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Background  The original non–vitamin K antagonist oral anticoagulant ( NOAC ) trials in nonvalvular atrial fibrillation ( AF ) enrolled patients with native valve pathologies. The object of this study was to quantify the benefit–risk profiles of  NOAC s versus warfarin in  AF  patients with native valvular heart disease ( VHD ).    Methods and Results  Trials were identified by exhaustive literature search. Trial data were combined using inverse variance weighting to produce a meta‐analytic summary hazard ratio ( HR ) and 95% confidence interval ( CI ) of efficacy and safety of  NOAC s versus warfarin. Our final analysis included 4 randomized controlled trials that enrolled 71 526 participants, including 13 574 with  VHD . Pooling results from included trials showed that  NOAC s versus warfarin reduced stroke or systemic embolism ( HR : 0.70; 95%  CI , 0.60–0.82) and intracranial hemorrhage ( HR : 0.47; 95%  CI , 0.24–0.92) in  AF  patients with  VHD . However, risk reduction of major bleeding and intracranial hemorrhage was driven by apixaban, edoxaban, and dabigatran (HR for major bleeding: 0.79 [95%  CI , 0.69–0.91]; HR for intracranial hemorrhage: 0.33 [95%  CI , 0.25–0.45]) but not rivaroxaban (HR for major bleeding: 1.56 [95%  CI , 1.20–2.04]; HR for intracranial hemorrhage: 1.27 [95%  CI , 0.77–2.10]).    Conclusions  Among patients with  AF  and native  VHD ,  NOAC s reduce stroke and systemic embolism compared with warfarin. Evidence shows that apixaban, dabigatran, and edoxaban also reduce bleeding in this patient subgroup, whereas major bleeding (but not intracranial hemorrhage or mortality rate) is significantly increased in  VHD  patients treated with rivaroxaban.  NOAC s are a reasonable alternative to warfarin in  AF  patients with  VHD .

journal of the american heart association

Effects of Non–Vitamin K Antagonist Oral Anticoagulants Versus Warfarin in Patients With Atrial Fibrillation and Valvular Heart Disease: A Systematic Review and Meta‐Analysis