Brief Title
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
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 fractional flow reserve (FFR)-guided complete revascularization
performed after (within 1-40 days) with FFR-guided complete revascularization performed
before (within 1-40 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 either FFR-guided complete coronary revascularization before (within 1-40 days) or after
(within 1-40 days) TAVI using the Edwards SAPIEN Transcatheter Heart Valve®.
For both treatment groups, suitable lesions with FFR≤0.80 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.
Study Type
Interventional
Primary Outcome
The primary outcome measure is the number of participants experiencing the primary outcome measure
Secondary Outcome
The primary outcome measure
Condition
Aortic Stenosis
Intervention
PCI before TAVI
Study Arms / Comparison Groups
PCI before TAVI
Description: PCI is performed within 1-40 days before TAVI.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
986
Start Date
September 30, 2020
Completion Date
July 2023
Primary Completion Date
July 2023
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years
- Patients with severe aortic stenosis and concomitant coronary artery disease accepted
for TAVI and PCI by a multidisciplinary Heart Team
- Severe symptomatic aortic stenosis defined as aortic valve area (AVA) ≤1.0 cm2 and/or
≥40 mmHg (echocardiography) and at least one of the following:
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, and severe pulmonary hypertension with systolic
pulmonary artery pressure >60 mmHg) according to current guidelines
Exclusion Criteria:
- Inability to give informed consent
- No PCI-eligible coronary artery stenosis
- Admission with acute coronary syndromes within 30 days before randomization
- Previous coronary artery bypass grafting (CABG)
- Any contraindications for dual antiplatelet therapy with aspirin and a P2Y12
inhibitors (clopidogrel, ticagrelor, prasugrel)
- Planned cardiac or major surgery
- Known pregnancy at the time of inclusion
- Participation in another clinical study with an investigational product
- Life expectancy <1 year due to other severe non-cardiac disease
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Markus Kasel, MD, +41 44 255 11 11, [email protected]
Location Countries
Switzerland
Location Countries
Switzerland
Administrative Informations
NCT ID
NCT04310046
Organization ID
TAVI PCI
Responsible Party
Sponsor
Study Sponsor
University of Zurich
Study Sponsor
Markus Kasel, MD, Principal Investigator, University Hospital, Zürich
Verification Date
October 2020