Deferral of percutaneous coronary intervention in patients undergoing transcatheter aortic valve implantation (PRO-TAVI): an investigator-initiated, multicentre, open-label, non-inferiority, randomised controlled trial

BACKGROUND: Coronary artery disease is common in patients undergoing transcatheter aortic valve implantation (TAVI). We aimed to assess whether deferral of percutaneous coronary intervention (PCI) is non-inferior to routine PCI before TAVI in patients with coronary artery disease. METHODS: In this investigator-initiated, open-label, randomised controlled trial, done at 12 hospitals in the Netherlands, TAVI patients with coronary artery disease were randomly assigned in a 1:1 ratio to deferral of PCI or PCI before TAVI. Randomisation was done by use of a web-based system with random block sizes of 2 and 4, and stratification by presence of coronary artery disease involving proximal left anterior descending artery. The primary endpoint was a composite of all-cause mortality, myocardial infarction, stroke, and major bleeding at 1 year. Non-inferiority testing was done in the intention-to-treat population against the prespecified margin of 11 percentage points. The study is registered with ClinicalTrials.gov (NCT05078619) and long-term follow-up is ongoing. FINDINGS: Between Oct 7, 2021, and Nov 19, 2024, 466 patients were enrolled: 233 were assigned to deferral of PCI and 233 to PCI before TAVI. Median age was 81 years (IQR 78-84), and 166 (36%) of 466 patients were female. The primary endpoint occurred in 56 (24%) of 233 patients in the deferral group as compared with 60 (26%) of 233 patients in the PCI group (rate difference -1·7% 95% CI -9·5 to 6·2; hazard ratio 0·89 95% CI 0·62-1·28; p=0·0008 for non-inferiority; p=0·68 for superiority). INTERPRETATION: In patients with coronary artery disease undergoing TAVI, deferral of PCI was non-inferior to PCI before TAVI for the 1-year composite of all-cause mortality, myocardial infarction, stroke, and major bleeding. These findings suggest that an initial conservative strategy can be appropriate in selected patients, although patient-tailored treatment decisions remain essential. FUNDING: ZonMw.