Functional Assessment in Elderly MI Patients With Multivessel Disease

NCT03772743 | Active Not Recruiting DMC

• 1 other identifier: 56/2019/Sper/AOUFe
• Study Type: interventional
• Target: 1,445
• Locations: 3 countries
• Sites: 37

Brief Summary

Elderly patients presenting with myocardial infarction (MI) and multivessel disease are the highest risk population with the worst prognosis. No trial has ever been designed to optimize their outcome. The actual real-life standard of care is, in the best of the cases, culprit only revascularization. However, real-life registries show that outcome of MI elderly patients treated with this strategy is far from being optimal with at least a 15% rate of cardiac death or myocardial infarction at 1 year. To date, studies on this population have been focused on devices (bare metal stent vs biodegradable drug eluting stent) or on dual antiplatelet regimen (long vs short) and no study was focused on evaluating if complete revascularization is able to improve the prognosis in these patients. The contemporary complete revascularization is represented by a functionally-driven revascularization that recently showed to significantly reduce myocardial infarction rate and outperformed an angio-complete revascularization. Thus, our hypothesis is that a functionally-driven complete revascularization in elderly patients with MI and multivessel disease may improve prognosis compared to the actual standard of care in these patients, namely culprit only revascularization. Being a "strategy" trial, we identified the patient-oriented composite endpoint (POCE) as primary outcome of interest (all cause death, any MI, any stroke, any revascularization). Several pre-specified substudies have been planned. A detailed list of the substudies is available in the website of the trial (http://www.thefiretrial.com)

Conditions

Myocardial Infarction

Keywords

older adults; multivessel coronary disease; intracoronary physiology; functional assessment

Outcome Measures

Primary Outcomes (1)

• Patient oriented cardiac events

  cumulative occurrence of all-cause death, any MI, any stroke, any revascularization

  1-year

Secondary Outcomes (23)

• Patient oriented cardiac events

  3-year

• Patient oriented cardiac events

  5-year

• Device oriented composite endpoint

  1-year

• Device oriented composite endpoint

  3-year

• Device oriented composite endpoint

  5-year

Other Outcomes (15)

• Target Lesion Failure

  1-year

• Target Lesion Failure

  3-year

• Target Lesion Failure

  5-year

Study Arms (2)

Culprit-only revascularization

OTHER

All patients randomized to culprit only revascularization must not undergo percutaneous coronary intervention (PCI) any lesion except from the culprit lesion already treated at the moment of the randomization. Staged procedures are considered protocol violation.

Other: Culprit-only revascularization

Complete functionally-guided revascularization

OTHER

Patients who are randomized to this strategy will receive revascularization of the culprit lesion and guided by functional assessment on all non-culprit lesions. Functional evaluation is mandatory for all stenosis with diameter stenosis % between 50 and 90% at visual estimation. Revascularization must be guided by functional assessment on all vessels. The system utilized to obtain functional evaluation is left to Operator's discretion. PCI is allowed only if functional evaluation is positive according to the threshold of the chosen functional system. It is suggested to achieve functional complete revascularization within the index procedure, while it is mandatory to obtain it within the index hospitalization.

Other: Complete functionally-guided revascularization

Interventions

Culprit-only revascularization OTHER

Implantation of drug eluting stents with biodegradable polymer with struts ≤65 μ in the culprit lesion of the MI. Each patient should receive revascularization with Supraflex stent or its newer versions

Culprit-only revascularization

Complete functionally-guided revascularization OTHER

Implantation of drug eluting stents with biodegradable polymer with struts ≤65 μ in the culprit lesion of the MI and in all non culprit lesions with positive functional assessment. Each patient should receive revascularization with Supraflex stent or its newer versions

Complete functionally-guided revascularization

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients ≥75 years AND
• MI (ST-segment elevation or not ST.segment elevation MI) with indication to invasive management AND
• Multi-vessel disease defined as at least 1 non-culprit coronary artery lesion at least 2.5 mm in diameter deemed at visual estimation with a diameter stenosis % ranging from 50 to 99% amenable to successful treatment with PCI AND
• Successful treatment of culprit lesion

You may not qualify if:

• Planned surgical revascularization
• Non-cardiovascular co-morbidity reducing life expectancy to \< 1 year
• Any factor precluding 1-year follow-up
• Prior Coronary Artery Bypass Graft (CABG) Surgery
• Impossibility to identify a clear culprit lesion
• Non culprit lesion located in the left main

Sponsors & Collaborators

• Consorzio Futuro in Ricerca: lead

Study Sites (37)

Ospedale Maggiore

Bologna, Bologna, Italy

Location

AOU Ferrara

Ferrara, Ferrara, 44124, Italy

Location

Maria Cecilia Hospital

Cotignola, Ravenna, Italy

Location

Ospedale Santa Maria delle Croci

Ravenna, Ravenna, Italy

Location

Arcispedale Santa Maria Nuova

Reggio Emilia, Reggio Emilia, Italy

Location

Ospedale Infermi

Rimini, Rimini, Italy

Location

ASP Agrigento

Agrigento, Italy

Location

AOU Sant'Anna e San Sebastiano

Caserta, Italy

Location

Casa di Cura San Michele Maddaloni

Caserta, Italy

Location

AO Cannizzaro

Catania, Italy

Location

Ospedale della Misericordia

Grosseto, Italy

Location

Ospedale Sant.Andrea

La Spezia, Italy

Location

AOU Gaetano Martino

Messina, Italy

Location

Ospedale dell'Angelo

Mestre, Italy

Location

Ospedale Civile di Baggiovara

Modena, Italy

Location

Ospedale Santa Croce

Moncalieri, Italy

Location

AOU Giaccone

Palermo, Italy

Location

AOU Sant'Andrea

Roma, Italy

Location

Ospedale SS Annunziata

Savigliano, Italy

Location

Ospedale Umberto I

Syracuse, Italy

Location

Ospedale di Rivoli

Torino, Italy

Location

AOU Integrata di Verona

Verona, Italy

Location

Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii

Krosno, Poland

Location

Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii

Nowy Sącz, Poland

Location

Centrum Kardiologii Inwazyjnej Elektroterapii i Angiologii

Oświęcim, Poland

Location

Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii

Pińczów, Poland

Location

Podkarpackie Centrum Interwencji Sercowo-Naczyniowych

Sanok, Poland

Location

Complejo Hospitalario de La Coruna

A Coruña, Spain

Location

Hospital General Universitario de Ciudad Real

Ciudad Real, Spain

Location

Hospital Universitario Lucus Augusti

Lugo, Spain

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, Spain

Location

Hospital Universitario La FE

Valencia, Spain

Location

Hospital Clinico Universitario

Valladolid, Spain

Location

Hospital Alvaro Conqueiro de Vigo

Vigo, Spain

Location

Related Publications (9)

• Biscaglia S, Guiducci V, Santarelli A, Amat Santos I, Fernandez-Aviles F, Lanzilotti V, Varbella F, Fileti L, Moreno R, Giannini F, Colaiori I, Menozzi M, Redondo A, Ruozzi M, Gutierrez Ibanes E, Diez Gil JL, Maietti E, Biondi Zoccai G, Escaned J, Tebaldi M, Barbato E, Dudek D, Colombo A, Campo G. Physiology-guided revascularization versus optimal medical therapy of nonculprit lesions in elderly patients with myocardial infarction: Rationale and design of the FIRE trial. Am Heart J. 2020 Nov;229:100-109. doi: 10.1016/j.ahj.2020.08.007. Epub 2020 Aug 18.

  PMID: 32822656 BACKGROUND

• Sarti A, Erriquez A, Dal Passo B, Casella G, Guiducci V, Moreno R, Escaned J, Marchini F, Cocco M, Verardi FM, Clo S, Caglioni S, Farina J, Barbato E, Vadala G, Cavazza C, Capecchi A, Gallo F, Campo G, Biscaglia S. Complete Revascularization in Older Patients With Myocardial Infarction With or Without Complex Nonculprit Lesions. Circ Cardiovasc Interv. 2025 Nov;18(11):e015902. doi: 10.1161/CIRCINTERVENTIONS.125.015902. Epub 2025 Oct 3.

  PMID: 41039960 DERIVED

• Biscaglia S, Erriquez A, Guiducci V, Escaned J, Moreno R, Lanzilotti V, Santarelli A, Cerrato E, Sacchetta G, Menozzi A, Amat-Santos I, Diez Gil JL, Ruozzi M, Barbierato M, Fileti L, Picchi A, Pavasini R, Cimaglia P, Colaiori I, Casella G, Menozzi M, Cavazza C, Caretta G, Scarsini R, D'Amico G, Vadala G, Pilato G, Moscarella E, Tebaldi M, Campo G. Physiology-Guided Complete Revascularization in Older Patients With Myocardial Infarction: Three-Year Outcomes of a Randomized Clinical Trial. JAMA Cardiol. 2025 Nov 1;10(11):1130-1137. doi: 10.1001/jamacardio.2025.3099.

  PMID: 40879426 DERIVED

• Cocco M, Campo G, Guiducci V, Casella G, Cavazza C, Cerrato E, Sacchetta G, Moreno R, Menozzi A, Amat Santos I, Diez Gil JL, Scarsini R, Picchi A, Vadala G, Pilato G, Colaiori I, Barbierato M, Arioti M, Pavasini R, Lanzilotti V, Menozzi M, Varbella F, Erriquez A, Biscaglia S. Complete vs Culprit-Only Revascularization in Older Patients With Myocardial Infarction With or Without ST-Segment Elevation. J Am Coll Cardiol. 2024 Nov 12;84(20):2014-2022. doi: 10.1016/j.jacc.2024.07.028. Epub 2024 Aug 31.

  PMID: 39217557 DERIVED

• Campo G, Guiducci V, Escaned J, Moreno R, Casella G, Cavazza C, Cerrato E, Contarini M, Arena M, Iniguez Romo A, Gutierrez Ibanes E, Scarsini R, Vadala G, Ando G, Pilato G, Musto d'Amore S, Capecchi A, Trillo Nouche R, Moscarella E, Gambino A, Pavani M, Zanetti A, Pesenti N, Dudek D, Barbato E, Tebaldi M, Biscaglia S. Health-Status Outcomes in Older Patients With Myocardial Infarction: Physiology-Guided Complete Revascularization Versus Culprit-Only Strategy. Circ Cardiovasc Qual Outcomes. 2024 Jul;17(7):e010490. doi: 10.1161/CIRCOUTCOMES.123.010490. Epub 2024 Jun 18.

  PMID: 38887951 DERIVED

• Erriquez A, Campo G, Guiducci V, Casella G, Menozzi M, Cerrato E, Sacchetta G, Moreno R, Arena M, Amat Santos I, Diez Gil JL, Scarsini R, Ruozzi M, Arioti M, Picchi A, Barbierato M, Moscarella E, Musto D'Amore S, Lanzilotti V, Cavazza C, Rezzaghi M, Cocco M, Marrone A, Verardi FM, Escaned J, Barbato E, Colaiori I, Pesenti N, Carrara G, Biscaglia S. QFR for the Revascularization of Nonculprit Vessels in MI Patients: Insights From the FIRE Trial. JACC Cardiovasc Interv. 2024 Jun 24;17(12):1425-1436. doi: 10.1016/j.jcin.2024.04.022. Epub 2024 May 14.

  PMID: 38752972 DERIVED

• Erriquez A, Campo G, Guiducci V, Escaned J, Moreno R, Casella G, Menozzi M, Cerrato E, Sacchetta G, Menozzi A, Santos IA, Ibanes EG, Scarsini R, Vadala G, Ando G, Diez-Gil JL, d'Amore SM, Capecchi A, Colaiori I, Gallo F, Pavasini R, Marrone A, Pompei G, Lanzilotti V, Dudek D, Barbato E, Tebaldi M, Biscaglia S. Complete vs Culprit-Only Revascularization in Older Patients With Myocardial Infarction and High Bleeding Risk: A Randomized Clinical Trial. JAMA Cardiol. 2024 Jun 1;9(6):565-573. doi: 10.1001/jamacardio.2024.0804.

  PMID: 38717753 DERIVED

• Pavasini R, Campo G, Serenelli M, Tonet E, Guiducci V, Escaned J, Moreno R, Casella G, Cavazza C, Varbella F, Sacchetta G, Arena M, Santos IA, Ibanes EG, Scarsini R, D'Amico G, Ruiz-Poveda FL, Diez Gil JL, Pignatelli G, Iannopollo G, Colaiori I, Santos RC, Marrone A, Fileti L, Rigattieri S, Barbato E, Ocaranza-Sanchez R, Biscaglia S. Impact of pre-admission physical activity on benefits of physiology-guided complete revascularization in older patients with myocardial infarction: insights from the FIRE trial. Eur J Prev Cardiol. 2024 Sep 6;31(12):1451-1459. doi: 10.1093/eurjpc/zwae069.

  PMID: 38452238 DERIVED

• Biscaglia S, Guiducci V, Escaned J, Moreno R, Lanzilotti V, Santarelli A, Cerrato E, Sacchetta G, Jurado-Roman A, Menozzi A, Amat Santos I, Diez Gil JL, Ruozzi M, Barbierato M, Fileti L, Picchi A, Lodolini V, Biondi-Zoccai G, Maietti E, Pavasini R, Cimaglia P, Tumscitz C, Erriquez A, Penzo C, Colaiori I, Pignatelli G, Casella G, Iannopollo G, Menozzi M, Varbella F, Caretta G, Dudek D, Barbato E, Tebaldi M, Campo G; FIRE Trial Investigators. Complete or Culprit-Only PCI in Older Patients with Myocardial Infarction. N Engl J Med. 2023 Sep 7;389(10):889-898. doi: 10.1056/NEJMoa2300468. Epub 2023 Aug 26.

  PMID: 37634150 DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

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

Model Details: All comers, prospective, randomized, multicenter, open-label trial with blinded adjudicated evaluation of outcomes (PROBE).

Study Record Dates

• First Submitted: December 9, 2018
• First Posted: December 11, 2018
• Study Start: July 15, 2019
• Primary Completion: October 30, 2022
• Study Completion (Estimated): October 3, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After the publication of the manuscripts reporting the primary outcome and the prespecified substudies
• Access Criteria: Data will be available after motivated request to the Executive Committee of the study. All requests will be evaluated for acceptance. Positive evaluation by the Executive Committee is mandatory before data release

Locations

PL (5); ES (10); IT (22)