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首页> 外文期刊>Clinical cardiology. >Efficacy and safety of apixaban vs warfarin in patients with atrial fibrillation and prior bioprosthetic valve replacement or valve repair: Insights from the ARISTOTLE trial
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Efficacy and safety of apixaban vs warfarin in patients with atrial fibrillation and prior bioprosthetic valve replacement or valve repair: Insights from the ARISTOTLE trial

机译：阿哌沙班与华法林对房颤并事先进行生物人工瓣膜置换或瓣膜修复的患者的疗效和安全性：ARISTOTLE试验的见解

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Background The optimal anticoagulation strategy for patients with atrial fibrillation (AF) and bioprosthetic valve (BPV) replacement or native valve repair remains uncertain. Hypothesis We evaluated the safety and efficacy of apixaban vs warfarin in patients with AF and a history of BPV replacement or native valve repair. Methods Using data from Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) (n?=?18?201), a randomized trial comparing apixaban with warfarin in patients with AF, we analyzed the subgroup of patients (n?=?251) with prior valve surgery. We contacted sites by telephone to obtain additional data about prior valve surgery. Full data were available for 156 patients. The primary efficacy endpoint was stroke/systemic embolism. The primary safety endpoint was major bleeding. Treatment groups were compared using a Cox regression model. Results In ARISTOTLE, 104 (0.6%) patients had a history of BPV replacement (n?=?73 [aortic], n?=?26 [mitral], n?=?5 [mitral and aortic]) and 52 (0.3%) had a history of valve repair (n?=?50 [mitral], n?=?2 [aortic]). Among patients with BPVs, 55 were randomized to apixaban and 49 to warfarin. Among those with a history of native valve repair, 32 were randomized to apixaban and 20 to warfarin. Overall clinical event rates were low, with no significant differences between apixaban and warfarin for any outcomes. Conclusions In patients with AF and a history of BPV replacement or repair, the safety and efficacy of apixaban compared with warfarin was consistent with results from ARISTOTLE. These data suggest that apixaban may be reasonable for patients with BPVs or prior valve repair, though future larger randomized trials are needed. ClinicalTrials.gov NCT00412984.
机译：背景技术对于房颤（AF）和生物人工瓣膜（BPV）置换或自然瓣膜修复的患者，最佳抗凝策略尚不确定。假设我们评估了阿哌沙班与华法林在房颤患者中的安全性和有效性，并有BPV置换或天然瓣膜修复史。方法使用来自阿哌沙班减少房颤的卒中和其他血栓栓塞事件的数据（ARISTOTLE）（n = 18？201），这是一项将阿哌沙班与华法林用于房颤患者的随机试验，我们分析了患者亚组（n？ =？251），且必须先行瓣膜手术。我们通过电话联系站点，以获得有关先前瓣膜手术的其他数据。有156位患者的完整数据。主要功效终点为中风/全身性栓塞。主要安全终点为大出血。使用Cox回归模型比较治疗组。结果在ARISTOTLE中，有104名（0.6％）患者有BPV置换史（n？=？73 [主动脉]，n？=？26 [双侧]，n？=？5 [双侧和主动脉]）和52（0.3 ％）有瓣膜修复史（n？=？50 [mital]，n？=？2 [主动脉]）。在BPV患者中，有55人被随机分配给阿哌沙班，有49人被分配给华法林。在那些具有天然瓣膜修复史的患者中，有32人被随机分配给阿哌沙班，有20人被分配给华法林。总体临床事件发生率较低，对于任何结果，阿哌沙班和华法林之间均无显着差异。结论对于有房颤且有BPV置换或修复史的患者，阿哌沙班与华法林相比的安全性和有效性与ARISTOTLE的结果一致。这些数据表明阿哌沙班对于BPV或既往瓣膜修复的患者可能是合理的，尽管还需要未来更大的随机试验。 ClinicalTrials.gov NCT00412984。

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