Older patients with coronary artery disease scheduled for transcatheter aortic valve replacement (TAVR) had comparable outcomes regardless of whether they underwent percutaneous coronary intervention (PCI) before TAVR, according to findings from the PRO-TAVI study presented at the American College of Cardiology's Annual Scientific Session (ACC.26).
TAVR is a minimally invasive procedure in which a new aortic valve is delivered via a catheter, most commonly through the femoral artery in the groin, and implanted within the diseased native valve. PCI, also called angioplasty, is a minimally invasive procedure in which a stent is delivered via a catheter, typically through the radial artery in the arm, to open narrowed or blocked coronary arteries and restore adequate blood flow to the heart muscle.
For patients who have both a malfunctioning valve and blocked arteries (coronary artery disease), there has been a lack of evidence regarding the optimal combination and timing of procedures, and common practices vary by region. In Europe, where TAVR is largely reserved for older and higher-risk patients, physicians have tended to defer PCI until after TAVR. In the United States, where patients undergoing TAVR tend to be younger and healthier, it is more common to recommend patients undergo PCI before TAVR.
The trial was conducted in the Netherlands, and the findings support the common practice there, where physicians prefer to omit PCI before TAVR unless there is a clear indication that PCI is necessary. According to the results, omitting PCI before TAVR did not result in any increase in the risk of death, heart attack, stroke or moderate to serious bleeding.
For elderly TAVR patients with concomitant coronary artery disease, I think it's safe to first do TAVR and see if patients will still have complaints about chest pain or tightness. We can wait and, if they still have complaints afterward, only then do PCI."
Michiel Voskuil, MD, PhD, interventional cardiologist and professor at University Medical Center Utrecht in the Netherlands and the study's lead author
The trial enrolled 466 patients at 12 sites in the Netherlands between 2021-2024. The median age of participants was over 80 years, 36% were women, and patients overall reflected a high-risk population, typical for patients undergoing TAVR in Europe. All participants had coronary artery disease with significant blockage in the arteries. Half of the patients were randomly assigned to receive PCI before their TAVR procedure, and half were assigned to receive TAVR first and only undergo PCI afterward if necessary.
The primary endpoint was a composite of death from any cause, heart attack, stroke or moderate to severe bleeding at 12 months. This composite endpoint occurred in 25.8% of those who underwent PCI before TAVR and 24.1% of those who deferred PCI. This result met the trial's prespecified threshold for non-inferiority and did not demonstrate the superiority of either approach, indicating that they are equivalent in terms of expected outcomes.
The two study groups did show a significant difference in the rate of major bleeding, which was analyzed as a secondary outcome. Among those who underwent PCI before TAVR, 14.8% experienced major bleeding, compared with 6.2% of those who deferred PCI. Researchers said this increase in bleeding was likely attributable to the dual antiplatelet therapy that is prescribed following PCI and most bleeds occurred around the time of the TAVR procedure, although there was no excess mortality associated with major bleeding.
Overall, about 10% of patients who were assigned to defer PCI eventually underwent PCI due to continuing or worsening symptoms following their TAVR.
Researchers said the results are most applicable to Europe and the Netherlands in particular, where TAVR is generally used in an elderly population. The findings may not necessarily translate to other countries and populations where it is more common for younger and relatively healthier patients to undergo TAVR.
"This study is about intermediate and high-risk patients only," Voskuil said. "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."
The study was funded by The Netherlands Organisation for Health Research and Development (ZonMw).
This study was simultaneously published online in The Lancet at the time of presentation.
Voskuil will present the study, "Transcatheter Aortic Valve Implantation Without Routine Percutaneous Coronary Intervention: A Randomized Controlled Trial," on Sunday, March 29, at 4:00 p.m. CT / 21:00 UTC in the Main Tent, Great Hall.
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