The Full Revasc (Ffr-gUidance for compLete non-cuLprit REVASCularization) Registry-based randomized clinical trial
Felix Böhm1, Brynjölfur Mogensen1, Ollie Östlund2
1Department of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm, Sweden.
Insights
Fractional Flow Reserve (FFR)-guided percutaneous coronary intervention (PCI) in ST-elevation myocardial infarction (STEMI) patients with multivessel disease may reduce adverse events. This trial investigates if FFR guidance improves outcomes compared to standard care.
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.
Background:
Complete revascularization in ST elevation myocardial infarction (STEMI) patients with multivessel disease has resulted in reduction in composite clinical endpoints in medium sized trials. Only one trial showed an effect on hard clinical endpoints, but the revascularization procedure was guided by angiographic evaluation of stenosis severity. Consequently, it is not clear how Fractional Flow Reserve (FFR)-guided percutaneous coronary intervention (PCI) affects hard clinical endpoints in STEMI.
Methods And Results:
The Ffr-gUidance for compLete non-cuLprit REVASCularization (FULL REVASC) - is a pragmatic, multicenter, international, registry-based randomized clinical trial designed to evaluate whether a strategy of FFR-guided complete revascularization of non-culprit lesions, reduces the combined primary endpoint of total mortality, non-fatal MI and unplanned revascularization. 1,545 patients were randomized to receive FFR-guided PCI during the index hospitalization or initial conservative management of non-culprit lesions. We found that in angiographically severe non-culprit lesions of 90-99% severity, 1 in 5 of these lesions were re-classified as non-flow limiting by FFR. Considering lesions of intermediate severity (70%-89%), half were re-classified as non-flow limiting by FFR. The study is event driven for an estimated follow-up of at least 2.75 years to detect a 9.9%/year>7.425%/year difference (HR = 0.74 at 80% power (α = .05)) for the combined primary endpoint.
Conclusion:
This large randomized clinical trial is designed and powered to evaluate the effect of complete revascularization with FFR-guided PCI during index hospitalization on total mortality, non-fatal MI and unplanned revascularization following primary PCI in STEMI patients with multivessel disease. Enrollment completed in September 2019 and follow-up is ongoing.
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