Abstract Background and Aims The optimal approach to coronary revascularization in patients undergoing transcatheter aortic valve implantation (TAVI) remains debated. Fractional flow reserve (FFR) may improve the identification of ischaemia-producing lesions compared to angiographic assessment alone, but data in the TAVI population are lacking. Methods In this multicentric, open-label, randomized, superiority trial with blind adjudication of adverse events, patients with aortic stenosis and intermediate coronary lesions undergoing TAVI were randomized 1:1 to FFR-guided or angiography-guided percutaneous coronary intervention (PCI). The trial was registered at ClinicalTrials.gov (NCT03360591). All randomized patients were included in the primary analysis according to the intention-to-treat principle. The primary endpoint was a major adverse cardiac and cerebrovascular event (MACCE) at 12 months of follow-up, defined as a composite of all-cause death, myocardial infarction, ischaemia-driven target vessel revascularization, disabling stroke, or major bleeding. Results A total of 320 patients were enrolled across 15 Italian centres. The median age of the patients was 86 years interquartile range (IQR) 83–90, and the median STS score was 3% (IQR 2–5). The median SYNTAX score was 7 (IQR 5–11). FFR-guided PCI was associated with a significantly lower rate of MACCE at 12 months compared with angiography-guided PCI (8.5% vs 16.0%; hazard ratio .52; 95% confidence interval .27–.99; P = .047). The difference in the primary endpoint was primarily driven by a reduction in all-cause mortality (hazard ratio .31; 95% confidence interval .10–.96). Other components of the composite were numerically lower but not statistically significant. Conclusions In patients undergoing TAVI with intermediate coronary lesions, FFR-guided PCI was associated with a reduced risk of MACCE at 12 months. These findings support a physiology-based revascularization strategy in this frail, elderly population.
Ribichini et al. (Wed,) studied this question.