Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial

  • STATUS
    Recruiting
  • End date
    Jul 15, 2028
  • participants needed
    986
  • sponsor
    University of Zurich
Updated on 15 October 2021
angiography
stenosis
coronary artery disease
ejection fraction
angina pectoris
percutaneous coronary intervention
exercise stress test
transcatheter aortic valve implantation
tavi
symptomatic aortic stenosis
arterial disease
syncope
revascularisation

Summary

The primary objective of this study is to compare, in patients with severe aortic stenosis and concomitant coronary artery disease accepted for transcatheter aortic valve implantation (TAVI) and percutaneous coronary intervention (PCI) by the multidisciplinary Heart Team, the safety and efficacy of instantaneous wave-free ratio (iwFR)-guided complete revascularization performed after (within 1-45 days) with iwFR-guided complete revascularization performed before (within 1-45 days) TAVI using the Edwards SAPIEN Transcatheter Heart Valve.

Description

The prevalence of coronary artery disease in patients with severe aortic stenosis is high. About 30-60% of patients undergoing TAVI exhibit coexisting coronary artery disease. Optimal timing of coronary revascularization in patients with severe aortic stenosis and concomitant coronary artery disease undergoing TAVI is uncertain.

The goal of this investigator-initiated, randomized, multicenter, two-arm, open-label, non-inferiority trial is to compare two treatment strategies that are currently performed in clinical practice: PCI before TAVI versus PCI after TAVI in patients with severe aortic stenosis and concomitant coronary artery disease.

In this trial, consecutive patients with severe aortic stenosis and concomitant coronary artery disease accepted for TAVI and PCI by the Heart Team will be randomized in a 1:1 ratio to the following strategies: iwFR-guided complete coronary revascularization before (within 1-45 days) or after (within 1-45 days) TAVI using the Edwards SAPIEN Transcatheter Heart Valve.

For both treatment groups, suitable lesions with iwFR0.89 or >90% diameter stenosis on coronary angiography in a coronary artery 2.5 mm in diameter are considered significant.

TAVI and PCI will be performed according to current guidelines.

Details
Condition Protein C Inhibitor, transcatheter aortic valve implant, Cardiac Ischemia, VALVULAR HEART DISEASE, Myocardial Ischemia, prophylactic cranial irradiation, TAVI, Aortic Stenosis, Coronary Artery Disease, aortic valve stenosis, Heart Valve Disease, Percutaneous Coronary Intervention, Coronary heart disease
Treatment PCI after TAVI, PCI before TAVI
Clinical Study IdentifierNCT04310046
SponsorUniversity of Zurich
Last Modified on15 October 2021

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