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PRO-TAVI Study Finds Pre-TAVR PCI Timing Equivalent for Older Patients

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PRO-TAVI Study: PCI Timing Before TAVR Shows Comparable Outcomes in Older CAD Patients

The PRO-TAVI study revealed that older patients with coronary artery disease (CAD) scheduled for transcatheter aortic valve replacement (TAVR) experienced comparable outcomes regardless of whether they underwent percutaneous coronary intervention (PCI) before TAVR. These significant findings were presented at the American College of Cardiology's Annual Scientific Session (ACC.26).

The PRO-TAVI study concludes that for older TAVR patients with CAD, the timing of PCI—either before or deferred until after TAVR—yields equivalent overall clinical outcomes.

Understanding the Procedures

Transcatheter Aortic Valve Replacement (TAVR)

TAVR is a minimally invasive procedure that implants a new aortic valve via a catheter, typically accessed through the femoral artery.

Percutaneous Coronary Intervention (PCI)

PCI, also known as angioplasty, is a minimally invasive procedure utilizing a catheter to deliver a stent. This process commonly uses the radial artery to open blocked coronary arteries and restore vital blood flow to the heart muscle.

Background and Varied Global Practices

For patients suffering from both a malfunctioning aortic valve and coronary artery disease (CAD), the optimal combination and timing of TAVR and PCI have historically lacked clear guidelines, resulting in diverse medical practices worldwide.

Regional approaches differ significantly:

  • In Europe, TAVR is frequently reserved for older, higher-risk patients. Consequently, physicians often choose to defer PCI until after the TAVR procedure.
  • In the United States, TAVR patients are typically younger and healthier. Here, the common recommendation is to perform PCI before TAVR.

PRO-TAVI Study Design and Key Findings

Study Design

The PRO-TAVI trial, conducted in the Netherlands from 2021 to 2024, included 466 patients across 12 sites. Participants, with a median age over 80 years and 36% women, represented a high-risk population characteristic of TAVR patients in Europe. All enrolled patients had significant coronary artery blockage.

Patients were randomized into two groups:

  • Group 1: Received PCI before TAVR.
  • Group 2: Received TAVR first, with PCI performed afterward only if clinically necessary due to symptoms.

Primary Outcome: Comparable Safety and Efficacy

The primary endpoint for the study was a composite of death from any cause, heart attack, stroke, or moderate to severe bleeding at 12 months.

  • PCI-before-TAVR group: 25.8% experienced the primary endpoint.
  • Deferred-PCI group: 24.1% experienced the primary endpoint.

This outcome met the non-inferiority threshold, unequivocally demonstrating that both strategies—PCI before TAVR or deferred PCI—yielded equivalent expected clinical outcomes over 12 months.

Secondary Analysis: Bleeding Rates

A notable finding from the secondary analysis was a significant difference in major bleeding rates:

  • PCI-before-TAVR group: 14.8% experienced major bleeding.
  • Deferred-PCI group: 6.2% experienced major bleeding.

Researchers attributed this increased bleeding risk in the PCI-before-TAVR group to the dual antiplatelet therapy prescribed after PCI, with the majority of bleeding events occurring around the TAVR procedure. Importantly, no excess mortality was linked to these major bleeding events.

It was observed that approximately 10% of patients in the deferred-PCI group eventually required PCI due to persistent or worsening symptoms after TAVR.

Implications and Future Directions

Dr. Michiel Voskuil, lead author and interventional cardiologist at University Medical Center Utrecht, offered clear guidance:

"For elderly TAVR patients with CAD, it appears safe to perform TAVR first and then consider PCI only if chest pain or tightness complaints persist."

Researchers emphasized that these findings are primarily relevant to elderly TAVR populations, typical of the European context. The applicability of these results to younger, healthier TAVR patient groups in other regions may be limited.

The optimal approach for low-risk, younger TAVR patients remains an open question, necessitating further dedicated trials.

Funding and Publication

The PRO-TAVI study received funding from The Netherlands Organisation for Health Research and Development (ZonMw) and was simultaneously published online in The Lancet.