Three-Year Outcomes With Fractional Flow Reserve–Guided or Angiography-Guided Multivessel Percutaneous Coronary Intervention for Myocardial Infarction
Étienne Puymirat, Guillaume Cayla, Tabassome Simon, Philippe Gabríel Steg, Gilles Montalescot, Isabelle Durand‐Zaleski, Fabiola Ngaleu Siaha, Romain Gallet, Khalifé Khalifé, Jean‐François Morelle, Pascal Motreff, Gilles Lemesle, Jean‐Guillaume Dillinger, Thibault Lhermusier, Johanne Silvain, Vincent Roule, Jean-Noël Labèque, Grégoire Rangé, Grégory Ducrocq, Yves Cottin, Didier Blanchard, Anaïs Charles Nelson, Juliette Djadi‐Prat, Gilles Châtellier, Nicolas Danchin, for the FLOWER-MI Study Investigators
Abstract
BACKGROUND: In patients with multivessel disease with successful primary percutaneous coronary intervention for ST-segment-elevation myocardial infarction, the FLOWER-MI trial (Flow Evaluation to Guide Revascularization in Multivessel ST-Elevation Myocardial Infarction) showed that a fractional flow reserve (FFR)-guided strategy was not superior to an angiography-guided strategy for treatment of noninfarct-related artery lesions regarding the 1-year risk of death from any cause, myocardial infarction, 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 ST-segment-elevation myocardial infarction and multivessel disease with successful percutaneous coronary intervention of the infarct-related artery to receive complete revascularization guided by either FFR (n=586) or angiography (n=577). RESULTS: =0.4). Death occurred in 22 patients (4.00%) in the FFR-guided group and in 23 (4.32%) in the angiography-guided group (hazard ratio, 0.96 [95% CI, 0.53-1.71]); nonfatal myocardial infarction in 23 (4.13%) and 14 (2.56%), respectively (hazard ratio, 1.63 [95% CI, 0.84-3.16]); and unplanned hospitalization leading to urgent revascularization in 21 (3.83%) and 18 (3.36%; hazard ratio, 1.15 [95% CI, 0.61-2.16]), respectively. CONCLUSIONS: Although event rates in the trial were lower than expected, in patients with ST-segment-elevation myocardial infarction undergoing complete revascularization, an FFR-guided strategy did not have a significant benefit over an angiography-guided strategy with respect to the risk of death, myocardial infarction, or urgent revascularization up to 3 years. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02943954.