Post TAVI Coronary REVASCularisation Guided by Myocardial Perfusion Imaging: a Prospective Open Label Pilot Study: The REVASC-TAVI Study

Study Overview
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Brief Summary
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Evaluation of a strategy of selected revascularization guided on myocardial ischemia detection after the TAVI procedure by using single photon emission computed tomography (SPECT) myocardial perfusion imaging.

Detailed Description
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Background: Percutaneous coronary intervention (PCI) is usually proposed to patients with aortic stenosis (AS) before TransAortic Valve Implantation (TAVI) when significant coronary stenosis is detected on preprocedural coronary angiography. However, the benefit of a systematic revascularisation is unknown and may have specific complications in elderly and frail patients. Aims: The investigators proposed a strategy of selected revascularization guided on myocardial ischemia detection after the TAVI procedure by using single photon emission computed tomography (SPECT) myocardial perfusion imaging. Methods: This prospective open label clinical trial will include 71 consecutive patients with significant coronary artery disease (CAD) defined by one or more significant coronary stenosis in patients admitted for TAVI. Myocardial SPECT imaging will be performed in all patients at 1-month follow-up after the TAVI procedure. Targeted PCI will be performed only in patients with significant related ischemia (> 10 % myocardial perfusion defect). The primary outcome criterion is a composite criterion of feasibility and safety including all causes of death, stroke, major bleedings, major vascular complications, per procedural myocardial infarction, coronary revascularization or rehospitalisation for cardiac cause at 6 month follow-up. Hypothesis: An alternative management of CAD guided by significant myocardial ischemia detection after TAVI could reduce the risk of unnecessary revascularization, the complications and the costs inherent to these procedures and a phase II trial is requiring to the evaluate this innovative and less invasive strategy.

Conditions
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Severe and Symptomatic Aortic Stenosis, Stable Coronary Disease

Intervention / Treatment
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* Procedure: TAVI procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 years Severe and symptomatic aortic stenosis defined as a median trans-valvular gradient higher than 40 mmHg and an aortic valve area of less than 1.0 cm2 or 0,6 cm2/m2 on echocardiography associated to significant CAD defined by ≥1 stenosis of ≥70% in a major epicardial coronary artery or ≥50% for left main Patients is not candidate for surgical aortic valve replacement after the multidisciplinary heart team decision. Exclusion Criteria: Recent acute coronary syndrome (within 30 days before randomization), Unprotected left main disease Critical stenosis (>90%) of Left Anterior Descending artery (LAD), Significant angina (CCS class more than 2) Active bleeding, Contraindication for tomographic technetium-99 assessment or dipyridamole injection Previous enrollment in a other study Impossibly to obtain consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional Arm<br> | Procedure: TAVI procedure<br>* Targeted and selected revascularization guided on myocardial ischemia detection after the TAVI procedure by using single photon emission computed tomography (SPECT) myocardial perfusion imaging.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is a composite of all cause of death | Mortality is defined as death due to any cause, the exact nature and date of which will be recorded. All deaths will be considered cardiovascular-related unless there is documentation to the contrary. | 6 months | 
| The primary endpoint is a composite of stroke |  | 6 months | 
| The primary endpoint is a composite of major bleeding | Major bleedings are defined by ≥2 BARC classification. | 6 months | 
| The primary endpoint is a composite of major vascular complication | Access site complications is defined in accordance with the Valve Academic Research Consortium (VARC) guidelines. | 6 months | 
| The primary endpoint is a composite of periprocedural myocardial infarction | Perprocedural myocardial infarction is defined by 5-fold increased of basal troponin level associated to angina or ECG changes | 6 months | 
| The primary endpoint is a composite of hospitalization for cardiac cause. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-TAVI mortality |  | 1 and 6 months | 
| Major adverse cardiovascular or cerebrovascular event (MACCE) |  | 1 and 6 months | 
| Acute coronary syndrome (ACS) |  | 1 and 6 months | 
| Acute myocardial infarction (MI) |  | 1 and 6 months | 
| Rate of stroke |  | 1 and 6 months | 
| Repeat revascularization by either PCI or CABG |  | 1 and 6 months | 
| Hospitalization for heart failure or for non cardiovascular causes |  | 1 and 6 months | 
| Duration of hospital stay |  | 1 and 6 months | 
| Quality of life by Kansas city cardiomyopathy questionnaire |  | 1 and 6 months | 
| Per-procedural complications | ventricular fibrillation (VF), ventricular tachycardia (VT) requiring cardioversion, cardiopulmonary arrest requiring cardiopulmonary resuscitation (CPR) and/or assisted mechanical respiratory support | 1 and 6 months | 
| percentage of pacemaker after implantation of the valve |  | 1 and 6 months | 
| Bleeding complications according to the BARC classification |  | 1 and 6 months | 
| Severe VARC Access Site Complications (Safety Issue at 1 and 6 months) |  | 1 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAVI, Aortic stenosis, Coronary artery disease, Coronary angiography, Percutaneous Coronary Intervention, Myocardial ischemia, SPECT, Coronary revascularization