NEJM:搭桥 or 支架?冠心病患者的选择因病情而异!

2021-11-14 MedSci原创 MedSci原创

在三血管冠状动脉疾病患者中,就死亡、心肌梗死、中风或1年后重复血管治疗的发生率而言,FFR引导下的PCI并不劣于CABG。

根据美国心脏协会(AHA)的数据,在美国,60岁以上的人中有40%患有冠状动脉狭窄。《中国血管健康与疾病报告》数据显示,在中国,冠心病患者约有1139万。大多数患者可以用他汀类药物或阿司匹林治疗,而狭窄严重者则需要进行血运重建:经皮冠状动脉介入术(PCI)或者冠状动脉旁路移植术(CABG)。

目前有报道称三血管冠状动脉疾病患者采用CABG比采用PCI的效果更好,但一直缺乏通过测量分数流量储备(FFR)指导PCI的研究。为此,来自斯坦福大学心血管研究所的专家开展了一项名为FAME3的研究,结果发表在NEJM杂志上。

在这项多中心的国际非劣效试验中,三血管冠状动脉疾病患者被随机分配接受CABG或在FFR指导下使用当前一代佐他莫司洗脱支架进行PCI。主要终点是在1年内发生主要的心脏或脑血管不良事件,定义为任何原因导致的死亡、心肌梗死、中风或重复血管再造。预先规定FFR引导下的PCI对CABG的非劣效性,即危险比的95%置信区间的上限小于1.65。次要终点包括死亡、心肌梗死或中风的综合指标;还评估了安全性。

最终共有1500名患者在48个中心接受了随机分组。被指定接受PCI的患者平均(±SD)接受了3.7±1.9个支架,而被指定接受CABG的患者接受了3.4±1.0个远端吻合术。在随机分配接受FFR引导的PCI的患者中,复合主要终点的1年发生率为10.6%,在分配接受CABG的患者中为6.9%,PCI术患者的风险增加50%(HR=1.5;95%CI:1.1-2.2),搭桥相比,基于FFR进行支架植入的治疗效果未达到非劣效性(非劣效性的P=0.35)。

PCI与CABG两组患者在随访期间主要终点事件发生差异

FFR引导下的PCI组死亡、心肌梗死或中风的发生率为7.3%,CABG组为5.2%,PCI的风险增加40%(HR=1.4;95%CI,0.9-2.1)。CABG组的大出血、心律失常和急性肾脏损伤的发生率高于FFR引导的PCI组。

综上,在三血管冠状动脉疾病患者中,就死亡、心肌梗死、中风或1年后重复血管治疗的发生率而言,FFR引导下的PCI并不劣于CABG。

 

参考文献:

Fractional Flow Reserve–Guided PCI as Compared with Coronary Bypass Surgery. November 4, 2021. DOI: 10.1056/NEJMoa2112299

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