The Full Revasc (Ffr-gUidance for compLete non-cuLprit REVASCularization) Registry-based randomized clinical trial

Area of Science:

• Cardiology
• Interventional Cardiology
• Clinical Trials

Background:

• Complete revascularization in ST-elevation myocardial infarction (STEMI) with multivessel disease has shown promise in reducing composite endpoints.
• Previous trials often relied on angiographic severity, not functional assessment, leaving the role of Fractional Flow Reserve (FFR)-guided intervention unclear for hard clinical endpoints.

Purpose of the Study:

• To evaluate if FFR-guided complete revascularization of non-culprit lesions in STEMI patients reduces the combined primary endpoint of total mortality, non-fatal myocardial infarction (MI), and unplanned revascularization.
• To assess the impact of FFR guidance on hard clinical outcomes in STEMI patients with multivessel disease.

Main Methods:

• The FULL REVASC trial is a pragmatic, multicenter, international, registry-based randomized clinical trial.
• 1,545 patients were randomized to either FFR-guided PCI of non-culprit lesions during index hospitalization or conservative management.
• Follow-up is event-driven for at least 2.75 years to detect a significant difference in the primary endpoint.

Main Results:

• FFR reclassified many angiographically severe lesions: 1 in 5 lesions with 90-99% stenosis and half of lesions with 70-89% stenosis were found to be non-flow limiting.
• This highlights the potential for FFR to guide more accurate revascularization decisions.

Conclusions:

• This large randomized trial is powered to determine if FFR-guided complete revascularization during index hospitalization improves outcomes in STEMI patients with multivessel disease.
• Enrollment is complete, and ongoing follow-up will provide crucial data on mortality, MI, and revascularization rates.