NEJM:STEMI多支血管完全血运重建获益(COMPLETE研究)

2019-12-11 周玉杰 严道医生

作者:北京安贞医院周玉杰团队 娄亚柯 高雅楠 刘巍 急诊PCI广泛应用于ST段抬高型心肌梗死(STEMI)患者的再灌注治疗中。STEMI患者往往存在多支血管病变,研究已经证实对STEMI患者的罪犯病变行PCI治疗可以降低心血管死亡率和心肌梗死再发风险。然而,对于非罪犯病变是否需要处理目前尚无定论,非罪犯病变PCI治疗能否进一步降低远期不良事件发生风险目前也仍未可知。COMPL

作者:北京安贞医院周玉杰团队 娄亚柯 高雅楠 刘巍


急诊PCI广泛应用于ST段抬高型心肌梗死(STEMI)患者的再灌注治疗中。STEMI患者往往存在多支血管病变,研究已经证实对STEMI患者的罪犯病变行PCI治疗可以降低心血管死亡率和心肌梗死再发风险。然而,对于非罪犯病变是否需要处理目前尚无定论,非罪犯病变PCI治疗能否进一步降低远期不良事件发生风险目前也仍未可知。COMPLETE研究的出现填补了这一空缺。

研究简介:

COMPLETE研究为大规模、多中心、随机对照试验,以多支病变的STEMI患者为研究对象,根据非罪犯病变是否进一步处理随机分组,分为完全血运重建组和仅罪犯病变PCI组,所有患者均在急诊PCI治疗后的72h内完成随机分组。复合主要终点事件包括心血管性死亡和心肌梗死,次要终点事件由心血管性死亡、心肌梗死和缺血所致血运重建共同构成。

最终,该研究累计纳入4041名患者,其中完全血运重建组2016名患者,仅罪犯病变PCI组2025名患者;平均随访3年,完全血运重建组有158(7.8%)名患者发生了主要终点事件,仅罪犯病变PCI组则有213(10.5%)名患者发生了主要终点事件,且差异具有统计学意义(HR 0.74;95% CI 0.60-0.91,P=0.004),这一差异主要来源于心肌梗死再发率(5.4% vs. 7.9%; HR, 0.68; 95% CI, 0.53 to 0.86)。在次要终点事件发生率方面,完全血运重建组同样具有较低的发生率(8.9% vs 16.7%;HR 0.51;95% CI 0.43-0.61;P<0.001)。

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根据完成非罪犯病变PCI的时间进行亚组分析发现,无论是在本次住院期间完成非罪犯病变PCI还是出院后择期完成非罪犯病变PCI,完全血运重建均可带来获益。

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因此,对于存在多支血管病变的STEMI患者来说,无论是在降低主要终点事件(心血管性死亡率和再发心肌梗死)还是次要终点事件(心血管性死亡率,再发心肌梗死,缺血所致血运重建)方面,完全血运重建显著优于仅对罪犯病变行PCI治疗。

关于COMPLETE研究,专家怎么看?

超过一半的STEMI患者为多支血管病变,ACC/AHA指南将非罪犯病变治疗列为IIb类推荐。一些中等规模试验已经证实完全血运重建是安全的,并可以降低再次血运重建率。但是到目前为止,还未证实完全血运重建可以降低死亡、再次心梗等硬终点事件的发生率。此外,目前有观点指出非罪犯病变的血运重建应基于血流储备分数(FFR)。

本次ESC 2019会议上公布的大规模随机对照试验COMPLETE研究显示,相比仅罪犯病变PCI组,完全血运重建组主要终点事件发生率下降了近1/4,这种差异主要来源于新发心肌梗死率的下降,而两组心血管性死亡率(2.9% vs 3.2%)和全因死亡率(4.8% vs 5.25)并无显著差异。此外,完全血运重建组次要终点事件发生率相比近罪犯病变PCI组也下降了50%。对于随机分组至完全血运重建组的患者,1/3的患者在出院后择期完成了第二次PCI。根据第二次PCI时间进行亚组分析后主要终点事件发生率方面并未显示出变化,这提示着,对于某些患者来说,即使将非罪犯病变PCI推迟至出院后择期完成也依然是安全的。同时,两组患者不良事件(包括卒中,主要出血事件,急性肾损伤)发生率相似,为二次手术的安全性提供了证据。

相比既往研究,COMPLETE研究的意义体现在哪里?

对比COMPLETE研究与既往其它研究,尽管COMPLETE研究的患者年龄和性别分布与其他研究相似,但COMPLETE研究的主要结局终点事件发生率低于其它研究而不良事件发生例数则多于其它研究,提示着样本量和长期随访的重要性。

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非罪犯病变的功能学评价——FFR是否必需?

COMPLETE研究中,几乎所有非罪犯病变是通过冠脉造影发现的,其中60%狭窄程度≥80%,38%位于LAD。因此,大多病变在冠脉造影上是存在显著异常的,而对于那些中等狭窄程度的病变,FFR则具有重要价值。

COMPLETE及既往一系列随机对照研究的结果能否改变当前指南关于多支血管病变STEMI患者的血运重建推荐?

研究入选的患者与临床中病情较重的患者还是存在差异的,盲目将结果扩展至具有更高并发症风险的患者并不安全。COMPLETE研究的患者平均SYNTAX评分为相对较低,相应的,成功完全血运重建机会也更大。而那些非罪犯病变为复杂病变(SYNTAX评分较高)的患者可能并不适合这样的常规治疗。此外,还有一部分患者可以通过强效双抗治疗(普拉格雷或替格瑞洛)获益。而COMPLETE研究中,1/4的患者服用了氯吡格雷,抗栓效果并未达到最大化。

完全血运重建并未在全因死亡率方面带来获益,这是否会引起对完全血运重建策略的质疑?

就目前的证据而言,完全血运重建是安全的,同时可以降低心血管死亡和再次心梗组成的复合终点事件发生率,因此对于临床特征与COMPLETE研究入选对象相似的患者,可以考虑进行完全血运重建。当然,我们也希望研究者将随访继续下去,进而判断在更远的将来两组患者的全因死亡率是否会随着时间的推移而产生差异。更好的识别出高风险患者也可以进一步明确哪些患者更有可能从完全血运重建中得到获益。无论如何,根据COMPLETE研究的结果,指南应该对多支血管的STEMI患者、至少是在那些非罪犯病变适合PCI的患者中,进行完全血运重建提出相关建议。

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    2020-05-26 lg.zhao
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    2020-07-01 xuyong536
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    2019-12-11 旺医

    顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息

    0

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