Key result
FFR reclassifies ~50% of intermediate non-culprit lesions as non-flow limiting in multivessel STEMI.
Why the study?
It remains unclear how fractional flow reserve (FFR)-guided PCI affects hard clinical endpoints in STEMI patients with multivessel disease.
Does FFR-guided complete revascularization of non-culprit lesions reduce the combined endpoint of total mortality, non-fatal MI, and unplanned revascularization in STEMI patients with multivessel disease?
RCT (n=1,545)
randomized
Yes
Does FFR-guided complete revascularization of non-culprit lesions reduce the combined endpoint of total mortality, non-fatal MI, and unplanned revascularization in STEMI patients with multivessel disease?
Answers are grounded in this paper and cite their sources.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Previous randomized controlled trials have shown that nonculprit-lesion PCI reduces repeat revascularization. But the effect on hard endpoints like death and MI have been variable, and the benefit of FFR-guided complete revascularization on hard endpoints remains unclear.”
“whether the severity of the lesions could explain some of the differences between the FULL REVASC findings and other trials, given that only about 40% of lesions required PCI in the nonculprit vessels, whereas the number in other trials was a bit higher.”
A significant proportion of angiographically severe and intermediate non-culprit lesions in STEMI patients are non-flow limiting by FFR, highlighting the potential value of FFR guidance for complete revascularization.
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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Böhm et al. (2021) conducted an RCT in ST elevation myocardial infarction (STEMI) with multivessel disease (n=1,545). FFR-guided PCI of non-culprit lesions vs. initial conservative management of non-culprit lesions was evaluated on total mortality, non-fatal MI and unplanned revascularization. In STEMI patients with multivessel disease, FFR re-classified 20% of angiographically severe (90-99%) and 50% of intermediate (70-89%) non-culprit lesions as non-flow limiting.
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