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

Clinical Snapshot

Key Findings

• P Value: p=0.0008 for non-inferiority; p=0.68 for superiority

• Effect Size: 24% vs 26% (deferral vs PCI group)

• Primary Outcome: Composite of all-cause mortality, myocardial infarction, stroke, and major bleeding at 1 year

• Nnt Or Sensitivity: Hazard ratio 0.89 (95% CI 0.62-1.28)

• Confidence Interval: Rate difference -1.7% (95% CI -9.5 to 6.2)

Clinical Application

Highly feasible as deferral strategy reduces procedural complexity and resource utilisation Relevant to Australian practice given similar healthcare systems and TAVI programs. May influence PBS funding considerations and clinical guidelines from CSANZ Elderly patients with coronary artery disease undergoing TAVI in tertiary cardiac centres

Abstract

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.

References

1. 1.Delewi, R., Aarts, H. M., Broeze, G. M., Hemelrijk, K. I., van Ginkel, D. J., Versteeg, G. A. A., Grundeken, M. J., Claessen, B. E. P. M., Tonino, P. A. L., Schotborgh, C. E., Meuwissen, M., van Houwelingen, G. K., Wykrzykowska, J. J., Amoroso, G., Vossenberg, T. N., Vriesendorp, P. A., van Royen, N., Ten Berg, J. M., Tijssen, J. G. P., & Voskuil, M. (2026). 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. *Lancet*, *407*(10462), 1234-1242. https://doi.org/10.1016/S0140-6736(26)00308-9