Total events and net clinical benefit of rivaroxaban and aspirin in patients with chronic coronary or peripheral artery disease: The COMPASS trial - 14/03/23

Doi : 10.1016/j.ahj.2023.01.008

Kelley R.H. Branch, MD, MSc ^a,^{^{#
This author takes responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.},}^⁎ , Jeffrey L. Probstfield, MD ^a,^{^{#
This author takes responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.}}, Jackie Bosch, PhD ^b,^{^{#
This author takes responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.}}, Deepak L. Bhatt, MD, MPH ^c,^{^{#
This author takes responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.}}, Aldo P. Maggioni, MD ^d,^{^{#
This author takes responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.}}, Eva Muehlhofer, MD ^e,^{^{#
This author takes responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.}}, Alvaro Avezum, MD ^f,^{^{#
This author takes responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.}}, Petr Widimsky, MD ^g,^{^{#
This author takes responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.}}, Stuart J. Connolly, MD ^b,^{^{#
This author takes responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.}}, Quilong Yi, PhD ^b,^{^{#
This author takes responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.}}, Olga Shestakovska, MSc ^b,^{^{#
This author takes responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.}}, Salim Yusuf, DPhil ^b,^{^{#
This author takes responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.}}, John W. Eikelboom, MBBS ^b,^{^{#
This author takes responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.}}
^a University of Washington, Division of Cardiology, Seattle, WA
^b Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada
^c Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, Boston, MA
^d National Association of Hospital Cardiologists Research Center (ANMCO) Research Center, Firenze, Toscano, Italy
^e Bayer AG, Wuppertal, North Rhine-Westphalia, Germany
^f Dante Pazzanese Institute of Cardiology and Hospital Alemão Oswaldo Cruz, São Paulo, São Paulo, Brazil
^g Cardiocenter, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague

^⁎Reprint requests: Kelley R Branch, MD, MSc, University of Washington, Division of Cardiology, 1959 NE Pacific St, Box 356422, Seattle, WA, 98195.University of Washington, Division of Cardiology1959 NE Pacific St, Box 356422SeattleWA98195

ABSTRACT

Background

Low dose rivaroxaban with aspirin reduced major cardiovascular events (MACE) compared to aspirin alone in patients with cardiovascular disease although effects on total events are unknown.

Methods

The COMPASS clinical trial randomized 27,395 participants with chronic coronary and/or peripheral artery disease to rivaroxaban 2.5 mg twice daily plus aspirin 100 mg daily, rivaroxaban 5 mg twice daily alone, or aspirin 100 mg daily. We analyzed total (first and recurrent) MACE outcomes of cardiovascular death, stroke, or myocardial infarction, and the primary safety outcome of major bleeding. Exploratory analyses included on-treatment and net clinical benefit. Total MACE and safety events were modeled for each treatment.

Results

MACE events were lowest in rivaroxaban with aspirin (379 first MACE, 432 total MACE) compared with rivaroxaban (448 first, 508 total) or aspirin alone (496 first, 574 total). Rivaroxaban and aspirin reduced total MACE events compared with aspirin alone [HR 0.75, 95% CI 0.66-0.85, P < .0001, number needed to treat for 2 years (NNT_2y) of 63]. Total major bleeding was higher for rivaroxaban with aspirin compared to aspirin, but severe bleeding was not increased. The net clinical benefit of rivaroxaban plus aspirin was 20% higher compared with aspirin alone [HR 0.80 (95% CI 16.3%-31.6%)]. Rivaroxaban alone had no benefit on MACE outcomes compared with aspirin alone. MACE outcomes were similar for those on and off randomized treatment.

Conclusions

Low dose rivaroxaban with aspirin significantly reduces first and total cardiovascular events compared with aspirin alone with a NNT_2y of 63 and a 20% net clinical benefit.

Trial Registration

NCT01776424. NCT01776424

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Abbreviations : MACE, NCB, NNT2y, ISTH

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Esportazione

Vol 258

P. 60-68 - Aprile 2023 Ritorno al numero

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Total events and net clinical benefit of rivaroxaban and aspirin in patients with chronic coronary or peripheral artery disease: The COMPASS trial - 14/03/23

ABSTRACT

Background

Methods

Results

Conclusions

Trial Registration

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