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.