Comparative efficacy and safety of new oral anticoagulants in patients with atrial fibrillation.
Comparative efficacy and safety of new oral anticoagulants in patients with atrial fibrillation.
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DOI：
10.1161/circoutcomes.112.965988
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发表时间：
2012-07-01
期刊：
影响因子：
--
通讯作者：
Avorn J
中科院分区：
文献类型：
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作者：
Schneeweiss S;Gagne JJ;Patrick AR;Choudhry NK;Avorn J
Dabigatran, an oral thrombin inhibitor, and rivaroxaban and apixaban, oral factor Xa inhibitors, have been found safe and effective in reducing stroke risk in patients with atrial fibrillation. We sought to compare the efficacy and safety of the 3 new agents based on data from their published warfarin-controlled randomized trials, using the method of adjusted indirect comparisons. We included findings from 44,535 patients enrolled in three trials of the efficacy of dabigatran (RE-LY), apixaban (ARISTOTLE), and rivaroxaban (ROCKET-AF), each compared with warfarin. The primary efficacy endpoint was stroke or systemic embolism; the safety endpoint we studied was major hemorrhage. To address a lack of comparability between trial populations caused by the restriction of ROCKET-AF to high risk patients, we conducted a subgroup analysis in patients with a CHADS2 score ≥3. We found no statistically significant efficacy differences among the three drugs, although apixaban and dabigatran were numerically superior to rivaroxaban. Apixaban produced significantly fewer major hemorrhages than dabigatran and rivaroxaban. An indirect comparison of new anticoagulants based on existing trial data indicates that in patients with a CHADS2 score ≥3 dabigatran 150mg, apixaban 5mg, and rivaroxaban 20 mg resulted in statistically similar rates of stroke and systemic embolism, but apixaban had a lower risk of major hemorrhage compared to dabigatran and rivaroxaban . Until head-to-head trials or large-scale observational studies that reflect routine use of these agents are available, such adjusted indirect comparisons based on trial data are one tool to guide initial therapeutic choices.
