However, there was a nonsignificant trend toward milder presentation and course in the edoxaban group. 22 Overall A meta-analysis pooling the results of all four pivotal clinical trials in patients with NVAF (RE-LY, ROCKET AF, ARISTOTLE, and ENGAGE AF-TIMI 48) included 42,411 patients receiving a DOAC and 29,272 patients receiving a VKA. 23 DOACs had a nonsignificant reduction in rates of major bleeding overall (HR 0.86; 95% CI 0.73–1.00; P =0.06) with significant reductions in hemorrhagic stroke (HR 0.49; 95% CI 0.38–0.64; P <0.0001) and intracranial hemorrhage (HR 0.49; 95% CI 0.39–0.59; P <0.0001) compared to VKA.
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