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Published on: June 28, 2019
Fractional Flow Reserve to Guide Treatment of Patients With Multivessel Coronary Artery Disease
Gilles Rioufol1, François Dérimay1, François Roubille2
1Hôpital Cardiologique et Pneumologique Louis Pradel, Hospices Civils de Lyon, Bron, France.
Insights
Fractional flow reserve (FFR) guidance did not reduce major adverse cardiac events in multivessel coronary artery disease (CAD). The FUTURE trial found FFR reduced revascularization rates but showed no significant difference in ischemic events or death.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- Limited evidence exists on the effectiveness of fractional flow reserve (FFR) in guiding treatment strategies for multivessel coronary artery disease (CAD).
- Previous studies have not conclusively established FFR's role beyond selecting candidates for percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).
Purpose of the Study:
- To evaluate if an FFR-guided treatment strategy is superior to a traditional strategy without FFR in managing multivessel CAD.
- To assess the impact of FFR on major adverse cardiac or cerebrovascular events (MACCE) and revascularization rates.
Main Methods:
- The FUTURE trial was a prospective, randomized, open-label superiority trial involving patients with multivessel CAD.
- Participants were randomized to an FFR-guided strategy (revascularization for lesions with FFR ≤0.80) or a traditional strategy.
- The primary endpoint was a composite of MACCE at 1-year follow-up.
Main Results:
- The trial was stopped prematurely; 927 patients were enrolled.
- No significant difference in MACCE rates was observed between the FFR-guided group (14.6%) and the control group (14.4%) at 1 year (HR: 0.97; 95% CI: 0.69-1.36).
- FFR significantly reduced revascularization rates (P=0.02), leading to more patients receiving medical management.
Conclusions:
- An FFR-guided treatment strategy did not demonstrate superiority over a traditional approach in reducing ischemic cardiovascular events or death in patients with multivessel CAD at 1-year follow-up.
- While FFR effectively reduced revascularization procedures, it did not translate to improved clinical outcomes regarding major adverse events.
Background:
There is limited evidence that fractional flow reserve (FFR) is effective in guiding therapeutic strategy in multivessel coronary artery disease (CAD) beyond prespecified percutaneous coronary intervention or coronary graft surgery candidates.
Objectives:
The FUTURE (FUnctional Testing Underlying coronary REvascularization) trial aimed to evaluate whether a treatment strategy based on FFR was superior to a traditional strategy without FFR in the treatment of multivessel CAD.
Methods:
The FUTURE trial is a prospective, randomized, open-label superiority trial. Multivessel CAD candidates were randomly assigned (1:1) to treatment strategy based on FFR in all stenotic (≥50%) coronary arteries or to a traditional strategy without FFR. In the FFR group, revascularization (percutaneous coronary intervention or surgery) was indicated for FFR ≤0.80 lesions. The primary endpoint was a composite of major adverse cardiac or cerebrovascular events at 1 year.
Results:
The trial was stopped prematurely by the data safety and monitoring board after a safety analysis and 927 patients were enrolled. At 1-year follow-up, by intention to treat, there were no significant differences in major adverse cardiac or cerebrovascular events rates between groups (14.6% in the FFR group vs 14.4% in the control group; hazard ratio: 0.97; 95% confidence interval: 0.69-1.36; P = 0.85). The difference in all-cause mortality was nonsignificant, 3.7% in the FFR group versus 1.5% in the control group (hazard ratio: 2.34; 95% confidence interval: 0.97-5.18; P = 0.06), and this was confirmed with a 24 months' extended follow-up. FFR significantly reduced the proportion of revascularized patients, with more patients referred to exclusively medical treatment (P = 0.02).
Conclusions:
In patients with multivessel CAD, we did not find evidence that an FFR-guided treatment strategy reduced the risk of ischemic cardiovascular events or death at 1-year follow-up. (Functional Testing Underlying Coronary Revascularisation; NCT01881555).
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