TAVI with Deferred vs Upfront PCI: Study reveals Comparable Outcomes
The randomized PRO-TAVI trial showed that in patients with coronary artery disease undergoing transcatheter aortic valve implantation (TAVI), a deferred strategy, waiting to assess the need for percutaneous coronary intervention (PCI), resulted in outcomes similar to performing PCI upfront with TAVI. This supports a selective, wait-and-see approach to coronary intervention in these patients. The study was published in The Lancet by Prof. Ronak D. and colleagues.
PCI deferral is non-inferior to routine preprocedural PCI in patients with CAD undergoing transcatheter aortic valve implantation and supports a conservative approach in these patients. Coronary artery disease is a common finding among patients undergoing TAVI. Routine preprocedural PCI is a common approach among these patients despite a lack of strong evidence. This study aimed to assess whether a conservative approach could yield comparable outcomes by deferring PCI. The study showed that a conservative approach does not impair safety and efficacy after 1 year.
This was an investigator-initiated, open-label, randomized controlled trial conducted in 12 hospitals in the Netherlands. The patients undergoing TAVI with existing coronary artery disease were randomized in a 1:1 ratio to either PCI deferral or PCI before TAVI.
From October 7, 2021, to November 19, 2024, a total of 466 patients were included in the study, with 233 patients in each group. The patients had a median age of 81 years (IQR 78-84), indicating an elderly population with a high risk, and 166 patients (36%) were female. Randomization was stratified based on the presence of coronary artery disease involving the proximal left anterior descending artery.
Key findings:
A total of 466 patients were randomized, with 233 in each group.
The primary composite endpoint occurred in 56 patients (24%) in the PCI deferral group and 60 patients (26%) in the PCI group.
The absolute rate difference was −1.7% (95% CI −9.5 to 6.2).
The hazard ratio was 0.89 (95% CI 0.62–1.28).
Noninferiority was achieved (p = 0.0008), while superiority was not demonstrated (p = 0.68).
Deferral of PCI is noninferior to routine PCI before TAVI for major clinical outcomes at 1 year, supporting a conservative and individualized revascularization strategy in patients with coronary artery disease undergoing TAVI.
Reference:
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. https://doi.org/10.1016/s0140-6736(26)00308-9
