Abstract | BACKGROUND: 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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Authors | Takashi Noda, Kotaro Nochioka, Koichi Kaikita, Masaharu Akao, Junya Ako, Tetsuya Matoba, Masato Nakamura, Katsumi Miyauchi, Nobuhisa Hagiwara, Kazuo Kimura, Atsushi Hirayama, Kunihiko Matsui, Hisao Ogawa, Satoshi Yasuda, On Behalf Of The Afire Investigators |
Journal | EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
(EuroIntervention)
Vol. 20
Issue 7
Pg. e425-e435
(Apr 01 2024)
ISSN: 1969-6213 [Electronic] France |
PMID | 38562065
(Publication Type: Clinical Trial, Journal Article)
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Chemical References |
- Anticoagulants
- Fibrinolytic Agents
- Platelet Aggregation Inhibitors
- Rivaroxaban
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Topics |
- Humans
- Anticoagulants
- Atrial Fibrillation
(complications, drug therapy)
- Coronary Artery Disease
(complications, drug therapy)
- Fibrinolytic Agents
(therapeutic use)
- Hemorrhage
(chemically induced)
- Platelet Aggregation Inhibitors
- Rivaroxaban
- Stroke
(etiology, prevention & control)
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