Coronary Artery Disease Clinical Trial
— TAVI-PCIOfficial title:
Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial
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 |
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®.
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Zürich, Cardiology Department | Zürich |
Lead Sponsor | Collaborator |
---|---|
University of Zurich |
Switzerland,
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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