[Articles] Deferral of Percutaneous Coronary Intervention in Patients Undergoing Transcatheter Aortic Valve Implantation (PRO-TAVI): An Investigator-Initiated, Multicentre, Open-Label, Non-Inferiority, Randomised Controlled Trial

Why It Matters

Demonstrating non‑inferiority of PCI deferral could reduce unnecessary invasive procedures, lower procedural risk, and cut costs, reshaping guideline recommendations for managing coronary disease in TAVI patients.

Key Takeaways

• 466 patients, 1‑year composite 24% vs 26% (deferral vs PCI).
• Non‑inferiority margin met; p‑value 0.0008.
• Hazard ratio 0.89, confidence interval 0.62–1.28.
• Median age 81, 36% female.
• Individual component events similar between groups.

Pulse Analysis

Coronary artery disease frequently co‑exists with severe aortic stenosis, creating a therapeutic dilemma for clinicians planning transcatheter aortic valve implantation (TAVI). Historically, guidelines have advocated routine pre‑procedural percutaneous coronary intervention (PCI) to mitigate ischemic risk, yet observational data have shown mixed outcomes and increased bleeding complications. The PRO‑TAVI trial, spanning twelve Dutch centres, was designed to fill this evidence gap by directly comparing a deferred PCI approach against the conventional pre‑TAVI revascularisation strategy, using a robust composite endpoint that captures mortality, myocardial infarction, stroke, and major bleeding.

The trial’s methodology emphasized rigorous randomisation, stratification by proximal left anterior descending artery disease, and an intention‑to‑treat analysis. With 466 participants averaging 81 years of age, the primary endpoint occurred in 24% of patients who deferred PCI versus 26% in those receiving PCI, yielding a hazard ratio of 0.89 and satisfying the pre‑specified non‑inferiority margin (p=0.0008). Importantly, individual component rates—such as stroke and major bleeding—were comparable, indicating that postponing PCI did not translate into heightened procedural risk or adverse cardiovascular events within the first year.

Clinically, these results challenge the prevailing notion that routine revascularisation is mandatory before TAVI. By validating a conservative strategy, the study supports a more patient‑centred approach that weighs lesion severity, frailty, and procedural complexity against the potential harms of additional interventions. Health systems may see cost savings from fewer catheterisations, while patients could benefit from reduced exposure to contrast and antithrombotic therapy. Ongoing long‑term follow‑up will clarify durability of outcomes, but the PRO‑TAVI evidence is poised to influence future ESC/EACTS and ACC/AHA guideline updates, encouraging tailored decision‑making for coronary disease in the growing TAVI population.