FLOW Evaluation to Guide Revascularization in Multi-vessel ST-elevation Myocardial Infarction

Acute Myocardial Infarction Clinical Trial

— FLOWER-MI  

Official title:

FLOW Evaluation to Guide Revascularization in Multi-vessel ST-elevation Myocardial Infarction

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02943954
• Other study ID #: P150943
• Secondary ID: 2016-A00418-43AO
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2016
• Est. completion date: January 2022

Study information

• Verified date: November 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1170
• Est. completion date: January 2022
• Est. primary completion date: October 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Acute ST Segment Elevation Myocardial Infarction
• Coronary Artery Disease
• Infarction
• Multi Vessel Coronary Artery Disease
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Procedure:
• Angiography guided PCI

Device:
• Fractional Flow Reserve (FFR)

Locations

Country	Name	City	State
France	France	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Abbott, Ministry of Health, France

Country where clinical trial is conducted

France, 

References & Publications (4)

Authors/Task Force members, Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Jüni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. — View Citation

Engstrøm T, Kelbæk H, Helqvist S, Høfsten DE, Kløvgaard L, Holmvang L, Jørgensen E, Pedersen F, Saunamäki K, Clemmensen P, De Backer O, Ravkilde J, Tilsted HH, Villadsen AB, Aarøe J, Jensen SE, Raungaard B, Køber L; DANAMI-3-PRIMULTI Investigators. Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease (DANAMI-3-PRIMULTI): an open-label, randomised controlled trial. Lancet. 2015 Aug 15;386(9994):665-71. — View Citation

Ntalianis A, Sels JW, Davidavicius G, Tanaka N, Muller O, Trana C, Barbato E, Hamilos M, Mangiacapra F, Heyndrickx GR, Wijns W, Pijls NH, De Bruyne B. Fractional flow reserve for the assessment of nonculprit coronary artery stenoses in patients with acute myocardial infarction. JACC Cardiovasc Interv. 2010 Dec;3(12):1274-81. doi: 10.1016/j.jcin.2010.08.025. — View Citation

Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrøm T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611. — View Citation

Outcome

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