NCT02943954

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 25, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

November 19, 2021

Status Verified

November 1, 2021

Enrollment Period

3.9 years

First QC Date

September 7, 2016

Last Update Submit

November 15, 2021

Conditions

Acute ST Segment Elevation Myocardial InfarctionAcute Myocardial InfarctionMulti Vessel Coronary Artery Disease

Keywords

Fractional Flow Reserve

Outcome Measures

Primary Outcomes (1)

  • Rate of major adverse cardiac events

    Number of deaths, myocardial infarctions and unplanned hospitalization leading to urgent revascularizations at one year.

    1 year

Secondary Outcomes (12)

  • Deaths

    1 year

  • Myocardial infarctions

    1 year

  • Repeat revascularizations

    1 year

  • Rate of nonculprit artery target lesion treated by urgent revascularization

    1 year

  • Rates of major adverse cardiac events at 30 days and 6 months

    30 days and 6 months

  • +7 more secondary outcomes

Study Arms (2)

Angiography guided PCI

OTHER

Revascularisation of non-culprit lesions guided by PCI

Procedure: Angiography guided PCI

FFR guided PCI

OTHER

Revascularisation of non-culprit lesions guided by FFR measurement

Device: Fractional Flow Reserve (FFR)

Interventions

Angiography guided PCIPROCEDURE
Angiography guided PCI
Fractional Flow Reserve (FFR)DEVICE
FFR guided PCI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

France

Paris, 75015, France

Location

Related Publications (8)

  • Authors/Task Force members; Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni 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. No abstract available.

    PMID: 25173339BACKGROUND

  • Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrom 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.

    PMID: 19144937BACKGROUND

  • 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.

    PMID: 21232721BACKGROUND

  • Engstrom T, Kelbaek H, Helqvist S, Hofsten DE, Klovgaard L, Holmvang L, Jorgensen E, Pedersen F, Saunamaki K, Clemmensen P, De Backer O, Ravkilde J, Tilsted HH, Villadsen AB, Aaroe J, Jensen SE, Raungaard B, Kober 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. doi: 10.1016/s0140-6736(15)60648-1.

    PMID: 26347918BACKGROUND

  • Puymirat E, Cayla G, Simon T, Steg PG, Montalescot G, Durand-Zaleski I, Ngaleu Siaha F, Gallet R, Khalife K, Morelle JF, Motreff P, Lemesle G, Dillinger JG, Lhermusier T, Silvain J, Roule V, Labeque JN, Range G, Ducrocq G, Cottin Y, Blanchard D, Charles Nelson A, Djadi-Prat J, Chatellier G, Danchin N; FLOWER-MI Study Investigators. Three-Year Outcomes With Fractional Flow Reserve-Guided or Angiography-Guided Multivessel Percutaneous Coronary Intervention for Myocardial Infarction. Circ Cardiovasc Interv. 2024 Jun;17(6):e013913. doi: 10.1161/CIRCINTERVENTIONS.123.013913. Epub 2024 May 24.

    PMID: 38785084DERIVED

  • Denormandie P, Simon T, Cayla G, Steg PG, Montalescot G, Durand-Zaleski I, le Bras A, le Breton H, Valy Y, Schiele F, Cuisset T, Vanzetto G, Levesque S, Goube P, Nallet O, Angoulvant D, Roubille F, Charles Nelson A, Chatellier G, Danchin N, Puymirat E. Compared Outcomes of ST-Segment-Elevation Myocardial Infarction Patients With Multivessel Disease Treated With Primary Percutaneous Coronary Intervention and Preserved Fractional Flow Reserve of Nonculprit Lesions Treated Conservatively and of Those With Low Fractional Flow Reserve Managed Invasively: Insights From the FLOWER-MI Trial. Circ Cardiovasc Interv. 2021 Nov;14(11):e011314. doi: 10.1161/CIRCINTERVENTIONS.121.011314. Epub 2021 Aug 23.

    PMID: 34420366DERIVED

  • Puymirat E, Cayla G, Simon T, Steg PG, Montalescot G, Durand-Zaleski I, le Bras A, Gallet R, Khalife K, Morelle JF, Motreff P, Lemesle G, Dillinger JG, Lhermusier T, Silvain J, Roule V, Labeque JN, Range G, Ducrocq G, Cottin Y, Blanchard D, Charles Nelson A, De Bruyne B, Chatellier G, Danchin N; FLOWER-MI Study Investigators. Multivessel PCI Guided by FFR or Angiography for Myocardial Infarction. N Engl J Med. 2021 Jul 22;385(4):297-308. doi: 10.1056/NEJMoa2104650. Epub 2021 May 16.

    PMID: 33999545DERIVED

  • Puymirat E, Simon T, de Bruyne B, Montalescot G, Steg G, Cayla G, Durand-Zaleski I, Blanchard D, Danchin N, Chatellier G; FLOWER-MI study investigators. Rationale and design of the Flow Evaluation to Guide Revascularization in Multivessel ST-Elevation Myocardial Infarction (FLOWER-MI) trial. Am Heart J. 2020 Apr;222:1-7. doi: 10.1016/j.ahj.2019.12.015. Epub 2019 Dec 27.

    PMID: 32000067DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Etienne PUYMIRAT, MD

    AP - HP, Hôpital Europeen Georges-Pompidou, Paris, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2016

First Posted

October 25, 2016

Study Start

December 1, 2016

Primary Completion

October 24, 2020

Study Completion

January 1, 2022

Last Updated

November 19, 2021

Record last verified: 2021-11

Locations

FR(1)