Clinical InvestigationsTotal events and net clinical benefit of rivaroxaban and aspirin in patients with chronic coronary or peripheral artery disease: The COMPASS trial
Section snippets
Methods
COMPASS (ClinicalTrials.gov NCT01776424) was a multicenter, double blind, randomized, placebo-controlled trial of 27,395 chronic CAD and PAD patients that compared rivaroxaban 2.5 mg twice-daily plus aspirin 100 mg once-daily or rivaroxaban 5 mg twice-daily to aspirin 100 mg once-daily (rivaroxaban arm) in addition to contemporary medical therapy.8 Informed consent was obtained from each patient and the study protocol conforms to the ethical guidelines of the 1975 Declaration of Helsinki as
Results
Baseline characteristics are shown in Table I. Of the 27,395 patients enrolled in COMPASS, 1,149 (4.2%) had a primary MACE event and 174 (0.6%) had more than one MACE event over the median 1.9 year follow up. Compared with the baseline characteristics of subjects that did not have a primary MACE outcome, subjects with first and recurrent MACE events were incrementally more likely to be older, hypertensive, have a history of diabetes, have a prior cardiovascular event or coronary artery disease,
Discussion
In patients with chronic CAD and/or PAD enrolled in the COMPASS trial, rivaroxaban with aspirin reduced first and total MACE events by 24% and 25%, respectively, compared with aspirin alone. The absolute risk reduction for recurrent, and therefore total, MACE events was higher than for first events thereby reducing the NNT2y of 77 for first events to NNT2y 63 for total events. The risk reductions for the components of the MACE outcomes were directionally similar for the overall findings for
Conclusions
In patients with chronic CAD or PAD, combination rivaroxaban 2.5 mg BID with aspirin compared with aspirin monotherapy produced similar relative risk reduction but larger absolute risk reduction in total MACE outcomes as compared with first MACE outcomes. The number needed to treat to prevent a first MACE of 77 was reduced to 63 to prevent a first and recurrent MACE outcome. The resultant 20% net clinical benefit of combined rivaroxaban and aspirin treatment demonstrate persistent reduction in
Funding
The COMPASS trial was sponsored by a grant from Bayer to Population Health Research Institute who conducted the trial. The authors have full control and oversight of the data, data analyses, and submission of the manuscript.
Disclosures
Kelley Branch discloses the following: Advisory Boards: Janssen, Bayer. Consultation: Janssen, Bayer, Kestra, Sana, Amgen. Research Support: NIH, Population Health Research Institute, Bayer, Sanofi, Kestra, Eli Lilly.
Jeffrey Probstfield discloses the following: Research support: Bayer.
John Eikelboom reports grants and personal fees from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb/Pfizer, Daiichi Sankyo, Janssen, Astra Zeneca, Eli Lilly, Glaxo Smith Kline, and Sanofi Aventis
Dr. Deepak L.
CRediT authorship contribution statement
Kelley R.H. Branch: Conceptualization, Methodology, Investigation, Writing – original draft, Writing – review & editing. Jeffrey L. Probstfield: Conceptualization, Investigation, Writing – original draft, Writing – review & editing. Jackie Bosch: Conceptualization, Methodology, Investigation, Data curation, Writing – review & editing, Supervision, Project administration. Deepak L. Bhatt: Conceptualization, Methodology, Investigation, Writing – review & editing, Supervision. Aldo P. Maggioni:
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Cited by (1)
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This author takes responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.