Comparing the timing of heart valve replacement and coronary artery treatment
Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial
This study tests whether doing heart artery treatment before or after a valve replacement helps people with severe aortic stenosis and coronary artery disease feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 986 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Zurich Academic / other |
| Locations | 1 site (Zürich) |
| Trial ID | NCT04310046 on ClinicalTrials.gov |
What this trial studies
This trial aims to determine the optimal timing for performing percutaneous coronary intervention (PCI) in patients with severe aortic stenosis and coronary artery disease who are undergoing transcatheter aortic valve implantation (TAVI). Patients will be randomly assigned to receive PCI either before or after TAVI, with both procedures guided by angiography. The study will evaluate the safety and efficacy of these two approaches to improve patient outcomes. The trial is designed as a multicenter, open-label, non-inferiority trial, ensuring a robust comparison of the two strategies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with severe aortic stenosis and significant coronary artery disease who are eligible for TAVI and PCI.
Not a fit: Patients without severe aortic stenosis or those who do not have significant coronary artery disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for patients with severe aortic stenosis and coronary artery disease, enhancing their overall outcomes.
How similar studies have performed: While the timing of PCI in relation to TAVI has been explored, this specific comparison of pre- versus post-TAVI PCI is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients ≥18 years with severe aortic stenosis and concomitant coronary artery disease accepted for transfemoral TAVI with an Edwards SAPIEN Transcatheter Heart Valve™ and PCI by a multidisciplinary Heart Team. 2. Severe aortic stenosis defined as aortic valve area (AVA) ≤1.0 cm2 and/or mean pressure gradient ≥40 mmHg (echocardiography) and at least one of the following criteria: 1. Dyspnea 2. Angina symptoms 3. Syncope 4. Decline in left ventricular ejection fraction \<50%, symptoms or fall in blood pressure on exercise testing, or presence of high-risk criteria (peak transaortic velocity \>5.5 m/s, severe valve calcification, peak transaortic velocity progression ≥0.3 m/s per year, or severe pulmonary hypertension with systolic pulmonary artery pressure \>60 mmHg) according to current guidelines. 3. 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 in Myocardial Infarction (TIMI) flow grade III, deemed amenable to PCI within 45 days before or after TAVI. Hemodynamic lesion assessment by fractional flow reserve (FFR), instantaneous wave-free ratio (iwFR), or comparable indices as well as intravascular imaging-guided PCI are left at the discretion of the operator. 4. Written informed consent. 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
Where this trial is running
Zürich
- University Hospital Zürich, Cardiology Department — Zürich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Markus Kasel, MD — University Hospital, Zürich
- Study coordinator: Barbara E. Stähli, MD, eMBA
- Email: Barbara.Staehli@usz.ch
- Phone: +41 44 255 11 11
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.