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Randomized Controlled Trial
. 2024 Aug;22(8):2227-2233.
doi: 10.1016/j.jtha.2024.03.030. Epub 2024 May 9.

Perioperative management and outcomes in patients receiving low-dose rivaroxaban and/or aspirin: a subanalysis of the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial

James D Douketis  1 , Qilong Yi  2 , Deepak L Bhatt  3 , Eva Muehlhofer  4 , Michael K Wang  5 , Stuart Connolly  5 , Salim Yusuf  3 , Aldo P Maggioni  6 , John W Eikelboom  7
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Free article
Randomized Controlled Trial

Perioperative management and outcomes in patients receiving low-dose rivaroxaban and/or aspirin: a subanalysis of the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial

James D Douketis et al. J Thromb Haemost. 2024 Aug.
Free article

Abstract

Background: No study has investigated the perioperative management and clinical outcomes in patients who are receiving rivaroxaban 2.5 mg twice a day and acetylsalicylic acid (ASA) 81 to 100 mg daily.

Objective: To assess perioperative management and outcomes in patients who are receiving low-dose rivaroxaban, 2.5 mg twice-daily, and low-dose ASA, 81 to 100 mg daily. To assess perioperative management and outcomes in patients who are receiving low-dose rivaroxaban, 2.5 mg twice-daily, and low-dose ASA, 81 to 100 mg daily.

Methods: Subanalysis of the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial was performed to assess perioperative management and clinical outcomes in patients with stable coronary or peripheral artery disease who were randomized to receive rivaroxaban 2.5 mg twice a day plus ASA 100 mg daily, rivaroxaban 5 mg twice a day, or ASA 100 mg daily. Patients studied required a surgery/procedure during the trial. The study outcomes, which included myocardial infarction, angina, stroke, acute limb ischemia, bleeding, and death, were assessed according to treatment allocation.

Results: There were 2632 patients studied (mean age, 68 years; 80% male) who had a surgery/procedure, comprising percutaneous coronary interventions (∼43%), carotid or other arterial angioplasty (∼15%), pacemaker or internal cardiac defibrillator implantation (∼9%), and coronary artery bypass graft surgery (∼7%). Perioperative study drug management varied, with about one-third of patients not interrupting study drug and the remainder interrupting it between 1 and ≥10 days preprocedure. The incidences of adverse outcomes across treatment groups were 12.7% to 15.3% for myocardial ischemia, 0.8% to 1.2% for stroke, 0.1% to 0.2% for venous thromboembolism, and 3.1% to 4.2% for any bleeding. There was no statistically significant difference in outcome rates across treatment groups.

Conclusion: In patients in the COMPASS trial who required a surgery/procedure, there was no significant difference in perioperative adverse outcomes whether patients were receiving rivaroxaban 2.5 mg twice a day and ASA 100 mg daily, rivaroxaban 5 mg twice a day, or ASA alone.

Keywords: anticoagulant; antiplatelet; aspirin; invasive procedure; perioperative; rivaroxaban; surgery.

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Conflict of interest statement

Declaration of competing interests There was no funding provided for the development and for any other aspect of the work in this manuscript. J.D.D. reports consulting and lecture honoraria from Servier Canada, Leo Pharma, Pfizer, and Fresinius Kabi. Q.L. reports no disclosures. D.L.B. reports advisory for Angiowave, Bayer, Boehringer Ingelheim, Cardax, CellProthera, Cereno Scientific, Elsevier Practice Update Cardiology, High Enroll, Janssen, Level Ex, McKinsey, Medscape Cardiology, Merck, MyoKardia, NirvaMed, Novo Nordisk, PhaseBio, PLx Pharma, Regado Biosciences, and Stasys and research funding from Abbott, Acesion Pharma, Afimmune, Aker Biomarine, Amarin, Amgen, AstraZeneca, Bayer, Beren, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Cardax, CellProthera, Cereno Scientific, Chiesi, CinCor, CSL Behring, Eisai, Ethicon, Faraday Pharmaceuticals, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Garmin, HLS Therapeutics, Idorsia, Ironwood, Ischemix, Janssen, Javelin, Lexicon, Lilly, Medtronic, Merck, Moderna, MyoKardia, NirvaMed, Novartis, Novo Nordisk, Owkin, Pfizer, PhaseBio, PLx Pharma, Recardio, Regeneron, Reid Hoffman Foundation, Roche, Sanofi, Stasys, Synaptic, The Medicines Company, Youngene, and 89Bio. E.M. reports being employed as a global clinical lead by Bayer AG, Germany. M.K.W. reports no disclosures. S.C. reports grants from Bayer AG and personal fees from BMS, Pfizer, Portola, Boehringer Ingelheim, Servier, Daiichi Sankyo, and Medtronic. S.Y. reports grants and personal fees from Bayer, Boehringer Ingelheim, AstraZeneca, Bristol-Myers Squibb, and Cadila. A.P.M. reports receiving personal fees from Bayer, AstraZeneca, and Novartis. J.W.E. reports grants and/or personal fees from Anthos, Bayer AG, Boehringer Ingelheim, Bristol-Myers Squibb/Pfizer, Daiichi Sankyo, Idorsia, Janssen, Astra Zeneca, Eli Lilly, GlaxoSmithKlein, and Sanofi Aventis.

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