BACKGROUND Complete revascularization in ST elevation myocardial infarction (STEMI) patients with multivessel disease has resulted in reduction in composite clinical endpoints in medium sized trials. Only one trial showed an effect on hard clinical endpoints, but the revascularization procedure was guided by angiographic evaluation of stenosis severity. Consequently, it is not clear how Fractional Flow Reserve (FFR)-guided percutaneous coronary intervention (PCI) affects hard clinical endpoints in STEMI. METHODS AND RESULTS The Ffr-gUidance for compLete non-cuLprit REVASCularization (FULL REVASC) - is a pragmatic, multicenter, international, registry-based randomized clinical trial designed to evaluate whether a strategy of FFR-guided complete revascularization of non-culprit lesions, reduces the combined primary endpoint of total mortality, non-fatal MI and unplanned revascularization. 1,545 patients were randomized to receive FFR-guided PCI during the index hospitalization or initial conservative management of non-culprit lesions. We found that in angiographically severe non-culprit lesions of 90-99% severity, 1 in 5 of these lesions were re-classified as non-flow limiting by FFR. Considering lesions of intermediate severity (70%-89%), half were re-classified as non-flow limiting by FFR. The study is event driven for an estimated follow-up of at least 2.75 years to detect a 9.9%/year>7.425%/year difference (HR = 0.74 at 80% power (α = .05)) for the combined primary endpoint. CONCLUSION This large randomized clinical trial is designed and powered to evaluate the effect of complete revascularization with FFR-guided PCI during index hospitalization on total mortality, non-fatal MI and unplanned revascularization following primary PCI in STEMI patients with multivessel disease. Enrollment completed in September 2019 and follow-up is ongoing.

中文翻译：

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Full Revasc（Ffr-gUidance for compLete non-cuLprit REVASCularization）基于注册的随机临床试验。

背景 在多支血管病变的 ST 段抬高型心肌梗死 (STEMI) 患者中，完全血运重建降低了中型试验的复合临床终点。只有一项试验显示对硬临床终点有影响，但血运重建程序是由血管造影评估狭窄严重程度指导的。因此，尚不清楚分数流量储备 (FFR) 引导的经皮冠状动脉介入治疗 (PCI) 如何影响 STEMI 的硬临床终点。方法和结果 Ffr 指导完整的非罪犯血管重建 (FULL REVASC) - 是一项务实的、多中心的、国际的、基于注册的随机临床试验，旨在评估 FFR 指导的非罪犯病变的完全血运重建策略是否，降低总死亡率的综合主要终点，非致命性心肌梗死和计划外血运重建。1,545 名患者在指数住院期间随机接受 FFR 引导的 PCI 或非罪犯病变的初始保守治疗。我们发现，在严重程度为 90-99% 的血管造影严重非罪魁祸首病变中，这些病变中有五分之一被 FFR 重新分类为非流量限制。考虑到中等严重程度的病变（70%-89%），一半被 FFR 重新分类为非流量限制。该研究是事件驱动的，估计随访至少 2.75 年，以检测联合主要终点的 9.9%/年>7.425%/年差异（HR = 0.74，80% 功效 (α = .05)）。结论 这项大型随机临床试验旨在评估首次住院期间采用 FFR 引导的 PCI 完全血运重建对总死亡率的影响，多支血管病变 STEMI 患者直接 PCI 后的非致死性 MI 和计划外血运重建。注册于 2019 年 9 月完成，后续工作正在进行中。