Aortic Stenosis, Coronary Artery Disease, PCI, TAVI
Conditions
Keywords
Aortic Stenosis, Transcatheter Aortic Valve Replacement, Percutaneous Coronary Intervention, Heart Diseases, Valvular Disease, Coronary Artery Disease, Myocardial Ischemia, Cardiovascular Diseases, Vascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases
Brief 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®.
Detailed 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.
Interventions
PROCEDUREPCI 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.
PROCEDUREPCI 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.
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome measure is the number of participants experiencing the primary outcome measure | 1 year | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome measure | Discharge (hospitalization first and second procedure), 3 months, 2 years and 5 years | — |
| Single components of the primary endpoint | Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years | — |
| All cause death and myocardial infarction | Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years | — |
| Cardiovascular death and myocardial infarction | Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years | — |
| All cause death, myocardial infarction and ischemia-driven revascularization | Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years | — |
| 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 | — |
| Cardiovascular death | Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years | — |
| Stroke | Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years | — |
| Peri-procedural myocardial infarction (PCI) | Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years | — |
| Peri-procedural myocardial infarction (TAVI) | Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years | — |
| Major vascular complications | Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years | — |
| Bleeding events | Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years | Bleeding events are defined according to the Bleeding Academic Research Consortium (BARC) definition |
| 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 | — |
| Quality of life (as assessed by the KCCQ and TASQ questionnaires) | Admission (for second procedure), 3 months, 1 year, 2 years and 5 years | Kansas City Cardiomyopathy questionnaire (KCCQ) and the Toronto Aortic Stenosis Quality of Life questionnaire (TASQ) |
| Change from baseline in Quality of life (as assessed by the KCCQ and TASQ questionnaires) | Admission (for second procedure), 3 months, 1 year, 2 years and 5 years | Kansas City Cardiomyopathy questionnaire (KCCQ) and the Toronto Aortic Stenosis Quality of Life questionnaire (TASQ) |
Countries
Austria, France, Germany, Italy, Netherlands, Switzerland
Contacts
PRINCIPAL_INVESTIGATORMarkus Kasel, MD
University Hospital, Zürich
PRINCIPAL_INVESTIGATORBarbara E. Stähli, MD, eMBA
University Hospital, Zürich
Outcome results
None listed