Background: Warfarin, despite its known limitations, is the reference standard treatment for patients with AFand risk factors for stroke. We performed a meta-analysis of phase III trials that compare novel oral anticoagulants(NOACs) with warfarin to determine whether they improve clinical outcomes of patients with nonvalvularatrial fibrillation (AF).Methods: Three randomized trials that compared NOACs with warfarin in AF were selected. The primary efficacyendpoint was the incidence of stroke or systemic embolism. The primary safety endpoint was the incidenceof major bleeding.Results: A total of 50578 patients were included. NOACs significantly decreased stroke or systemic embolism(2.8% vs 3.5%, odds ratio [OR] 0.82, 95% confidence interval [CI] 0.74–0.91, Pb0.001), death (6.0% vs 6.3%, OR0.88, 95% CI 0.82–0.95, P=0.001) and stroke (2.4% vs 3.0%, OR 0.79, 95% CI 0.71–0.88, Pb0.001). The reductionin stroke was mainly driven by fewer hemorrhagic strokes (0.3% vs 0.8%, OR 0.79, 95% CI 0.71–0.88,Pb0.001). Major bleeding occurred in 5.0% and 5.6% of patients in the NOACs and warfarin groups (OR0.85, 95% CI 0.69–1.05, P=0.14 in the random-effects model). NOACs were associated with lower rates of intracranialbleeding (0.6% vs 1.3%, Pb0.001) and higher rates of gastrointestinal bleeding (2.3% vs 1.3%,P=0.036).Conclusions: In patients with non-valvular AF, NOACs decrease stroke or systemic embolism, hemorrhagicstroke and mortality, with similar risk of major bleeding compared to warfarin.
Novel oral anticoagulants versus warfarin in non-valvular atrial fibrillation: A meta-analysis of 50,578 patients
CAPODANNO, DAVIDE FRANCESCO MARIA;CAPRANZANO P.;CALVI, Valeria IliaPenultimo
Conceptualization
;TAMBURINO, Corrado
2013-01-01
Abstract
Background: Warfarin, despite its known limitations, is the reference standard treatment for patients with AFand risk factors for stroke. We performed a meta-analysis of phase III trials that compare novel oral anticoagulants(NOACs) with warfarin to determine whether they improve clinical outcomes of patients with nonvalvularatrial fibrillation (AF).Methods: Three randomized trials that compared NOACs with warfarin in AF were selected. The primary efficacyendpoint was the incidence of stroke or systemic embolism. The primary safety endpoint was the incidenceof major bleeding.Results: A total of 50578 patients were included. NOACs significantly decreased stroke or systemic embolism(2.8% vs 3.5%, odds ratio [OR] 0.82, 95% confidence interval [CI] 0.74–0.91, Pb0.001), death (6.0% vs 6.3%, OR0.88, 95% CI 0.82–0.95, P=0.001) and stroke (2.4% vs 3.0%, OR 0.79, 95% CI 0.71–0.88, Pb0.001). The reductionin stroke was mainly driven by fewer hemorrhagic strokes (0.3% vs 0.8%, OR 0.79, 95% CI 0.71–0.88,Pb0.001). Major bleeding occurred in 5.0% and 5.6% of patients in the NOACs and warfarin groups (OR0.85, 95% CI 0.69–1.05, P=0.14 in the random-effects model). NOACs were associated with lower rates of intracranialbleeding (0.6% vs 1.3%, Pb0.001) and higher rates of gastrointestinal bleeding (2.3% vs 1.3%,P=0.036).Conclusions: In patients with non-valvular AF, NOACs decrease stroke or systemic embolism, hemorrhagicstroke and mortality, with similar risk of major bleeding compared to warfarin.File | Dimensione | Formato | |
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Novel oral anticoagulants versus warfarin in non-valvular atrial fibrillation Int J Cardiol 2012.pdf
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