Rationale and design of the Flow Evaluation to Guide Revascularization in Multivessel ST-Elevation Myocardial Infarction (FLOWER-MI) trial - 17/03/20
, Tabassome Simon, MD, PhD c, d, e, Bernard de Bruyne, MD, PhD f, g, Gilles Montalescot, MD, PhD h, Gabriel Steg, MD c, i, j, Guillaume Cayla, MD, PhD k, Isabelle Durand-Zaleski, MD, PhD l, Didier Blanchard, MD a, b, Nicolas Danchin, MD a, b, c, Gilles Chatellier, MD mfor the
FLOWER-MI study investigators
Abstract |
Background |
In ST-elevation myocardial infarction (STEMI) patients presenting with multivessel disease (MVD), recent studies have demonstrated the superiority of fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) for non-culprit lesions compared to culprit lesion treatment-only therapy. FFR- and angio-guided PCI have however never been compared in STEMI patients.
Trial design |
FLOWER-MI is an open-label multicenter national randomized clinical trial. The aim is to investigate FFR-guided complete revascularization in comparison to angio-guided complete revascularization in STEMI patients with successful PCI of the culprit lesion and ≥50% stenosis in at least one additional non-culprit lesion requiring PCI. Eligible patients will be randomized after successful primary PCI in a 1:1 fashion to either FFR-guided or angio-guided complete revascularization during the index procedure or a staged procedure before discharge (≤5 days). Patients assigned to FFR guidance first have FFR measured in each non-culprit vessel and only undergo PCI if FFR is ≤0.80. The primary end point of the study is a composite of major adverse cardiac events, including all-cause death, non-fatal MI, and unplanned hospitalization leading to urgent revascularization at 1 year. Secondary end points will include the individual adverse events, cost-effectiveness, quality of life, and 30-day, 6-month, and 3-year outcomes. Based on estimated event rates, a sample size of 1170 patients is needed to show superiority of the FFR-guided revascularization with 80% power.
Conclusion |
The aim of FLOWER-MI trial is to assess whether FFR-guided complete revascularization in the acute setting is superior angio-guided complete revascularization.
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| ☆ | ClinicalTrials.gov Identifier: NCT02943954 |
Vol 222
P. 1-7 - avril 2020 Retour au numéro
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