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Am Heart J. 2019 Dec 27;222:1-7. doi: 10.1016/j.ahj.2019.12.015. [Epub ahead of print]

Rationale and design of the Flow Evaluation to Guide Revascularization in Multivessel ST-Elevation Myocardial Infarction (FLOWER-MI) trial.

Author information

1
Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Européen Georges Pompidou, Department of Cardiology, Paris, France; Université Paris-Descartes, 75006 Paris, France; French Alliance for Cardiovascular Trials (FACT), France. Electronic address: etienne.puymirat@aphp.fr.
2
French Alliance for Cardiovascular Trials (FACT), France; AP-HP, Hôpital Saint Antoine, Department of Clinical Pharmacology and Unité de Recherche Clinique (URCEST), Paris, France; Université Pierre et Marie Curie (UPMC-Paris 06), INSERM U-698, Paris, France.
3
Cardiovascular Center Aalst, Aalst, Belgium; Department of Cardiology, Lausanne University Center Hospital, Lausanne, Switzerland.
4
Sorbonne université, ACTION Study group, Institut de Cardiologie (APHP), INSERM UMRS 1166, hôpital Pitié-Salpêtrière, Paris, France.
5
French Alliance for Cardiovascular Trials (FACT), France; Université Paris-Diderot, Sorbonne Paris Cité, INSERM Unité-1148, and Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France; Royal Brompton Hospital, Imperial College, London, United Kingdom.
6
Centre Hospitalier Universitaire de Nîmes, Nîmes, France.
7
Clinical Research Unit Eco Ile de France, Hôpital Hôtel Dieu, AP-HP, Paris, France.
8
Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Européen Georges Pompidou, Department of Cardiology, Paris, France; Université Paris-Descartes, 75006 Paris, France.
9
Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Européen Georges Pompidou, Department of Cardiology, Paris, France; Université Paris-Descartes, 75006 Paris, France; French Alliance for Cardiovascular Trials (FACT), France.
10
Clinical Research Unit and CIC 1418 INSERM, George-Pompidou European Hospital, AP-HP, Paris, France.

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.

PMID:
32000067
DOI:
10.1016/j.ahj.2019.12.015

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