PRO-TAVI: PCI Deferral Noninferior to PCI Before TAVR at 1 Year

April 1, 2026—Deferring percutaneous coronary intervention (PCI) until after transcatheter aortic valve replacement (TAVR) resulted in similar 1-year clinical outcomes compared with performing PCI before TAVR in older patients with severe aortic stenosis (AS) and coronary artery disease (CAD), according to results of the PRO-TAVI trial presented at ACC.26 and simultaneously published in The Lancet.

The Netherlands-based, open-label, investigator-initiated PRO-TAVI trial randomized 466 patients (median age, 81 years; 36% women) with severe AS and substantial CAD to PCI before TAVR (n = 233) or TAVR first with PCI after only if clinically indicated (n = 233). The median Society of Thoracic Surgeons Predicted Risk of Mortality score was 3.1%, and the median SYNTAX score was 10, reflecting a predominantly intermediate- to high-risk population.

At 1 year, the primary composite endpoint of all-cause death, myocardial infarction, stroke, or moderate to severe bleeding occurred in 24% of the deferral group versus 26% of the PCI-first group (hazard ratio, 0.89; P = .0008 for noninferiority; P = .68 for superiority). According to the investigators, this met the prespecified threshold for noninferiority.

In the deferral arm, 11% of patients ultimately underwent PCI after TAVR because of persistent or worsening symptoms. Despite similar primary outcomes, major bleeding was significantly more frequent in the PCI-first group (15% vs 6%), which investigators attributed to the use of dual antiplatelet therapy after PCI. There was no associated increase in mortality related to bleeding events.

“This study is about intermediate- and high-risk patients only,” said lead author Michiel Voskuil, MD. “For low-risk [TAVR] patients who are generally younger, this question remains open to discussion, and there is room for new trials to determine what is the more favorable approach.”

In an accompanying editorial, Philippe Garot, MD, MSc, FACC, and Mariama Akodad, MD, wrote, “In a population with a mean age above 80 years, this reduction in hemorrhagic events is clinically meaningful. Nevertheless, PRO-TAVI should not be interpreted as evidence that PCI is unnecessary in all patients undergoing TAVR.”

The findings contribute to ongoing debate regarding the timing and necessity of coronary revascularization in patients undergoing TAVR, particularly in regions such as Europe where the procedure is commonly performed in older populations.