West of Scotland Regional Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK.
Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.
Clin Cardiol. 2020 May;43(5):414-422. doi: 10.1002/clc.23342. Epub 2020 Feb 10.
Post-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) ≥0.90 confers an improved cardiac prognosis. There are currently limited data available to determine how often it is possible to improve an angiographically acceptable but physiologically suboptimal result. A physiology-guided optimization strategy can achieve a clinically meaningful increase in the proportion of patients achieving a final post-PCI FFR ≥0.90 compared to standard care. Following angiographically successful PCI procedures, 260 patients will be randomized (1:1) to receive either a physiology-guided incremental optimization strategy (intervention group) or blinded post-PCI coronary physiology measurements (control group). Patients undergoing successful, standard-of-care PCI for either stable angina or non-ST-segment-elevation myocardial infarction who meet the study's inclusion and exclusion criteria will be eligible for randomization. The primary endpoint is defined as the proportion of patients with a final post-PCI FFR result ≥0.90. Secondary endpoints include change from baseline in Seattle Angina Questionnaire and EQ-5D-5L scores at 3 months and the rate of target vessel failure and its components (cardiac death, myocardial infarction, stent thrombosis, unplanned rehospitalization with target vessel revascularization) at 3 months and 1 year. 260 individual patients were successfully randomized between March 2018 and November 2019. Key baseline demographics of the study population are reported within. TARGET FFR is an investigator-initiated, prospective, single-center, randomized controlled trial of an FFR-guided PCI optimization strategy. The study has completed recruitment and is now in clinical follow-up. It is anticipated that primary results will be presented in Autumn 2020. ClinicalTrials.gov Identifier: NCT03259815. [Correction added on Apr 3 2020, after first online publication: Clinical Trials identifier added.].
经皮冠状动脉介入治疗（PCI）后血流储备分数（FFR）≥0.90 可改善心脏预后。目前，可用的数据有限，无法确定有多少次可能改善血管造影可接受但生理上不理想的结果。与标准治疗相比，生理学指导的优化策略可以使达到最终 PCI 后 FFR≥0.90 的患者比例有临床意义的增加。在血管造影成功的 PCI 手术后，260 名患者将被随机分为（1:1）接受生理学指导的增量优化策略（干预组）或接受盲法 PCI 后冠状动脉生理学测量（对照组）。符合研究纳入和排除标准、成功接受标准护理 PCI 治疗稳定型心绞痛或非 ST 段抬高型心肌梗死的患者有资格进行随机分组。主要终点定义为最终 PCI 后 FFR 结果≥0.90 的患者比例。次要终点包括西雅图心绞痛问卷和 EQ-5D-5L 评分在 3 个月时的基线变化，以及 3 个月和 1 年时靶血管失败及其组成部分（心脏死亡、心肌梗死、支架血栓形成、计划外因靶血管血运重建而再次住院）的发生率。2018 年 3 月至 2019 年 11 月期间，成功对 260 名患者进行了随机分组。报告了研究人群的关键基线人口统计学数据。TARGET FFR 是一项由研究者发起的、前瞻性的、单中心、随机对照试验，旨在评估 FFR 指导的 PCI 优化策略。该研究已完成招募，目前正在进行临床随访。预计主要结果将于 2020 年秋季公布。临床试验注册号：NCT03259815。[2020 年 4 月 3 日更正后添加：临床试验标识符添加。]
