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

Stable Coronary Disease Clinical Trial

— REVASC-TAVI  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02797158
• Other study ID #: 9674
• Status: Completed
• Phase: N/A
• Start date: June 23, 2016
• Est. completion date: July 15, 2019

Study information

• Verified date: May 2019
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: July 15, 2019
• Est. primary completion date: July 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Coronary Artery Disease
• Coronary Disease
• Severe and Symptomatic Aortic Stenosis
• Stable Coronary Disease

Intervention

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.

Locations

Country	Name	City	State
France	Montpellier University Hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	The primary endpoint is a composite of stroke		6 months
Primary	The primary endpoint is a composite of major bleeding	Major bleedings are defined by =2 BARC classification.	6 months
Primary	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
Primary	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
Primary	The primary endpoint is a composite of hospitalization for cardiac cause.		6 months
Secondary	Post-TAVI mortality		1 and 6 months
Secondary	Major adverse cardiovascular or cerebrovascular event (MACCE)		1 and 6 months
Secondary	Acute coronary syndrome (ACS)		1 and 6 months
Secondary	Acute myocardial infarction (MI)		1 and 6 months
Secondary	Rate of stroke		1 and 6 months
Secondary	Repeat revascularization by either PCI or CABG		1 and 6 months
Secondary	Hospitalization for heart failure or for non cardiovascular causes		1 and 6 months
Secondary	Duration of hospital stay		1 and 6 months
Secondary	Quality of life by Kansas city cardiomyopathy questionnaire		1 and 6 months
Secondary	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
Secondary	percentage of pacemaker after implantation of the valve		1 and 6 months
Secondary	Bleeding complications according to the BARC classification		1 and 6 months
Secondary	Severe VARC Access Site Complications (Safety Issue at 1 and 6 months)		1 and 6 months