Fractional flow reserve vs angiography to guide percutaneous coronary intervention: an individual patient data meta-analysis

Background and Aims 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). Methods 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). Results 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. Conclusions 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.