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; Qilong Yi; Deepak L Bhatt; Eva Muehlhofer; Michael K Wang; Stuart Connolly; Salim Yusuf; Aldo P Maggioni; John W Eikelboom

doi:10.1016/j.jtha.2024.03.030

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

J Thromb Haemost. 2024 May 9:S1538-7836(24)00257-5. doi: 10.1016/j.jtha.2024.03.030. Online ahead of print.

Authors

James D Douketis¹, Qilong Yi², Deepak L Bhatt³, Eva Muehlhofer⁴, Michael K Wang⁵, Stuart Connolly⁵, Salim Yusuf³, Aldo P Maggioni⁶, John W Eikelboom⁷

Affiliations

¹ Department of Medicine, McMaster University, Hamilton, Ontario, Canada; Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, Ontario, Canada. Electronic address: jdouket@mcmaster.ca.
² Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.
³ Mt. Sinai Fuster Heart Hospital, Icahn School of Medicine at Mt. Sinai, New York, New York, USA.
⁴ Bayer AG Research & Development, Wuppertal, Germany.
⁵ Department of Medicine, McMaster University, Hamilton, Ontario, Canada; Mt. Sinai Fuster Heart Hospital, Icahn School of Medicine at Mt. Sinai, New York, New York, USA.
⁶ Maria Cecilia Hospital, GVM Care and Research, Cotignola, Italy.
⁷ Department of Medicine, McMaster University, Hamilton, Ontario, Canada; Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, Ontario, Canada; Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.

PMID: 38729576
DOI: 10.1016/j.jtha.2024.03.030

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.