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.
Summary
In 466 TAVI candidates with coronary artery disease, deferring PCI was non-inferior to routine pre-TAVI PCI for a 1-year composite of death, MI, stroke, or major bleeding. The hazard ratio was 0.89 with a non-inferiority p value of 0.0008, suggesting an initial conservative approach may be appropriate in selected patients.
Key Findings
- Deferral of PCI was non-inferior to pre-TAVI PCI for the 1-year composite endpoint (24% vs 26%; HR 0.89; non-inferiority p=0.0008).
- Randomization was stratified by proximal LAD disease; median age 81 years, reflecting real-world TAVI demographics.
- Results support initial conservative management with tailored revascularization decisions.
Clinical Implications
For TAVI candidates with stable coronary disease, routine PCI before TAVI may be avoided in favor of deferral with individualized decision-making, potentially reducing procedural complexity and bleeding risk without worsening major outcomes.
Why It Matters
This pragmatic multicenter RCT challenges the routine practice of pre-TAVI PCI, offering high-level evidence to support a conservative, anatomy-guided approach without compromising 1-year outcomes.
Limitations
- Open-label design may introduce performance bias
- Follow-up limited to 1 year; long-term ischemic risk remains to be clarified
Future Directions
Longer-term follow-up and subgroup analyses (e.g., high-risk anatomy, fractional flow reserve-guided strategies) could refine selection criteria for deferral.
Study Information
- Study Type
- RCT
- Research Domain
- Treatment
- Evidence Level
- I - Randomized controlled trial providing high-level evidence for non-inferiority.
- Study Design
- OTHER