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
Journal
European Heart Journal - Cardiovascular Pharmacotherapy
ISSN
2055-6845
Date Issued
2022-04-06
Author(s)
John W Eikelboom
Jacqueline Bosch
Stuart J Connolly
Jessica Tyrwitt
Keith A A Fox
Eva Muehlhofer
Christoph Neumann
Christoph Tasto
Shrikant I Bangdiwala
Rafael Diaz
Marco Alings
Gilles R Dagenais
Darryl P Leong
Eva M Lonn
Alvaro Avezum
Leopoldo S Piegas
Petr Widimsky
Alexander N. Parkhomenko
Deepak L. Bhatt
Kelley R H Branch
Jeffrey L Probstfield
Patricio Lopez-Jaramillo
Lars Rydén
Nana Pogosova
Katalin Keltai
Matyas Keltai
Georg Ertl
Stefan Stoerk
Antonio L. Dans
Fernando Lanas
Yan Liang
Jun Zhu
Christian Torp-Pedersen
Aldo P. Maggioni
Patrick J Commerford
Tomasz J Guzik
Thomas Vanassche
Peter Verhamme
Martin O'Donnell
Andrew M. Tonkin
John D Varigos
Dragos Vinereanu
Jae-Hyung Kim
Khairul S Ibrahim
Basil S. Lewis
Kaj P Metsarinne
Victor Aboyans
Phillippe Gabriel Steg
Masatsugu Hori
Ajay Kakkar
Sonia S Anand
Andre Lamy
Mukul Sharma
Salim Yusuf
Abstract
<jats:title>Abstract</jats:title>
<jats:sec>
<jats:title>Aims</jats:title>
<jats:p>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).</jats:p>
</jats:sec>
<jats:sec>
<jats:title>Methods and results</jats:title>
<jats:p>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.</jats:p>
</jats:sec>
<jats:sec>
<jats:title>Conclusion</jats:title>
<jats:p>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.</jats:p>
</jats:sec>
<jats:sec>
<jats:title>Aims</jats:title>
<jats:p>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).</jats:p>
</jats:sec>
<jats:sec>
<jats:title>Methods and results</jats:title>
<jats:p>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.</jats:p>
</jats:sec>
<jats:sec>
<jats:title>Conclusion</jats:title>
<jats:p>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.</jats:p>
</jats:sec>