No FLAVOUR difference between FFR and IVUS for PCI guidance

Among patients with intermediate coronary stenosis, using fractional flow reserve (FFR) to guide percutaneous coronary intervention (PCI) and optimise stent implantation was non-inferior to using intravascular ultrasound (IVUS) guidance.

The FLAVOUR trial (NCT02673424), presented by Prof. Bon-Kwon Koo (Seoul National University College of Medicine, Korea), was designed to test the non-inferiority of FFR-guided PCI versus IVUS-guided PCI in patients with intermediate coronary stenosis [1]. PCI was indicated in the FFR arm if FFR was ≤0.8 and considered optimised if post-PCI FFR was ≥0.88; for the IVUS arm, PCI was indicated if the minimal luminal area (MLA) was ≤3 mm², or >3 to 4 mm² with a plaque burden of >70% and considered optimised if post-PCI MLA ≥5.5 mm² and plaque burden at stent edge ≤55%. The primary endpoint was a composite of all-cause death, myocardial infarction, or repeat revascularisation.

PCI was performed significantly less frequently in the FFR arm than in the IVUS arm (44.4% vs 65.3%, P<0.001). The number of stents implanted per patient was also significantly lower in the FFR group than in the IVUS arm (0.6 ± 0.9 vs 0.9 ± 1.0; P<0.001). In addition, fewer patients received dual antiplatelet therapy in the FFR arm than in the IVUS arm (58.1% vs 71.8%).

At 24 months, no difference was seen between the IVUS (n=836) and FFR (n=832) arms with regard to the primary endpoint of all-cause death, myocardial infarction, or any repeat revascularisation procedure (8.1% vs 8.5%, P_{non-inferiority}=0.015). Neither was any significant difference observed between the arms when the patients were stratified by treatment: the PCI cohort (FFR n=466 and IVUS n=293; 11.9% vs 9.9%; P=0.313) fared equally well as patients treated by medical therapy (FFR n=372 and IVUS n=551; 5.0% vs 5.9%; P=0.622).

Analyses of each individual component of the primary endpoint provided similar results and did not indicate any differences between the FFR and IVUS groups. All-cause death (1.3% vs 2.3%; P=0.147), myocardial infarction (1.9% vs 1.7%; P=0.696), and repeat revascularisation (5.7% vs 5.3%; P=0.713) were the same between the 2 arms. Accordingly, patient-reported outcomes, as assessed by the Seattle Angina Questionnaire given at follow-up, were also the same between the FFR and IVUS groups.

In conclusion, the FLAVOUR trial provided evidence that either FFR or IVUS can be used to guide PCI and optimise stent implantation.

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   1. Koo BK, et al. Comparison Of Fractional Flow Reserve-guided And Intravascular Ultrasound-guided Percutaneous Coronary Intervention In Intermediate Coronary Artery Stenosis: The FLAVOUR Randomized Clinical Trial. Abstract 410–10, ACC 2022, 2–4 April, Washington DC, USA.

 

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Posted on 15 June, 2022