Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial

Coronary Artery Disease Clinical Trial

— TAVI-PCI  

Official title:

Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04310046
• Other study ID #: TAVI PCI
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• PCI
• TAVI

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