Three-Year Outcomes With Fractional Flow Reserve-Guided or Angiography-Guided Multivessel Percutaneous Coronary Intervention for Myocardial Infarction.

IF 6.1 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Circulation: Cardiovascular Interventions Pub Date : 2024-06-01 Epub Date: 2024-05-24 DOI:10.1161/CIRCINTERVENTIONS.123.013913

Etienne Puymirat, Guillaume Cayla, Tabassome Simon, Philippe Gabriel Steg, Gilles Montalescot, Isabelle Durand-Zaleski, Fabiola Ngaleu Siaha, Romain Gallet, Khalife Khalife, Jean-François Morelle, Pascal Motreff, Gilles Lemesle, Jean-Guillaume Dillinger, Thibault Lhermusier, Johanne Silvain, Vincent Roule, Jean-Noel Labèque, Grégoire Rangé, Grégory Ducrocq, Yves Cottin, Didier Blanchard, Anaïs Charles Nelson, Juliette Djadi-Prat, Gilles Chatellier, Nicolas Danchin

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Abstract

Background: In patients with multivessel disease with successful primary percutaneous coronary intervention for ST-segment-elevation myocardial infarction, the FLOWER-MI trial (Flow Evaluation to Guide Revascularization in Multivessel ST-Elevation Myocardial Infarction) showed that a fractional flow reserve (FFR)-guided strategy was not superior to an angiography-guided strategy for treatment of noninfarct-related artery lesions regarding the 1-year risk of death from any cause, myocardial infarction, or unplanned hospitalization leading to urgent revascularization. The extension phase of the trial was planned using the same primary outcome to determine whether a difference in outcomes would be observed with a longer follow-up.

Methods: In this multicenter trial, we randomly assigned patients with ST-segment-elevation myocardial infarction and multivessel disease with successful percutaneous coronary intervention of the infarct-related artery to receive complete revascularization guided by either FFR (n=586) or angiography (n=577).

Results: After 3 years, a primary outcome event occurred in 52 of 498 patients (9.40%) in the FFR-guided group and in 44 of 502 patients (8.17%) in the angiography-guided group (hazard ratio, 1.19 [95% CI, 0.79-1.77]; P=0.4). Death occurred in 22 patients (4.00%) in the FFR-guided group and in 23 (4.32%) in the angiography-guided group (hazard ratio, 0.96 [95% CI, 0.53-1.71]); nonfatal myocardial infarction in 23 (4.13%) and 14 (2.56%), respectively (hazard ratio, 1.63 [95% CI, 0.84-3.16]); and unplanned hospitalization leading to urgent revascularization in 21 (3.83%) and 18 (3.36%; hazard ratio, 1.15 [95% CI, 0.61-2.16]), respectively.

Conclusions: Although event rates in the trial were lower than expected, in patients with ST-segment-elevation myocardial infarction undergoing complete revascularization, an FFR-guided strategy did not have a significant benefit over an angiography-guided strategy with respect to the risk of death, myocardial infarction, or urgent revascularization up to 3 years.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02943954.

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分数血流储备引导或血管造影引导的多血管经皮冠状动脉介入治疗心肌梗死的三年疗效。

背景：在成功进行经皮冠状动脉介入治疗 ST 段抬高型心肌梗死的多支血管疾病患者中，FLOWER-MI 试验（Flow Evaluation to Guide Revascularization in Multivessel ST-Elevation Myocardial Infarction）显示，分数血流储备（FFR）引导的策略并不适合多支血管疾病患者、FLOWER-MI试验（多血管ST段抬高型心肌梗死血流评估指导再血管化）显示，在治疗非梗死相关动脉病变的1年风险方面，分数血流储备（FFR）指导策略并不优于血管造影指导策略，前者可降低任何原因导致的死亡、心肌梗死或导致紧急再血管化的意外住院风险。该试验的扩展阶段计划采用相同的主要结果，以确定在更长时间的随访中是否能观察到结果的差异：在这项多中心试验中，我们随机分配了ST段抬高型心肌梗死和多支血管疾病患者，这些患者成功接受了梗死相关动脉的经皮冠状动脉介入治疗，并在FFR（586例）或血管造影（577例）的指导下接受了完全血运重建：3年后，FFR引导组498例患者中有52例（9.40%）发生主要结局事件，血管造影引导组502例患者中有44例（8.17%）发生主要结局事件（危险比为1.19 [95% CI, 0.79-1.77]；P=0.4）。在 FFR 引导组和血管造影引导组中，分别有 22 例（4.00%）和 23 例（4.32%）患者死亡（危险比为 0.96 [95% CI, 0.53-1.71]）；分别有 23 例（4.13%）和 14 例（2.56%）（危险比为 1.63 [95% CI, 0.84-3.16]）；分别有 21 例（3.83%）和 18 例（3.36%；危险比为 1.15 [95% CI, 0.61-2.16]）非计划住院导致紧急血运重建：尽管试验中的事件发生率低于预期，但在接受完全血管重建的ST段抬高型心肌梗死患者中，就死亡、心肌梗死或紧急血管重建的风险而言，FFR指导策略与血管造影指导策略相比在3年内并无明显优势：URL：https://www.clinicaltrials.gov；唯一标识符：NCT02943954。

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来源期刊

Circulation: Cardiovascular Interventions CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

10.30

自引率

1.80%

发文量

221

审稿时长

6-12 weeks

期刊介绍： Circulation: Cardiovascular Interventions, an American Heart Association journal, focuses on interventional techniques pertaining to coronary artery disease, structural heart disease, and vascular disease, with priority placed on original research and on randomized trials and large registry studies. In addition, pharmacological, diagnostic, and pathophysiological aspects of interventional cardiology are given special attention in this online-only journal.