Original Research

DOI: 10.4244/EIJ-D-23-00396

Antithrombotic therapy for stable coronary artery disease and atrial fibrillation in patients with and without revascularisation: the AFIRE trial

Takashi Noda1, MD, PhD; Kotaro Nochioka1, MD, PhD; Koichi Kaikita2, MD, PhD; Masaharu Akao3, MD, PhD; Junya Ako4, MD, PhD; Tetsuya Matoba5, MD, PhD; Masato Nakamura6, MD, PhD; Katsumi Miyauchi7, MD, PhD; Nobuhisa Hagiwara8, MD, PhD; Kazuo Kimura9, MD, PhD; Atsushi Hirayama10, MD, PhD; Kunihiko Matsui11, MD, MPH; Hisao Ogawa12, MD, PhD; Satoshi Yasuda1, MD, PhD; on behalf of the AFIRE investigators

Abstract

BACKGROUND: The Atrial Fibrillation and Ischemic Events with Rivaroxaban in Patients with Stable Coronary Artery Disease (AFIRE) trial demonstrated non-inferior efficacy endpoints for rivaroxaban monotherapy versus combination therapy (rivaroxaban plus a single antiplatelet) and superior safety endpoints in patients with atrial fibrillation and stable coronary artery disease.

AIMS: This post hoc analysis investigated whether the AFIRE trial results reflected the presence or absence of prior revascularisation.

METHODS: Among 2,215 patients, 1,697 (76.6%) had previously undergone revascularisation, and the remaining 518 (23.4%) had not undergone prior revascularisation. The primary efficacy endpoint was a composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularisation, or death from any cause, while the primary safety endpoint was major bleeding.

RESULTS: In 1,697 patients with prior revascularisation, the efficacy and safety endpoints were superior for monotherapy versus combination therapy (efficacy: hazard ratio [HR] 0.62, 95% confidence interval [CI]: 0.45-0.85; p=0.003; safety: HR 0.62, 95% CI: 0.39-0.98; p=0.042). Among 518 without prior revascularisation, there were no significant differences in endpoints (efficacy: HR 1.19, 95% CI: 0.67-2.12; p=0.554; safety: HR 0.47, 95% CI: 0.18-1.26; p=0.134). There was borderline interaction of the efficacy endpoints (p=0.055) between two treatments. The safety benefit of monotherapy on any bleeding was significant in patients without prior revascularisation (HR 0.59, 95% CI: 0.38-0.93; p=0.022).

CONCLUSIONS: In high-risk thrombosis patients with a history of prior revascularisation, rivaroxaban monotherapy versus combination therapy demonstrated favourable safety and efficacy outcomes.

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Volume 20 Number 7
Apr 1, 2024
Volume 20 Number 7
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