Functional Versus Culprit-only Revascularization in Elderly Patients With Myocardial Infarction and Multivessel Disease

Official 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)

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 1,445 participants

Interventions

• OTHER: Culprit-only revascularization — 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
• OTHER: Complete functionally-guided revascularization — 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

Primary Outcomes

• Patient oriented cardiac events (1-year)

Secondary Outcomes

• 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)

Trial Locations

• Ospedale Maggiore, Bologna, Bologna, Italy
• AOU Ferrara, Ferrara, Ferrara, Italy
• Maria Cecilia Hospital, Cotignola, Ravenna, Italy
• Ospedale Santa Maria delle Croci, Ravenna, Ravenna, Italy
• Arcispedale Santa Maria Nuova, Reggio Emilia, Reggio Emilia, Italy
• Ospedale Infermi, Rimini, Rimini, Italy
• ASP Agrigento, Agrigento, Italy
• AOU Sant'Anna e San Sebastiano, Caserta, Italy
• Casa di Cura San Michele Maddaloni, Caserta, Italy
• AO Cannizzaro, Catania, Italy
• ...and 10 more locations

More Myocardial Infarction Trials

View all Myocardial Infarction clinical trials