Stable Coronary Disease Clinical Trial
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.
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