Smits Pieter C, Assaf Amira, Richardt Gert, Omerovic Elmir, Abdel-Wahab Mohamed, Neumann Franz-Joseph
Maasstad Ziekenhuis, Rotterdam, the Netherlands.
Maasstad Ziekenhuis, Rotterdam, the Netherlands.
Am Heart J. 2017 Apr;186:21-28. doi: 10.1016/j.ahj.2016.12.016. Epub 2017 Jan 5.
What the best strategy is for nonculprit lesions in ST-elevation myocardial infarction (STEMI) patients presenting with multivessel disease remains a clinical dilemma. Based on recent clinical studies suggesting that complete revascularization in the acute phase is beneficial, the European Society of Cardiology and American College of Cardiology/American Heart Association guidelines have been recently changed from class 3 discouragement to a class 2B recommendation concerning the treatment of the nonculprit lesions in the acute index procedure. However, in these recent studies, nonculprit lesion treatment was guided by angiography, which is known for its poor accuracy in determining ischemia. Fractional flow reserve (FFR) guidance for treatment of nonculprit vessels seems to be a reasonable approach, and in the acute setting of STEMI, it is not yet investigated. The COMPARE-ACUTE trial aims to investigate FFR-guided complete revascularization in comparison to a culprit lesion treatment-only strategy in STEMI patients with multivessel disease presenting for primary percutaneous coronary intervention.
COMPARE-ACUTE is an investigator-initiated, prospective multicenter randomized controlled trial. After successful primary percutaneous coronary intervention, patients will be randomized in a 1:2 fashion toward FFR-guided complete revascularization or culprit lesion treatment-only strategies. The chosen primary end point is a composite of all-cause mortality, nonfatal myocardial infarction, any revascularization, and cerebrovascular events (major adverse cardiac and cerebrovascular events) at 12 months, with 3-year follow-up. Based on estimated event rates, a sample size of 885 patients is needed to show superiority of the FFR-guided revascularization with 80% power.
The aim of the COMPARE-ACUTE trial is to assess whether FFR-guided complete revascularization in the acute setting is superior to culprit lesion treatment-only therapy.
对于患有多支血管病变的ST段抬高型心肌梗死（STEMI）患者，非罪犯病变的最佳治疗策略仍是一个临床难题。基于近期临床研究表明急性期完全血运重建有益，欧洲心脏病学会和美国心脏病学会/美国心脏协会的指南最近已从3类不推荐改为2B类推荐，涉及在急性首次手术中对非罪犯病变的治疗。然而，在这些近期研究中，非罪犯病变治疗是由血管造影引导的，而血管造影在确定缺血方面准确性较差。采用血流储备分数（FFR）指导非罪犯血管的治疗似乎是一种合理的方法，而在STEMI的急性期，尚未对此进行研究。COMPARE - ACUTE试验旨在研究在接受直接经皮冠状动脉介入治疗的多支血管病变STEMI患者中，与仅治疗罪犯病变策略相比，FFR指导下的完全血运重建情况。
COMPARE - ACUTE是一项由研究者发起的前瞻性多中心随机对照试验。在成功进行直接经皮冠状动脉介入治疗后，患者将以1:2的比例随机分为FFR指导下的完全血运重建组或仅治疗罪犯病变策略组。选定的主要终点是12个月时全因死亡率、非致命性心肌梗死、任何血运重建以及脑血管事件（主要不良心脑血管事件）的复合终点，并进行3年随访。根据估计的事件发生率，需要885例患者的样本量才能以80%的检验效能显示FFR指导下血运重建的优越性。
COMPARE - ACUTE试验的目的是评估在急性期FFR指导下的完全血运重建是否优于仅治疗罪犯病变的疗法。
