Coronary artery disease is present in 50 to 70% of TAVI candidates and over 90% of these patients do not present angina or evidence of ischemia.
The aim of the FAITAVI study was to assess whether percutaneous coronary intervention (PCI) of lesions deemed physiologically significant in TAVI candidates could be beneficial or harmful.
This was a prospective, multicenter, randomized, open-label, superiority trial, including 320 patients randomized 1:1. The decision to perform PCI (either before or after TAVI) was based on the presence of ≥50% stenosis by angiography or ≤0.80 FFR by physiological assessment.
Mean patient age was 86. The primary outcome was a composite of all-cause mortality, myocardial infarction (MI), ischemia-driven revascularization, stroke, or major bleeding at 12 months.
FFR-guided PCI reduced the primary composite outcome by 48% (HR 0.52; 95% CI 0.27–0.99; P=0.047). When evaluating the primary outcome individual components, there were reductions in all-cause mortality (HR 0.31; 95% CI 0.10–0.96) and stroke incidence (HR 0.24; 95% CI 0.03–2.11).
The authors concluded that the FFR-guided strategy significantly reduced adverse events at 12 months. FAITAVI provides supporting evidence for the use of physiological assessment in the elderly and frail population usually considered for TAVI.
Presented by Flavio Ribichini during the Major Late Breaking Trials session, EuroPCR 2025, May 21, Paris, France.
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