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

Launched by UNIVERSITY OF ZURICH · Mar 12, 2020

Keywords

ClinConnect Summary

The TAVI PCI Trial is studying the best timing for two important heart procedures in patients who have severe aortic stenosis (narrowing of the heart valve) and coronary artery disease (blockages in the heart's blood vessels). Specifically, the trial aims to find out whether it's safer and more effective to perform a procedure that opens the blocked arteries (called percutaneous coronary intervention or PCI) before or after the replacement of the aortic valve using a special device called the Edwards SAPIEN Transcatheter Heart Valve.

To be eligible for this study, participants must be at least 18 years old and have been diagnosed with severe aortic stenosis along with significant coronary artery blockages. They will need to provide written consent to participate. Throughout the trial, participants will be closely monitored to assess their health and the outcomes of the procedures. This research could help doctors determine the best approach for treating patients with these specific heart conditions, ultimately aiming to improve patient care and recovery.

Gender

ALL

Eligibility 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