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