Three-year outcomes with fractional flow reserve- or angiography-guided multivessel percutaneous coronary intervention for myocardial infarction

Background: In multivessel disease (MVD) patients with successful primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI), the Flow Evaluation to Guide Revascularization in Multivessel ST-Elevation Myocardial Infarction (FLOWER-MI) trial showed that a fractional flow reserve (FFR)-guided strategy was not superior to an angiography-guided strategy for treatment of non-infarct-related artery lesions regarding the one-year risk of death from any cause, MI, or unplanned hospitalization leading to urgent revascularization. The extension phase of the trial was planned using the same primary outcome to determine whether a difference in outcomes would be observed with a longer follow-up. Methods: In this multicenter trial, we randomly assigned patients with STEMI and MVD with successful PCI of the infarct-related artery to receive complete revascularization guided by either FFR (n=586) or angiography (n=577). Results: After 3 years, a primary outcome event occurred in 52 of 498 patients in the FFR-guided group and in 44 of 502 patients in the angiography-guided group (hazard ratio[HR], 1.19; 95% confidence interval [CI], 0.79-1.77; P=0.4). Death occurred in 22 patients in the FFR-guided group and in 23 in the angiography-guided group (HR, 0.96; 95% CI 0.53-1.71); nonfatal MI in 23 and 14), respectively (HR, 1.63; 95% CI 0.84-3.16); and unplanned hospitalization leading to urgent revascularization in 21 and 18 (HR, 1.15; 95% CI 0.61-2.16), respectively. Conclusions: Although event rates in the trial were lower than expected, in patients with STEMI undergoing complete revascularization, an FFR-guided strategy had not a significant benefit over an angiography-guided strategy with respect to the risk of death, MI, or urgent revascularization up to 3 years. (Funded by the French Ministry of Health and Abbott; FLOWER-MI ClinicalTrials.gov number, NCT02943954.)