Valvular & structural heart diseaseRandomised controlled trial

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

LancetPublished

  • Randomised controlled trial
  • investigator-initiated
  • multicentre
  • open-label
  • non-inferiority
  • 12 hospitals in the Netherlands

Authors' conclusion

In patients with coronary artery disease undergoing TAVI, deferral of PCI was non-inferior to PCI before TAVI for the 1-year composite of all-cause mortality, myocardial infarction, stroke, and major bleeding.

Study context

Population
Transcatheter aortic valve implantation (TAVI) patients with CAD
Participants
466 patients
Comparison
Deferral of percutaneous coronary intervention (PCI) vs PCI before TAVI
  • Deferraln = 233
  • PCIn = 233reference
Primary endpoint
Composite of:
  • All-cause mortality
  • MI
  • Stroke
  • Major bleeding
Follow-up
1 year

Primary result

As reported in the abstract

Each group vs PCIRate difference (95% CI)P value
Deferral
−1.7%(−9.5 to 6.2)
P = 0.0008 for non-inferiority

Non-inferiority margin 11 as printed, not drawn

Each group vs PCIHazard ratio (95% CI)P value
Deferral
0.89(0.62–1.28)
P = 0.68 for superiority

Non-inferiority margin 11 as printed, not drawn

Original publication

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. Lancet. Published 29 March 2026. doi:10.1016/s0140-6736(26)00308-9

Summarised from the published abstract; every number is checked against it