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

University Hospital, Montpellier71 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Severe and Symptomatic Aortic Stenosis Stable Coronary Disease

Interventions

TAVI procedurePROCEDURE

Targeted and selected revascularization guided on myocardial ischemia detection after the TAVI procedure by using single photon emission computed tomography (SPECT) myocardial perfusion imaging.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Montpellier University Hospital

Montpellier, France

Outcomes

Primary Outcomes

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.

Time frame: 6 months

The primary endpoint is a composite of stroke

Time frame: 6 months

The primary endpoint is a composite of major bleeding

Major bleedings are defined by ≥2 BARC classification.

Time frame: 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.

Time frame: 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

Time frame: 6 months

The primary endpoint is a composite of hospitalization for cardiac cause.

Time frame: 6 months

Secondary Outcomes

Post-TAVI mortality

Time frame: 1 and 6 months

Major adverse cardiovascular or cerebrovascular event (MACCE)

Time frame: 1 and 6 months

Acute coronary syndrome (ACS)

Data from ClinicalTrials.gov

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