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Deferring PCI Before TAVI Shows Non-Inferiority at One Year in Coronary Artery Disease Patients
In a multicentre randomised controlled trial of 466 patients, deferring percutaneous coronary intervention (PCI) was non-inferior to performing routine PCI before transcatheter aortic valve implantation (TAVI) for a one-year composite of all-cause mortality, myocardial infarction, stroke, and major bleeding (24% vs 26%; HR 0.89, 95% CI 0.62–1.28; p=0.0008 for non-inferiority). The observed difference in event rates was small and the confidence interval wide, indicating that the two strategies produced broadly similar outcomes at one year, though the trial was not powered to demonstrate superiority of either approach.
What Was Studied
The PRO-TAVI trial investigated whether deferring PCI — that is, withholding coronary revascularisation before valve replacement — is non-inferior to the conventional strategy of performing PCI prior to TAVI in patients with concurrent coronary artery disease. The primary outcome was a composite of all-cause mortality, myocardial infarction, stroke, and major bleeding at one year, with a prespecified non-inferiority margin of 11 percentage points.
How It Was Studied
This was an investigator-initiated, open-label, non-inferiority randomised controlled trial conducted across 12 hospitals in the Netherlands. A total of 466 patients with coronary artery disease who were already scheduled to undergo TAVI were enrolled between October 2021 and November 2024, with a median age of 81 years (IQR 78–84) and 36% female representation. Participants were randomly assigned in a 1:1 ratio to either deferral of PCI or PCI performed before TAVI, with randomisation stratified by the presence of coronary artery disease involving the proximal left anterior descending artery. The primary analysis was conducted in the intention-to-treat population, and long-term follow-up beyond one year remains ongoing.
What Was Observed
- The primary composite endpoint was reached by 24% of patients in the deferral group compared with 26% in the PCI-before-TAVI group — a difference of approximately 2 percentage points that did not cross the prespecified non-inferiority margin (rate difference −1.7%, 95% CI −9.5 to 6.2), thereby establishing non-inferiority of the deferral strategy (p=0.0008 for non-inferiority).
- The hazard ratio numerically favoured deferral, but the estimate was imprecise and entirely consistent with no meaningful difference between strategies (HR 0.89, 95% CI 0.62–1.28). The wide confidence interval reflects the moderate sample size and does not support a conclusion of superiority for either arm.
- A formal superiority test was also performed and was clearly negative (p=0.68 for superiority), confirming that deferral did not produce a statistically significant reduction in the composite endpoint compared with routine pre-TAVI PCI.
Why This Matters
Coronary artery disease is described as common among patients undergoing TAVI, making the question of whether and when to revascularise a clinically relevant procedural decision. The trial’s findings challenge the premise that PCI must routinely precede TAVI, providing direct randomised evidence that an initial conservative deferral strategy does not result in worse one-year clinical outcomes. The authors acknowledge that patient-tailored treatment decisions remain essential, suggesting the results support flexibility in procedural sequencing rather than a uniform deferral policy for all eligible patients.
How to Read This Result
This well-designed multicentre RCT establishes non-inferiority of PCI deferral within a one-year window, but the open-label design carries the potential for performance or assessment bias, and the durability of these findings beyond one year remains uncertain pending completion of ongoing long-term follow-up.
Limitations
The abstract does not explicitly report study limitations.