ACC2011:在有不同类型的房颤患者中比较达比加群酯与华法林:一项RE-LY亚组分析

2011-05-07 MedSci原创 MedSci原创

  背景:RE-LY试验将18 113例有房颤和至少有一项卒中危险因素的患者随机分配接受达比加群酯(110 mg或150 mg,bid)或调整剂量的华法林。  方法:来自RE-LY试验的一项亚组分析在有不同类型的房颤患者中评估了与华法林相比达比加群酯的有效性和安全性。  结果:共有18 107例患者有房颤类型的详情;6375例为永久性房颤,5943例为阵发性房颤,5789例为持续性房颤。在永久性房

  背景:RE-LY试验将18 113例有房颤和至少有一项卒中危险因素的患者随机分配接受达比加群酯(110 mg或150 mg,bid)或调整剂量的华法林。
  方法:来自RE-LY试验的一项亚组分析在有不同类型的房颤患者中评估了与华法林相比达比加群酯的有效性和安全性。
  结果:共有18 107例患者有房颤类型的详情;6375例为永久性房颤,5943例为阵发性房颤,5789例为持续性房颤。在永久性房颤患者中,达比加群酯110 mg bid组、达比加群酯150 mg bid组和华法林组卒中/体循环栓塞的发生率(%/年)为1.78%、1.11%和1.58%;在阵发性房颤患者中,分别为1.07%、1.09%和 1.77%;在持续性房颤患者中,则分别为1.72%、1.14%和1.80%。各房颤类型中达比加群酯150 mg bid均较华法林更为有效(永久性房颤:HR 0.70,95%CI:0.48~1.01;阵发性房颤:HR 0.61,95%CI:0.42~0.90;持续性房颤:HR 0.64,95%CI:0.43~0.93),而达比加群酯110 mg bid显示出与华法林相似的有效性(分别为1.13「0.81~1.57」 、0.60「0.41~0.89」和0.96「0.69~1.35」),交互P=0.16。在永久性房颤中,达比加群酯110 mg bid组、达比加群酯150 mg bid组和华法林组大出血事件(MBE)的发生率分别为2.74%、3.07%和2.96%;在阵发性房颤中,分别为3.05%、3.74%和 3.91%;在持续性房颤中,分别为2.87%、3.14%和3.88%,交互 P=0.58。
  结论:与RE-LY试验的整体结果一致,达比加群酯150 mg bid与华法林相比,对卒中或体循环栓塞预防的有效性改善,且达比加群酯110 mg bid大出血发生率较低,无论卒中类型如何。

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