Clinical trial NCT02797158: Post TAVI Coronary REVASCularisation Guided by Myocardial Perfusion Imaging: a Prospective Open Label Pilot Study: The REVASC-TAVI Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe and Symptomatic Aortic Stenosis
Stable Coronary Disease
Keywords: TAVI
Aortic stenosis
Coronary artery disease
Coronary angiography
Percutaneous Coronary Intervention
Myocardial ischemia
SPECT
Coronary revascularization
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-06-13
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The primary endpoint is a composite of all cause of death
timeFrame: 6 months
measure: The primary endpoint is a composite of stroke
timeFrame: 6 months
measure: The primary endpoint is a composite of major bleeding
timeFrame: 6 months
measure: The primary endpoint is a composite of major vascular complication
timeFrame: 6 months
measure: The primary endpoint is a composite of periprocedural myocardial infarction
timeFrame: 6 months
measure: The primary endpoint is a composite of hospitalization for cardiac cause.
timeFrame: 6 months
Secondary outcomes:
measure: Post-TAVI mortality
timeFrame: 1 and 6 months
measure: Major adverse cardiovascular or cerebrovascular event (MACCE)
timeFrame: 1 and 6 months
measure: Acute coronary syndrome (ACS)
timeFrame: 1 and 6 months
measure: Acute myocardial infarction (MI)
timeFrame: 1 and 6 months
measure: Rate of stroke
timeFrame: 1 and 6 months
measure: Repeat revascularization by either PCI or CABG
timeFrame: 1 and 6 months
measure: Hospitalization for heart failure or for non cardiovascular causes
timeFrame: 1 and 6 months
measure: Duration of hospital stay
timeFrame: 1 and 6 months
measure: Quality of life by Kansas city cardiomyopathy questionnaire
timeFrame: 1 and 6 months
measure: Per-procedural complications
timeFrame: 1 and 6 months
measure: percentage of pacemaker after implantation of the valve
timeFrame: 1 and 6 months
measure: Bleeding complications according to the BARC classification
timeFrame: 1 and 6 months
measure: Severe VARC Access Site Complications (Safety Issue at 1 and 6 months)
timeFrame: 1 and 6 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier University Hospital
Study officials:
affiliation: Montpellier University Hospital
name: Florence LECLERCQ, PU PH
role: PRINCIPAL_INVESTIGATOR
References: