FLOW Evaluation to Guide Revascularization in Multi-vessel ST-elevation Myocardial Infarction (FLOWER-MI)

November 15, 2021 updated by: Assistance Publique - Hôpitaux de Paris

Although current guidelines recommend fractional flow reserve (FFR) to identify haemodynamically relevant coronary lesion(s) in stable patients when evidence of ischaemia is not available (Class I, Level of Evidence: A), no published study has assessed the usefulness of FFR to guide percutaneous coronary intervention (PCI) in ST-elevation myocardial infarction (STEMI) patients with multi-vessel disease (MVD).

The main objective of this study is to determine whether, in STEMI patients with MVD amenable to PCI, the use of FFR in addition to angiography will improve cardiovascular outcomes, compared with the current practice of angiography- guided PCI, by improving the appropriateness of revascularisations by assessing the relevance of non-culprit lesions in the context of STEMI with multivessel coronary artery disease.

The secondary objective is to assess the safety and the cost-effectiveness of the FFR-guided strategy compared to the angiography-guided strategy.

Study Overview

Detailed Description

The optimal revascularisation strategy in STEMI patients with MVD is currently debated. Recent data suggest that MV-PCI may be the most appropriate option for treating such patients. Consequently, the real challenge becomes to define what MVD is, in the context of acute MI, in order to limit revascularisation by PCI to vessels that truly need it. Visual estimation of the degree of coronary stenoses is a poor indicator of their haemodynamic severity. FFR is precisely designed and recommended in current guidelines to provide objective guidance for the functional assessment of lesion severity during coronary angiography in stable patients, but it has not been validated in STEMI patients with MVD. The purpose of the present trial will therefore be to investigate the relevance of FFR to guide the revascularisation management of patients at the acute stage of STEMI.

STEMI patients with successful culprit lesion PCI (primary, rescue or pharmaco-invasive) and ≥ 50% diameter stenosis by visual estimate, in which revascularization is contemplated and judged amenable to PCI in at least one additional non-culprit lesion will be randomized into two groups: angiography-guided PCI or FFR-guided PCI.

If the patient is randomized to the angiography-guided PCI, all the lesions indicated beforehand will be treated. If the patient is randomized to the FFR-guided PCI, measurements of FFR of non-infarct related lesion(s) will be performed and only those lesions with a FFR ≤ 0.80 will be treated.

The use of drug-eluting stents is encouraged in both strategies. All patients will receive optimal medical therapy (including dual antiplatelet therapy, beta-blockers, statins, ACE-I or ARB) as recommended in international guidelines in both strategies.

Clinical follow-up will be performed at discharge, 30-day, 6 month and one-year. Rates of major adverse cardiac events, functional class and number of anti-anginal medications used will be collected. If the patient has been rehospitalized since index hospital discharge, the discharge summary and all relevant information will be collected.

Study Type

Interventional

Enrollment (Anticipated)

1170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Paris, France, 75015
        • France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • STEMI patients ≥ 18 years old with successful culprit lesion PCI (primary, rescue or pharmaco-invasive) and ≥ 50% stenosis judged amenable to PCI in at least one additional non-culprit lesion
  • Written informed consent

Exclusion Criteria:

  • Patients with cardiogenic shock (SBP < 90 mmHg with clinical signs of low output or patients requiring inotropic agents)
  • Patients with MVD referred to surgery for CABG or treatment of acute complications (e.g. ventricular septal rupture)
  • Patients with one-vessel disease
  • Previous coronary bypass surgery
  • Extremely tortuous, calcified coronary vessels or chronic total occlusion (CTO)
  • Life expectancy < 2 years
  • Patients with known hypersensitivity to adenosine
  • Pregnancy
  • Participation in another interventional therapeutic study at the same time or within 3 months prior to the beginning of the present study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Angiography guided PCI
Revascularisation of non-culprit lesions guided by PCI
Other: FFR guided PCI
Revascularisation of non-culprit lesions guided by FFR measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of major adverse cardiac events
Time Frame: 1 year
Number of deaths, myocardial infarctions and unplanned hospitalization leading to urgent revascularizations at one year.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deaths
Time Frame: 1 year
1 year
Myocardial infarctions
Time Frame: 1 year
1 year
Repeat revascularizations
Time Frame: 1 year
1 year
Rate of nonculprit artery target lesion treated by urgent revascularization
Time Frame: 1 year
1 year
Rates of major adverse cardiac events at 30 days and 6 months
Time Frame: 30 days and 6 months
30 days and 6 months
Rehospitalization for angina during the follow up period
Time Frame: 1 year
1 year
Procedure time
Time Frame: 5 days
5 days
Functional class at 1 year
Time Frame: 1 year
The functional class is assessed with the use of the Canadian Cardiovascular Society classification of angina.
1 year
Health-related quality of life
Time Frame: 1 year
Health-related quality of life is assessed by the European Quality of Life-5 Dimensions [EQ-5D] questionnaires
1 year
Anti-anginal medications used
Time Frame: 1 month, 6 months and 1 year
Number of anti-anginal medications used
1 month, 6 months and 1 year
Cost effectiveness
Time Frame: 1 year
Incremental cost effectiveness ratio (ICER) using the composite endpoint (all-cause death, myocardial infarctions and repeat revascularizations).
1 year
Cost utility
Time Frame: 1 year
Incremental cost-utility ration (ICUR) using quality-adjusted life years (QALYs)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Etienne PUYMIRAT, MD, AP - HP, Hôpital Européen Georges-Pompidou, Paris, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

October 24, 2020

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

September 7, 2016

First Submitted That Met QC Criteria

October 24, 2016

First Posted (Estimate)

October 25, 2016

Study Record Updates

Last Update Posted (Actual)

November 19, 2021

Last Update Submitted That Met QC Criteria

November 15, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • P150943
  • 2016-A00418-43 (Other Identifier: Agence Nationale de Securite du Medicament et des Produits de Sante)
  • AOM15608 (Other Grant/Funding Number: French Ministry of Health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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