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Title: Efficacy and safety of oral direct factor Xa inhibitors versus warfarin in patients with atrial fibrillation: a meta-analysis of randomized controlled trials
Author(s): C.-L. Xiang , Y.-Z. Gong , L.-J. Zeng , R. Wang , S. Kea , N. Chaudhary , R.-H. Tu , Y. He
Journal: Acta Cardiologica
Volume: 71 Issue: 3 Date: 2016
Objective: Oral direct factor Xa inhibitors, a new class of anticoagulants, have emerged as an alternative to warfarin in patients with atrial fibrillation (AF). We aimed to assess the effects of oral direct factor Xa inhibitors versus warfarin on ischaemic and bleeding outcomes.
Methods and results: We searched PubMed, Embase, and the Cochrane Central Register of Controlled Trials for randomized controlled trials comparing oral direct factor Xa inhibitors with warfarin in patients with AF. The primary efficacy outcome was the composite end point of strokes and other systemic embolic events. The primary safety outcome was major bleeding. We calculated pooled relative risks (RRs) and 95% Cis using random-effects model. We included 9 trials involving 57,497 patients. Compared with warfarin, oral direct factor Xa inhibitors were associated with an 18% reduction in strokes and other systemic embolic events (RR: 0.82; 95% CI: 0.69-0.99; P = 0.04), mainly driven by a reduction in haemorrhagic stroke (RR: 0.49; 95% CI: 0.40-0.60; P < 0.00001). Oral direct factor Xa inhibitors also significantly reduced all-cause mortality (RR: 0.89; 95% CI: 0.84-0.95; P = 0.0002) and intracranial haemorrhage (RR: 0.47; 95% CI: 0.37-0.59; P < 0.00001). Oral direct factor Xa inhibitors lowered the risk of major bleeding events by 25% compared with warfarin (RR: 0.75; 95% CI: 0.58-0.97; P = 0.03).
Conclusions: In patients with AF, oral direct factor Xa inhibitors conferred favourable benefit and risk profiles, with significant reductions in strokes and systemic embolic events, haemorrhagic stroke, mortality, major bleeding, and intracranial haemorrhage when compared with warfarin.