Back to resultsOptimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial (TAVI-PCI)
Primary Purpose
Aortic Stenosis, Coronary Artery Disease, TAVI
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
PCI before TAVI
PCI after TAVI
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Stenosis focused on measuring 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
Eligibility Criteria
Inclusion Criteria:
- 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.
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:
- Dyspnea
- Angina symptoms
- Syncope
- 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.
- At least one coronary artery lesion with 40-90% diameter stenosis and iwFR (or a comparable resting index) ≤0.89 or with >90% 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.
- Written informed consent.
Exclusion Criteria:
- TAVI by transapical, subclavian, or transaortic access
- Admission with acute myocardial infarction within 30 days before randomization
- Elective coronary revascularization within 3 months before randomization
- Previous coronary artery bypass grafting (CABG)
- Syntax Score I ≥33
- Any contraindications for dual antiplatelet therapy with aspirin and a P2Y12 inhibitor (clopidogrel, ticagrelor or prasugrel), except for patients on oral anticoagulation
- Planned open heart surgery
- Known pregnancy at the time of inclusion
- Life expectancy <1 year due to other severe non-cardiac disease
- Participation in another clinical study with an investigational product
- Acute COVID-19 infection
- Patient with previously treated aortic stenosis
Sites / Locations
- University Hospital Zürich, Cardiology DepartmentRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
PCI before TAVI
PCI after TAVI
Arm Description
PCI is performed within 1-45 days before TAVI.
PCI is performed within 1-45 days after TAVI.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
The primary outcome measure
Single components of the primary endpoint
All cause death and myocardial infarction
Cardiovascular death and myocardial infarction
All cause death, myocardial infarction and ischemia-driven revascularization
All cause death, myocardial infarction, ischemia-driven revascularization and rehospitalization
Cardiovascular death
Stroke
Peri-procedural myocardial infarction (PCI)
Peri-procedural myocardial infarction (TAVI)
Major vascular complications
Bleeding events
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)
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)
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)
Full Information
NCT ID
NCT04310046
First Posted
February 12, 2020
Last Updated
October 5, 2021
Sponsor
University of Zurich
1. Study Identification
Unique Protocol Identification Number
NCT04310046
Brief Title
Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial
Acronym
TAVI-PCI
Official Title
Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2020 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 instantaneous wave-free ratio (iwFR)-guided complete revascularization performed after (within 1-45 days) with iwFR-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, consecutive 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: iwFR-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, suitable lesions with iwFR≤0.89 or >90% diameter stenosis on coronary angiography in a coronary artery ≥2.5 mm in diameter are considered significant.
TAVI and PCI will be performed according to current guidelines.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
986 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PCI before TAVI
Arm Type
Other
Arm Description
PCI is performed within 1-45 days before TAVI.
Arm Title
PCI after TAVI
Arm Type
Experimental
Arm Description
PCI is performed within 1-45 days after TAVI.
Intervention Type
Procedure
Intervention Name(s)
PCI before TAVI
Intervention Description
TAVI is performed using the Edwards SAPIEN Transcatheter Heart Valve®. PCI is performed in any suitable lesion with iwFR≤0.89 or >90% diameter stenosis on coronary angiography in a coronary artery ≥2.5 mm in diameter.
Intervention Type
Procedure
Intervention Name(s)
PCI after TAVI
Intervention Description
TAVI is performed using the Edwards SAPIEN Transcatheter Heart Valve®. PCI is performed in any suitable lesion with iwFR≤0.89 or >90% diameter stenosis on coronary angiography in a coronary artery ≥2.5 mm in diameter.
Primary Outcome Measure Information:
Title
The primary outcome measure is the number of participants experiencing the primary outcome measure
Description
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)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The primary outcome measure
Time Frame
Discharge (hospitalization first and second procedure), 3 months, 2 years and 5 years
Title
Single components of the primary endpoint
Time Frame
Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Title
All cause death and myocardial infarction
Time Frame
Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Title
Cardiovascular death and myocardial infarction
Time Frame
Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Title
All cause death, myocardial infarction and ischemia-driven revascularization
Time Frame
Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Title
All cause death, myocardial infarction, ischemia-driven revascularization and rehospitalization
Time Frame
Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Title
Cardiovascular death
Time Frame
Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Title
Stroke
Time Frame
Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Title
Peri-procedural myocardial infarction (PCI)
Time Frame
Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Title
Peri-procedural myocardial infarction (TAVI)
Time Frame
Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Title
Major vascular complications
Time Frame
Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Title
Bleeding events
Description
Bleeding events are defined according to the Bleeding Academic Research Consortium (BARC) definition
Time Frame
Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Title
Symptom status and change from baseline in symptom status (Canadian Cardiovascular Society (CCS) and New York Hear Association (NYHA) classification)
Time Frame
Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Title
Quality of life (as assessed by the KCCQ and TASQ questionnaires)
Description
Kansas City Cardiomyopathy questionnaire (KCCQ) and the Toronto Aortic Stenosis Quality of Life questionnaire (TASQ)
Time Frame
Admission (for second procedure), 3 months, 1 year, 2 years and 5 years
Title
Change from baseline in Quality of life (as assessed by the KCCQ and TASQ questionnaires)
Description
Kansas City Cardiomyopathy questionnaire (KCCQ) and the Toronto Aortic Stenosis Quality of Life questionnaire (TASQ)
Time Frame
Admission (for second procedure), 3 months, 1 year, 2 years and 5 years
Other Pre-specified Outcome Measures:
Title
Procedural success (PCI)
Time Frame
Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Title
Device success (TAVI)
Time Frame
Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Title
Change in resting and hyperemic indices for functional coronary lesion assessment from baseline to post TAVI
Time Frame
Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Title
Any revascularization
Time Frame
Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Title
Target lesion revascularization
Time Frame
Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Title
Target vessel revascularization
Time Frame
Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Title
In-stent thrombosis
Time Frame
Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Title
Acute kidney injury
Time Frame
Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Title
New-onset atrial fibrillation
Time Frame
Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Title
New permanent pacemaker implantation
Time Frame
Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Title
Aortic valve-related dysfunction requiring repeat procedure
Time Frame
Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Title
Amount of contrast medium (PCI)
Time Frame
Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Title
Fluoroscopy time (PCI)
Time Frame
Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Title
Radiation exposure (dose area product, PCI)
Time Frame
Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Title
Conversion to open heart surgery
Time Frame
Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Title
Use of catecholamines during PCI
Time Frame
Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Title
Use of catecholamines during TAVI
Time Frame
Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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:
Dyspnea
Angina symptoms
Syncope
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.
At least one coronary artery lesion with 40-90% diameter stenosis and iwFR (or a comparable resting index) ≤0.89 or with >90% 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.
Written informed consent.
Exclusion Criteria:
TAVI by transapical, subclavian, or transaortic access
Admission with acute myocardial infarction within 30 days before randomization
Elective coronary revascularization within 3 months before randomization
Previous coronary artery bypass grafting (CABG)
Syntax Score I ≥33
Any contraindications for dual antiplatelet therapy with aspirin and a P2Y12 inhibitor (clopidogrel, ticagrelor or prasugrel), except for patients on oral anticoagulation
Planned open heart surgery
Known pregnancy at the time of inclusion
Life expectancy <1 year due to other severe non-cardiac disease
Participation in another clinical study with an investigational product
Acute COVID-19 infection
Patient with previously treated aortic stenosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara E. Stähli, MD, eMBA
Phone
+41 44 255 11 11
Email
Barbara.Staehli@usz.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Markus Kasel, MD
Email
markus.kasel@usz.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Kasel, MD
Organizational Affiliation
University Hospital, Zürich
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Barbara E. Stähli, MD, eMBA
Organizational Affiliation
University Hospital, Zürich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zürich, Cardiology Department
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara E. Stähli, MD, eMBA
Email
barbara.staehli@usz.ch
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial
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