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

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 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.

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 1-45 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

Start Date

September 30, 2020

Completion Date

July 2028

Primary Completion Date

July 2023

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 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.

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

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 2021