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
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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DOI：
10.1002/clc.23178
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发表时间：
2019-05-01
影响因子：
2.7
通讯作者：
Granger, Christopher B.
中科院分区：
文献类型：
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作者：
Guimaraes, Patricia O.;Pokorney, Sean D.;Granger, Christopher B.
背景房颤（AF）和生物瓣膜（BPV）置换术或自体瓣膜修复术患者的最佳抗凝策略仍不确定。假设我们评估了阿哌沙班与华法林在有BPV置换或自体瓣膜修复史的AF患者中的安全性和有效性。方法使用来自阿哌沙班减少房颤患者卒中和其他血栓栓塞事件（ARISTOTLE）（n = 18 201）的数据，一项比较阿哌沙班与华法林治疗房颤患者的随机试验，我们分析了既往瓣膜手术的患者亚组（n = 251）。我们通过电话联系了研究中心，以获取有关既往瓣膜手术的更多数据。156例患者的完整数据可用。主要疗效终点为卒中/全身性栓塞。主要安全性终点为大出血。使用考克斯回归模型比较治疗组。结果在ARISTOTLE中，104例（0.6%）患者有BPV置换史（n = 73 [主动脉瓣]，n = 26 [二尖瓣]，n = 5 [二尖瓣和主动脉瓣]），52例（0.3%）有瓣膜修复史（n = 50 [二尖瓣]，n = 2 [主动脉瓣]）。在BPV患者中，55例随机接受阿哌沙班治疗，49例接受华法林治疗。在有自体瓣膜修复史的患者中，32例随机分配至阿哌沙班组，20例随机分配至华法林组。总体临床事件发生率较低，阿哌沙班和华法林之间的任何结局均无显著差异。结论在有BPV置换或修复史的AF患者中，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，阿哌沙班可能是合理的患者与BPVs或以前的瓣膜修复，但未来更大的随机试验是必要的。ClinicalTrials.gov NCT 00412984。
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.