Clinical trial NCT04310046: Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial
Official title: Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Stenosis
Coronary Artery Disease
TAVI
PCI
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
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 986
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The primary outcome measure is the number of participants experiencing the primary outcome measure
timeFrame: 1 year
Secondary outcomes:
measure: The primary outcome measure
timeFrame: Discharge (hospitalization first and second procedure), 3 months, 2 years and 5 years
measure: Single components of the primary endpoint
timeFrame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
measure: All cause death and myocardial infarction
timeFrame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
measure: Cardiovascular death and myocardial infarction
timeFrame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
measure: All cause death, myocardial infarction and ischemia-driven revascularization
timeFrame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
measure: All cause death, myocardial infarction, ischemia-driven revascularization and rehospitalization
timeFrame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
measure: Cardiovascular death
timeFrame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
measure: Stroke
timeFrame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
measure: Peri-procedural myocardial infarction (PCI)
timeFrame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
measure: Peri-procedural myocardial infarction (TAVI)
timeFrame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
measure: Major vascular complications
timeFrame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
measure: Bleeding events
timeFrame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
measure: Symptom status and change from baseline in symptom status (Canadian Cardiovascular Society (CCS) and New York Hear Association (NYHA) classification)
timeFrame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
measure: Quality of life (as assessed by the KCCQ and TASQ questionnaires)
timeFrame: Admission (for second procedure), 3 months, 1 year, 2 years and 5 years
measure: Change from baseline in Quality of life (as assessed by the KCCQ and TASQ questionnaires)
timeFrame: Admission (for second procedure), 3 months, 1 year, 2 years and 5 years
Other outcomes:
measure: Procedural success (PCI)
timeFrame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
measure: Device success (TAVI)
timeFrame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
measure: Any revascularization
timeFrame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
measure: Target lesion revascularization
timeFrame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
measure: Target vessel revascularization
timeFrame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
measure: In-stent thrombosis
timeFrame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
measure: Acute kidney injury
timeFrame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
measure: New-onset atrial fibrillation
timeFrame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
measure: New permanent pacemaker implantation
timeFrame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
measure: Aortic valve-related dysfunction requiring repeat procedure
timeFrame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
measure: Amount of contrast medium (PCI)
timeFrame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
measure: Fluoroscopy time (PCI)
timeFrame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
measure: Radiation exposure (dose area product, PCI)
timeFrame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
measure: Conversion to open heart surgery
timeFrame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
measure: Use of catecholamines during PCI
timeFrame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Locations:
city: Zürich
country: Switzerland
facility: University Hospital Zürich, Cardiology Department
Study officials:
affiliation: University Hospital, Zürich
name: Markus Kasel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Zürich
name: Barbara E. Stähli, MD, eMBA
role: PRINCIPAL_INVESTIGATOR
References: