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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2024
• Main ID: NCT04310046
• Date of registration: 12/02/2020
• Prospective Registration: Yes
• Primary sponsor: University of Zurich
• Public title: Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial TAVI-PCI
• Scientific title: Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial
• Date of first enrolment: September 30, 2020
• Target sample size: 986
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT04310046
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Switzerland

Contacts

• Name: Barbara E. Stähli, MD, eMBA

• Name: Barbara E. Stähli, MD, eMBA

• Name: Markus Kasel, MD
• Affiliation: University Hospital, Zürich

• Name: Barbara E. Stähli, MD, eMBA
• Affiliation: University Hospital, Zürich

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Coronary Artery Disease

Aortic Stenosis

PCI

TAVI

Intervention(s)

Procedure: PCI after TAVI

Procedure: PCI before TAVI

Primary Outcome(s)

The primary outcome measure is the number of participants experiencing the primary outcome measure [Time Frame: 1 year]

Secondary Outcome(s)

Cardiovascular death and myocardial infarction [Time Frame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years]

Change from baseline in Quality of life (as assessed by the KCCQ and TASQ questionnaires) [Time Frame: Admission (for second procedure), 3 months, 1 year, 2 years and 5 years]

Peri-procedural myocardial infarction (PCI) [Time Frame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years]

All cause death and myocardial infarction [Time Frame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years]

Cardiovascular death [Time Frame: 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) [Time Frame: Admission (for second procedure), 3 months, 1 year, 2 years and 5 years]

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]

The primary outcome measure [Time Frame: Discharge (hospitalization first and second procedure), 3 months, 2 years and 5 years]

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]

Peri-procedural myocardial infarction (TAVI) [Time Frame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years]

Single components of the primary endpoint [Time Frame: 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 [Time Frame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years]

Bleeding events [Time Frame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years]

Major vascular complications [Time Frame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years]

Stroke [Time Frame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years]

Secondary ID(s)

TAVI PCI

Source(s) of Monetary Support

Please refer to primary and secondary sponsors