote Schuur Hospital, University of Cape Town, South Africa.
24 UJ - Uniwersytet Jagielloński w Krakowie = Jagiellonian University
25 Department of Cardiology [K.U.Leuven]
26 NUI Galway - National University of Ireland [Galway]
27 CCS - Monash Central Clinical School [Melbourne]
28 UMPCD - University of Medicine and Pharmacy “Carol Davila” Bucharest
29 UTE - Universidad Tecnologica Equinoccial [Quito, Ecuador]
30 The Catholic University of Korea [Seoul, Korea]
31 TYKS - Turku University Hospital
32 EpiMaCT - Epidémiologie des Maladies Chroniques en zone tropicale
33 Service de cardiologie [CHU Limoges]
34 AP-HP - Hôpital Bichat - Claude Bernard [Paris]
35 OIU - Osaka International University
36 AKK - Thrombosis Research Institute

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 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 1–1 191 days). During LTOLE, the incident events per 100 patient years were: for the primary outcome (cardiovascular [CV] death, stroke, or myocardial infarction [MI]) 2.35 (95% 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 confidence intervals that overlapped those seen during the randomized treatment phase with the combination of rivaroxaban and aspirin. The incidence rates for major bleeding were 1.01 (0.86–1.19) and for minor bleeding 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.

Mots clés: Aspirin; Coronary artery disease; Peripheral artery disease; Rivaroxaban

Domaines: Santé publique et épidémiologie

John Eikelboom, Jacqueline Bosch, Stuart Connolly, Jessica Tyrwitt, Keith Fox, et al.. 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. European Heart Journal - Cardiovascular Pharmacotherapy, 2022, ⟨10.1093/ehjcvp/pvac023⟩. ⟨hal-03676188⟩