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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04310046
Other study ID # TAVI PCI
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 30, 2020
Est. completion date July 2031

Study information

Verified date December 2023
Source University of Zurich
Contact Barbara E. Stähli, MD, eMBA
Phone +41 44 255 11 11
Email Barbara.Staehli@usz.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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®.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 986
Est. completion date July 2031
Est. primary completion date July 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Procedure:
PCI before TAVI
TAVI is performed using the Edwards SAPIEN Transcatheter Heart Valve®. PCI is performed in any suitable lesion with =70% diameter stenosis on coronary angiography in a coronary artery =2.5 mm in diameter.
PCI after TAVI
TAVI is performed using the Edwards SAPIEN Transcatheter Heart Valve®. PCI is performed in any suitable lesion with =70% diameter stenosis on coronary angiography in a coronary artery =2.5 mm in diameter.

Locations

Country Name City State
Switzerland University Hospital Zürich, Cardiology Department Zürich

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Other Procedural success (PCI) Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Other Device success (TAVI) Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Other Any revascularization Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Other Target lesion revascularization Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Other Target vessel revascularization Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Other In-stent thrombosis Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Other Acute kidney injury Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Other New-onset atrial fibrillation Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Other New permanent pacemaker implantation Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Other Aortic valve-related dysfunction requiring repeat procedure Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Other Amount of contrast medium (PCI) Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Other Fluoroscopy time (PCI) Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Other Radiation exposure (dose area product, PCI) Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Other Conversion to open heart surgery Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Other Use of catecholamines during PCI Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Primary The primary outcome measure is the number of participants experiencing the primary outcome measure The primary outcome measure is a composite of:
All-cause death
Non-fatal myocardial infarction
Ischemia-driven revascularization
Rehospitalization (valve- or procedure-related including heart failure)
Life-threatening/disabling or major bleeding (according to VARC-2)
1 year
Secondary The primary outcome measure Discharge (hospitalization first and second procedure), 3 months, 2 years and 5 years
Secondary Single components of the primary endpoint Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Secondary All cause death and myocardial infarction Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Secondary Cardiovascular death and myocardial infarction Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Secondary All cause death, myocardial infarction and ischemia-driven revascularization Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Secondary All cause death, myocardial infarction, ischemia-driven revascularization and rehospitalization Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Secondary Cardiovascular death Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Secondary Stroke Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Secondary Peri-procedural myocardial infarction (PCI) Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Secondary Peri-procedural myocardial infarction (TAVI) Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Secondary Major vascular complications Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Secondary Bleeding events Bleeding events are defined according to the Bleeding Academic Research Consortium (BARC) definition Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Secondary Symptom status and change from baseline in symptom status (Canadian Cardiovascular Society (CCS) and New York Hear Association (NYHA) classification) Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Secondary Quality of life (as assessed by the KCCQ and TASQ questionnaires) Kansas City Cardiomyopathy questionnaire (KCCQ) and the Toronto Aortic Stenosis Quality of Life questionnaire (TASQ) Admission (for second procedure), 3 months, 1 year, 2 years and 5 years
Secondary Change from baseline in Quality of life (as assessed by the KCCQ and TASQ questionnaires) Kansas City Cardiomyopathy questionnaire (KCCQ) and the Toronto Aortic Stenosis Quality of Life questionnaire (TASQ) Admission (for second procedure), 3 months, 1 year, 2 years and 5 years
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