For the roughly one-third of patients undergoing transcatheter aortic valve replacement who also carry significant coronary artery disease, the question of how aggressively to treat those lesions has long been unresolved. This trial offers the first randomized evidence that the answer matters enormously — and that the tool used to make the decision is equally consequential.
The FAITAVI trial enrolled 320 patients with aortic stenosis and intermediate coronary lesions across 15 Italian centers, randomizing them 1:1 to either fractional flow reserve (FFR)-guided or standard angiography-guided percutaneous coronary intervention (PCI) performed alongside TAVI. The median patient age was 86 years — a genuinely elderly, high-risk cohort with a median STS surgical risk score of 3%. At 12-month follow-up, the FFR-guided group experienced a composite major adverse cardiac and cerebrovascular event (MACCE) rate of just 8.5%, compared to 16.0% in the angiography-guided group — a hazard ratio of 0.52 (95% CI 0.27–0.99; P = .04), representing roughly a halving of risk. The composite endpoint encompassed all-cause death, myocardial infarction, ischemia-driven revascularization, disabling stroke, and major bleeding.
This finding matters because FFR has already transformed decision-making in stable coronary disease in general populations — the landmark FAME trials established that treating only hemodynamically significant lesions (FFR ≤ 0.80) reduces unnecessary interventions and improves outcomes. Yet the TAVI population presents unique physiological challenges: severe aortic stenosis distorts coronary pressure gradients, raising legitimate concerns about whether FFR accurately reflects true ischemia burden in this setting. FAITAVI directly confronts that uncertainty with a properly randomized design and intent-to-treat analysis, which strengthens its credibility considerably. Key limitations include its open-label design, enrollment exclusively at Italian centers, a relatively modest sample size limiting subgroup precision, and a low baseline SYNTAX score suggesting patients had anatomically mild disease overall. Whether findings generalize to more complex coronary anatomy remains open. Still, for an 86-year-old undergoing valve replacement, avoiding unnecessary stenting and its attendant bleeding risk appears clinically meaningful — this trial may be practice-changing for TAVI heart teams.