Elderly 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 results from the PRO-TAVI study presented at the American College of Cardiology’s Annual Scientific Meeting (ACC.26).
TAVR is a minimally invasive surgery 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 through a catheter, usually through the radial artery in the arm, to open a narrowed or blocked coronary artery and restore proper blood flow to the heart muscle.
For patients with both valve dysfunction and arterial occlusion (coronary artery disease), evidence regarding the optimal combination and timing of procedures is lacking, and common practices vary by region. In Europe, TAVR is primarily restricted to older, high-risk patients, and physicians tend to postpone PCI until after TAVR. In the United States, where patients undergoing TAVR tend to be young and healthy, it is common to recommend that patients undergo PCI before undergoing TAVR.
The study was conducted in the Netherlands, and the results confirmed the common practice in the Netherlands that physicians prefer to omit PCI before TAVR unless there are clear indications that PCI is needed. The results showed that omitting PCI before TAVR did not increase the risk of death, heart attack, stroke, or moderate to severe bleeding.
For older TAVR patients with coronary artery disease, I think it is safe to perform TAVR first and see if they continue to complain of chest pain or pressure. We can wait and then only do a PCI if the complaint remains. ”
Michel Voskuil, MD, interventional cardiologist and professor at Utrecht University Medical Center in the Netherlands, and lead author of the study
The trial enrolled 466 patients at 12 centers in the Netherlands between 2021 and 2024. The median age of participants was 80 years or older, 36% were female, and overall patients reflected the high-risk population typical of patients undergoing TAVR in Europe. All participants had coronary artery disease with significant blockages in their arteries. Half of the patients were randomly assigned to undergo PCI before the TAVR procedure, and half were assigned to undergo TAVR first and then PCI only if needed.
The primary endpoint was a combination of death from any cause, heart attack, stroke, or moderate to severe bleeding at 12 months of age. This composite endpoint occurred in 25.8% of those who underwent PCI before TAVR and in 24.1% of those who deferred PCI. This result met the trial’s prespecified non-inferiority threshold, demonstrating no superiority of either approach and indicating that they are equivalent in terms of expected outcomes.
The two study groups showed significant differences in major bleeding rates, which were analyzed as a secondary outcome. Among those who underwent PCI before TAVR, 14.8% experienced major bleeding, compared with 6.2% of those who postponed PCI. The researchers said that this increased bleeding was likely due to the dual antiplatelet therapy prescribed after PCI, and that although there were no excess deaths associated with major bleeding, most bleeding occurred around the time of TAVR surgery.
Overall, approximately 10% of patients assigned to deferred PCI ultimately underwent PCI due to continued or worsening symptoms after TAVR.
The researchers said this finding is particularly true in Europe and the Netherlands, where TAVR is commonly used in older adults. The findings of this study may not necessarily apply to other countries or populations where it is common for young, relatively healthy patients to undergo TAVR.
“This study is only targeting intermediate- and high-risk patients,” Voskuil said. “For low-risk TAVR patients, who are typically younger, this issue remains controversial and there is room for new trials to determine what is the more preferable approach.”
This study was funded by the Netherlands Organization for Health Research and Development (ZonMw).
The study was published online at the same time. lancet At the time of the presentation.
Dr. Voskuil will present his study, “Transcatheter Aortic Valve Implantation (No Routine Percutaneous Coronary Intervention): A Randomized Controlled Trial,” in the Great Hall main tent on Sunday, March 29 at 4:00 PM CT/4:00 PM Universal Time.
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American College of Cardiology
