Mangiacapra Fabio, Paolucci Luca, De Bruyne Bernard, Rioufol Gilles, Hahn Joo-Yong, Chen Shao-Liang, Koo Bon-Kwon, Tonino Pim A L, van 't Veer Marcel, Motreff Pascal, Angoulvant Denis, Lee Joo Myung, Hwang Doyeon, Yang Seokhun, Pijls Nico H J, Barbato Emanuele
Research Unit of Cardiovascular Science, Department of Medicine and Surgery, Università Campus Bio-Medico di Roma, Rome, Italy.
Fondazione Policlinico Universitario Campus Bio-Medico, Rome, Italy.
Eur Heart J. 2025 Aug 20. doi: 10.1093/eurheartj/ehaf504.
Several randomized controlled trials (RCTs) have compared fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) with angiography-guided PCI in different clinical settings, yielding mixed results. This individual patient data meta-analysis focused on trials where FFR was used to assess intermediate coronary lesions in chronic coronary syndrome (CCS) or non-culprit vessels in non-ST-elevation acute coronary syndromes (NSTE-ACS).
Randomized controlled trials comparing FFR- vs angiography-guided PCI with a minimum follow-up of 1 year were searched. Studies lacking angiographic inclusion criteria or using FFR for culprit arteries in NSTE-ACS were excluded. Studies including patients with ST-elevation myocardial infarction (MI) or undergoing surgical revascularization could be included after censoring these two subgroups. The primary outcome was the 1-year rate of major adverse cardiac events (MACE), defined as a composite of all-cause death, MI, and repeat revascularization. The secondary outcomes were a composite of all-cause death and MI, the individual components of the primary outcome, cardiac death, spontaneous MI, and procedural MI. The present study is registered with PROSPERO (CRD42024553676).
Five RCTs were selected, including 2493 patients: 1241 in the angiography arm and 1252 in the FFR arm. More vessels underwent PCI in the angiography group (45.1% vs 30.2%, P < .001), with more stents implanted per patient [2.0 (2.0-3.0) vs 1.5 (1.0-2.0), P < .001]. One-year MACE occurred in 14.7% of patients in the angiography group and 12.1% in the FFR group [hazard ratio (HR) .80, 95% confidence interval (CI) .64-.99; P = .046]. The risk of MI was significantly reduced in the FFR-guided group (HR .71, 95% CI .53-.96; P = .031). These outcomes were driven by a reduction in peri-procedural MI with FFR guidance, with no significant difference between groups in non-procedural MI, MACE between 30 days and 1 year, and secondary outcomes.
Fractional flow reserve-guided PCI was associated with reduced major adverse events in patients with CCS and NSTE-ACS due mainly to fewer peri-procedural MIs, with no differences in mortality or MACE beyond 30 days.
多项随机对照试验(RCT)在不同临床环境中比较了血流储备分数(FFR)指导的经皮冠状动脉介入治疗(PCI)与血管造影指导的PCI,结果不一。这项个体患者数据荟萃分析聚焦于使用FFR评估慢性冠状动脉综合征(CCS)中的中度冠状动脉病变或非ST段抬高型急性冠状动脉综合征(NSTE-ACS)中非罪犯血管的试验。
检索比较FFR指导与血管造影指导的PCI且最短随访1年的随机对照试验。排除缺乏血管造影纳入标准或在NSTE-ACS中对罪犯动脉使用FFR的研究。对这两个亚组进行审查后,可纳入包括ST段抬高型心肌梗死(MI)患者或接受外科血运重建的研究。主要结局是1年主要不良心脏事件(MACE)发生率,定义为全因死亡、MI和再次血运重建的复合事件。次要结局是全因死亡和MI的复合事件、主要结局的各个组成部分、心源性死亡、自发性MI和手术相关MI。本研究已在国际前瞻性系统评价注册库(PROSPERO,注册号:CRD42024553676)登记。
选择了5项RCT,共2493例患者:血管造影组1241例,FFR组1252例。血管造影组接受PCI的血管更多(45.1%对30.2%,P <.001),每位患者植入的支架更多[2.0(2.0 - 3.0)对1.5(1.0 - 2.0),P <.001]。血管造影组14.7%的患者发生1年MACE,FFR组为12.1%[风险比(HR)0.80,95%置信区间(CI)0.64 - 0.99;P = 0.046]。FFR指导组MI风险显著降低(HR 0.71,95% CI 0.53 - 0.96;P = 0.031)。这些结局是由于FFR指导下围手术期MI减少所致,非手术相关MI、30天至1年期间的MACE及次要结局在两组间无显著差异。
FFR指导的PCI与CCS和NSTE-ACS患者主要不良事件减少相关,主要原因是围手术期MI较少,30天以后的死亡率或MACE无差异。