Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Européen Georges Pompidou, Department of Cardiology, Paris, France; Université Paris-Descartes, 75006 Paris, France; French Alliance for Cardiovascular Trials (FACT), France.
French Alliance for Cardiovascular Trials (FACT), France; AP-HP, Hôpital Saint Antoine, Department of Clinical Pharmacology and Unité de Recherche Clinique (URCEST), Paris, France; Université Pierre et Marie Curie (UPMC-Paris 06), INSERM U-698, Paris, France.
Am Heart J. 2020 Apr;222:1-7. doi: 10.1016/j.ahj.2019.12.015. Epub 2019 Dec 27.
In ST-elevation myocardial infarction (STEMI) patients presenting with multivessel disease (MVD), recent studies have demonstrated the superiority of fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) for non-culprit lesions compared to culprit lesion treatment-only therapy. FFR- and angio-guided PCI have however never been compared in STEMI patients.
FLOWER-MI is an open-label multicenter national randomized clinical trial. The aim is to investigate FFR-guided complete revascularization in comparison to angio-guided complete revascularization in STEMI patients with successful PCI of the culprit lesion and ≥50% stenosis in at least one additional non-culprit lesion requiring PCI. Eligible patients will be randomized after successful primary PCI in a 1:1 fashion to either FFR-guided or angio-guided complete revascularization during the index procedure or a staged procedure before discharge (≤5 days). Patients assigned to FFR guidance first have FFR measured in each non-culprit vessel and only undergo PCI if FFR is ≤0.80. The primary end point of the study is a composite of major adverse cardiac events, including all-cause death, non-fatal MI, and unplanned hospitalization leading to urgent revascularization at 1 year. Secondary end points will include the individual adverse events, cost-effectiveness, quality of life, and 30-day, 6-month, and 3-year outcomes. Based on estimated event rates, a sample size of 1170 patients is needed to show superiority of the FFR-guided revascularization with 80% power.
The aim of FLOWER-MI trial is to assess whether FFR-guided complete revascularization in the acute setting is superior angio-guided complete revascularization.
在多支血管病变（MVD）的 ST 段抬高型心肌梗死（STEMI）患者中，最近的研究表明，与仅处理罪犯病变相比，血流储备分数（FFR）指导的经皮冠状动脉介入治疗（PCI）对非罪犯病变具有优越性。然而，在 STEMI 患者中，FFR 和血管造影指导的 PCI 从未进行过比较。
FLOWER-MI 是一项开放标签的多中心全国性随机临床试验。该研究旨在比较 FFR 指导的完全血运重建与血管造影指导的完全血运重建在成功进行罪犯病变 PCI 且至少有一条需要 PCI 的额外非罪犯病变狭窄≥50%的 STEMI 患者中的疗效。在成功进行原发性 PCI 后，符合条件的患者将以 1:1 的比例随机分配至 FFR 指导或血管造影指导的完全血运重建，在指数操作中或在出院前（≤5 天）进行分期操作。分配到 FFR 指导的患者首先在每个非罪犯血管中测量 FFR，如果 FFR≤0.80，则仅进行 PCI。该研究的主要终点是主要不良心脏事件的复合终点，包括全因死亡、非致死性心肌梗死和导致紧急血运重建的计划外住院，在 1 年时发生。次要终点将包括个别不良事件、成本效益、生活质量以及 30 天、6 个月和 3 年的结局。根据估计的事件发生率，需要 1170 例患者的样本量才能显示 80%的效力下 FFR 指导的血运重建具有优越性。
FLOWER-MI 试验的目的是评估在急性情况下，FFR 指导的完全血运重建是否优于血管造影指导的完全血运重建。
