Older patients with coronary artery disease (CAD) for whom PCI was deferred until after TAVI had similar outcomes as those for whom it was not deferred, according to findings from the PRO-TAVI study presented in a Late-Breaking Clinical Trial session at ACC.26 in New Orleans and simultaneously published in The Lancet.

Ronak Delewi, MD, et al., conducted a Netherlands-based, open-label, investigator-initiated trial between 2021-2024 and randomized 466 high-risk, older patients (median age, 81 years; 36% women) with severe aortic stenosis and substantial CAD 1:1 to receive PCI before the TAVI procedure (n=233; PCI-first group) or receive TAVI first with PCI afterward if necessary (n=233; deferral group). Among all participants, the median Society of Thoracic Surgeons Predicted Risk of Mortality score was 3.1% and median SYNTAX CAD complexity score was 10.

In the deferral group, 11% of patients eventually underwent PCI due to continuing or worsening symptoms post TAVI.

Results showed that 56 patients (24%) in the deferral arm vs. 60 (26%) in the PCI-first arm experienced the primary endpoint, a one-year composite of death from any cause, myocardial infarction (MI), stroke or moderate to severe bleeding (hazard ratio, 0.89). This result met the trial's prespecified threshold for noninferiority (p=0.0008), with neither approach demonstrating superiority (p=0.68).

There was, however, a significant difference in secondary outcomes – specifically the rate of major bleeding. Among patients in the PCI-first arm, 15% experienced major bleeding compared with 6% in the deferral arm, which investigators attribute to the dual antiplatelet therapy prescribed following PCI. There was no excess mortality associated with the major bleeding.

Researchers found the results to be most applicable to Europe and the Netherlands specifically, where TAVI is generally used in an elderly population. "This study is about intermediate- and high-risk patients only," explains Michiel Voskuil, MD, the study's lead author. "For low-risk [TAVI] 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 a population with a mean age above 80 years, this reduction in hemorrhagic events is clinically meaningful," write Philippe Garot, MD, MSc, FACC, and Mariama Akodad, MD, in an accompanying editorial comment. "Nevertheless, PRO-TAVI should not be interpreted as evidence that PCI is unnecessary in all patients undergoing TAVI."

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Atherosclerotic Disease (CAD/PAD), Aortic Surgery, Cardiac Surgery and VHD, Interventions and Coronary Artery Disease, Interventions and Structural Heart Disease

Keywords: ACC Annual Scientific Session, ACC26, New Orleans, Transcatheter Aortic Valve Replacement, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Coronary Artery Disease, Aortic Valve Stenosis, Myocardial Infarction, Hemorrhage, Stroke