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

Last updated: December 14, 2023
Sponsor: University of Zurich
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hypercholesterolemia

Heart Disease

Thrombosis

Treatment

PCI before TAVI

PCI after TAVI

Clinical Study ID

NCT04310046
TAVI PCI
  • Ages > 18
  • All Genders

Study 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 angiography-guided complete revascularization performed after (within 1-45 days) with angiography-guided complete revascularization performed before (within 1-45 days) TAVI using the Edwards SAPIEN Transcatheter Heart Valve®.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients ≥18 years with severe aortic stenosis and concomitant coronary artery diseaseaccepted for transfemoral TAVI with an Edwards SAPIEN Transcatheter Heart Valve™ andPCI by a multidisciplinary Heart Team.
  2. Severe aortic stenosis defined as aortic valve area (AVA) ≤1.0 cm2 and/or meanpressure gradient ≥40 mmHg (echocardiography) and at least one of the followingcriteria:
  3. Dyspnea
  4. Angina symptoms
  5. Syncope
  6. Decline in left ventricular ejection fraction <50%, symptoms or fall in bloodpressure on exercise testing, or presence of high-risk criteria (peak transaorticvelocity >5.5 m/s, severe valve calcification, peak transaortic velocityprogression ≥0.3 m/s per year, or severe pulmonary hypertension with systolicpulmonary artery pressure >60 mmHg) according to current guidelines.
  7. At least one coronary artery lesion with ≥70% diameter stenosis on coronary angiogram (by visual estimation) in a coronary artery ≥2.5 mm in diameter and Thrombolysis inMyocardial Infarction (TIMI) flow grade III, deemed amenable to PCI within 45 daysbefore or after TAVI. Hemodynamic lesion assessment by fractional flow reserve (FFR),instantaneous wave-free ratio (iwFR), or comparable indices as well as intravascularimaging-guided PCI are left at the discretion of the operator.
  8. Written informed consent.

Exclusion

Exclusion Criteria:

  1. TAVI by transapical, subclavian, or transaortic access
  2. Admission with acute myocardial infarction within 30 days before randomization
  3. Elective coronary revascularization within 3 months before randomization
  4. Previous coronary artery bypass grafting (CABG)
  5. Syntax Score I ≥33
  6. Any contraindications for dual antiplatelet therapy with aspirin and a P2Y12 inhibitor (clopidogrel, ticagrelor or prasugrel), except for patients on oral anticoagulation
  7. Planned open heart surgery
  8. Known pregnancy at the time of inclusion
  9. Life expectancy <1 year due to other severe non-cardiac disease
  10. Participation in another clinical study with an investigational product
  11. Acute COVID-19 infection
  12. Patient with previously treated aortic stenosis

Study Design

Total Participants: 986
Treatment Group(s): 2
Primary Treatment: PCI before TAVI
Phase:
Study Start date:
September 30, 2020
Estimated Completion Date:
July 31, 2031

Study 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, 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: angiography-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, coronary artery lesions with ≥70% diameter stenosis on coronary angiogram (by visual estimation) in a coronary artery ≥2.5 mm in diameter are considered significant.

TAVI and PCI will be performed according to current guidelines.

Connect with a study center

  • University Hospital Zürich, Cardiology Department

    Zürich, 8091
    Switzerland

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.