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

Eikelboom JW 1 , Bosch J 1 , Connolly SJ 1 , Tyrwitt J 1 , Fox KAA 2 , Muehlhofer E 3 Show all authors , Neumann C 3 , Tasto C 3 , Bangdiwala SI 1 , Diaz R 4 , Alings M 5 , Dagenais GR 6 , Leong DP 1 , Lonn EM 1 , Avezum A 7 , Piegas LS 8 , Widimsky P 9 , Parkhomenko AN 10 , Bhatt DL 11 , Branch KRH 12 , Probstfield JL 13 , Lopez-Jaramillo P 14 , Rydén L 15 , Pogosova N 16 , Keltai K 17 , Keltai M 17 , Ertl G 18 , Stoerk S 18 , Dans AL 19 , Lanas F 20 , Liang Y 21 , Zhu J 22 , Torp-Pedersen C 22 , Maggioni AP 23 , Commerford PJ 24 , Guzik TJ 25 , Vanassche T 26 , Verhamme P 26 , O'Donnell M 27 , Tonkin AM 28 , Varigos JD 28 , Vinereanu D 29 , Felix C 30 , Kim JH 31 , Ibrahim KS 32 , Lewis BS 33 , Metsarinne KP 34 , Aboyans V 35 , Steg PG 36 , Hori M 37 , Kakkar A 38 , Anand SS 1 , Lamy A 1 , Sharma M 1 , Yusuf S 1

Affiliations 

  • 1 Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton General Hospital, 237 Barton Street East, Hamilton Canada
  • 2 Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK
  • 3 Bayer AG Pharmaceuticals, Research & Development, Wuppertal, Germany
  • 4 Estudios Clínicos Latino América and Instituto Cardiovascular de Rosario, Rosaria, Argentina
  • 5 Division of Cardiology, Amphia ziekenhuis, Breda, Netherlands and Werkgroep Cardiologische centra Nederland (WCN), Utrecht, the Netherlands
  • 6 Institut universitaire de cardiologie et de pneumologie de Québec, Québec, QC, Canada
  • 7 International Research Center, Hospital Alemão Oswaldo Cruz, São Paulo, Brazil
  • 8 Research Institute, HCor, Hospital do Coração, São Paulo, Brazil
  • 9 Cardiocenter, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic
  • 10 Emergency Cardiology Dept., National Scientific Center Institute of Cardiology, Kyiv, Ukraine
  • 11 Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA
  • 12 University of Washington Medical Centre, Division of Cardiology, Seattle, WA, USA
  • 13 University of Washington SOM, Division of Cardiology/Department of Medicine, Seattle WA, USA
  • 14 Research Institute, Fundación Oftalmológica de Santander (FOSCAL)-Bucaramanga, Bucaramanga, Colombia
  • 15 Department of Medicine K2, Karolinska Institutet, Stockholm, Sweden
  • 16 National Medical Research Center of Cardiology, Ministry of Healthcare of the Russian Federation, Moscow, Russia
  • 17 Hungarian Cardiovascular Institute, Semmelweis University, Budapest, Hungary
  • 18 Deutsches Zentrum für Herzinsuffizienz, Medizinische Klinik I, Universitätsklinikum Würzburg, Würzburg, Germany
  • 19 College of Medicine, University of Philippines, Manila, Philippines
  • 20 Universidad de La Frontera, Division of Cardiology, Internal Medicine Department, Temuco, Chile
  • 21 Fuwai Hospital, CAMS & PUMC, Beijing, China
  • 22 Dept of Clinical Medicine, University of Aalborg, Copenhagen, Denmark
  • 23 ANMCO Research Center, Heart Care Foundation, Florence, Italy
  • 24 Division of Cardiology, Department of Medicine, Groote Schuur Hospital and the University of Cape Town, Cape Town, South Africa
  • 25 Department of Medicine, Jagiellonian University Medical College Krakow, Poland
  • 26 Department of Cardiovascular Sciences, University Hospitals Leuven, Leuven, Belgium
  • 27 NUI Galway, Department of Medicine, Ireland
  • 28 School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia
  • 29 University of Medicine and Pharmacy Carol Davila; University and Emergency Hospital, Bucharest, Romania
  • 30 Facultad de Ciencias de la Salud Eugenio Espejo, Universidad UTE, Quito, Ecuador
  • 31 Catholic University of Korea, Department of Medicine, Seoul, South Korea
  • 32 Faculty of Medicine, Universiti Teknologi MARA, Selangor, Malaysia
  • 33 Lady Davis Carmel Medical Center and the Ruth and Bruce Rappaport School of Medicine, Technion-Israel Institute of Technology, Haifa, Israel
  • 34 Division of Medicine, Turku University Hospital and University of Turku, Turku, Finland
  • 35 Department of Cardiology, Dupuytren University Hospital & INSERM 1094, Limoges, France
  • 36 Université de Paris, and Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France
  • 37 Department of Oncocardiology, Osaka International Cancer Institute, Osaka, Japan
  • 38 Thrombosis Research Institute and University College London, London, UK
Eur Heart J Cardiovasc Pharmacother, 2022 Dec 02;8(8):786-795.
PMID: 35383832 DOI: 10.1093/ehjcvp/pvac023

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.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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