NEJM:冠状动脉疾病的依维莫司洗脱支架或搭桥手术试验

2015-03-17 崔倩译 MedSci原创

背景 大多数比较经皮冠状动脉介入治疗(PCI)和冠状动脉旁路移植术(CABG)的试验没有使用第二代药物洗脱支架。 方法 我们在东亚27个中心进行了一项随机性试验。我们计划随机分配1776例冠状动脉多支病变患者进行依维莫司洗脱支架的经皮冠动脉介入治疗或冠状动脉搭桥术。在随机治疗的2年后主要终点是死亡,心肌梗死,或靶血管血运重建。在长期随访也比较了组间的事件发生率。 结果 880例报名后(438例

背景 大多数比较经皮冠状动脉介入治疗(PCI)和冠状动脉旁路移植术(CABG)的试验没有使用第二代药物洗脱支架。

方法 我们在东亚27个中心进行了一项随机性试验。我们计划随机分配1776例冠状动脉多支病变患者进行依维莫司洗脱支架的经皮冠动脉介入治疗或冠状动脉搭桥术。在随机治疗的2年后主要终点是死亡,心肌梗死,或靶血管血运重建。在长期随访也比较了组间的事件发生率。

结果 880例报名后(438例患者随机分配为PCI组和442例 患者随机分配为CABG组),由于报名人数较少研究被提前终止。在2年的时候,主要终点就PCI组和CABG组发生的概率分别为11%和7.9%(绝对风险差异,3.1个百分点;95%置信区间[CI],−0.8到6.9;P = 0.32非劣效性)。在长期随访(中位数,4.6年),主要终点在PCI组和CABG组发生的概率分别为15.3%和10.6%(风险比,1.47;95% CI,1.01~2.13;P = 0.04)。两组间复合安全终点死亡、心肌梗死、中风的发生无显著差异。然而,任何重复血管重建和自发性心肌梗死的发生率在PCI治疗后显著高于CABG治疗后。

结论 在多支冠状动脉疾病患者中,主要心血管不良事件的发生率在那些接受了使用依维莫司洗脱支架的PCI治疗要高于那些接受了CABG治疗。

原始出处

Seung-Jung Park, M.D., Ph.D., Jung-Min Ahn, M.D., Young-Hak Kim, M.D.et.al.Trial of Everolimus-Eluting Stents or Bypass Surgery for Coronary Disease.NEJM.2015

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