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

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.

Study Overview

• Status: Completed
• Conditions: Stable Coronary Disease; Severe and Symptomatic Aortic Stenosis
• Intervention / Treatment: Procedure: TAVI procedure

Detailed Description

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
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Montpellier University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Interventional Arm	Procedure: TAVI procedure; Targeted and selected revascularization guided on myocardial ischemia detection after the TAVI procedure by using single photon emission computed tomography (SPECT) myocardial perfusion imaging.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Florence LECLERCQ, PU PH, Montpellier University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 23, 2016
• Primary Completion (ACTUAL): July 15, 2019
• Study Completion (ACTUAL): July 15, 2019

Study Registration Dates

• First Submitted: May 30, 2016
• First Submitted That Met QC Criteria: June 7, 2016
• First Posted (ESTIMATE): June 13, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 24, 2019
• Last Update Submitted That Met QC Criteria: July 23, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Coronary angiography; Coronary artery disease; Percutaneous Coronary Intervention; SPECT; TAVI; Aortic stenosis; Myocardial ischemia; Coronary revascularization
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Coronary Disease; Aortic Valve Stenosis
• Other Study ID Numbers: 9674