REvascularization Versus Optimal Medical Therapy on Left Ventricular ISchemia Reduction: Exploring the Associations Between Ischemia, Functional Outcome and Collaterals in the Treatment of Chronic Total Occlusion Patients
Objective: Primary objective is to determine whether PCI of the CTO will yield a higher reduction of ischemia assessed by exercise myocardial perfusion SPECT-CT from baseline to 6-month follow-up compared to a control group. Secondary objectives are 1) to evaluate the effect of PCI of the CTO on improvement in functional status, infarct size and left ventricular function from baseline to follow-up compared to the control group; 2) to study the association between ischemia reduction and functional outcome and left ventricular function; 3) to assess the influence of the collateral flow index on the ischemic burden (reduction), functional status, infarct size and left ventricular (contractile) function (hibernation). Study design: open multicentre randomized trial Study population: 82 patients eligible for CTO PCI Intervention: CTO PCI Primary endpoint: ischemic burden assessed with exercise myocardial perfusion SPECT-CT from baseline to 6 months follow-up.
• A chronic total occlusion is present and target lesion. A CTO is required to meet the following characteristics:
‣ A 100% luminal narrowing of the coronary artery without antegrade flow, i.e. Thrombolysis in Myocardial Infarction flow grade 0 or 1;
⁃ Older than 3 months, established with previous PCI or with angiographic characteristics;
⁃ Amenable to percutaneous revascularization.
• Patient has a clinical indication to perform CTO PCI.
• A SPECT is performed at baseline to assess ischemia and a cardiac magnetic resonance imaging (CMR) scan to assess viability, as part of routine patient care. Patients are deemed eligible for the randomized trial when they meet the ischemic threshold in the CTO territory.
• The ischemic threshold is defined as:
⁃ \>12.5% of ischemia;
⁃ With \<50% transmural extent of infarction.
• Subject agrees to undergo follow-up SPECT-CT at 6 months after initial inclusion
• Subject is able to verbally confirm understanding and he/she provides written informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee.