Benefits in left ventricular ejection fraction and global longitudinal strain of percutaneous coronary intervention vs optimal medical therapy in patients with coronary total occlusions: a multi-centric, randomized, open and controlled clinical trial

Abstract

BACKGROUND Chronic total occlusions (CTO) are observed in approximatively 20% of patients with coronary artery disease undergoing coronary angiography. This fact reflects that CTO involves a significant amount of population. However, treatment of CTO lesions has been a matter of controversy and revascularization rates have historically been low. Percutaneous coronary intervention (PCI) is performed only in 15% of the patients with CTO, most of the them are treated with optimal medical therapy (OMT) alone. Despite the low rate of revascularization, there are many observational studies that have reported clinical benefits of successful CTO-PCI, but only four clinical trial are published until now. Within this four, only one has evaluated the ventricular function and did not show differences between the two groups, in addition it only evaluate patients with STEMI. Nevertheless, observational studies and the clinical practice has shown that a successful revascularization improve the left ventricular function. For that reason is still a need to carry out more randomized clinical trials. OBJECTIVES The aim of the study and primary objective is to compare the left ventricular ejection fraction (LVEF) and global longitudinal strain (GLS) values between the two arms of treatment after 4 and 12 months. One arm of treatment will be PCI plus OMT, and the other will be only OMT. Secondary objective will be to evaluate major adverse cardiovascular and cerebrovascular events (MACCE) occurrence during follow-up. METHODS It will be a phase IV, prospective, multi-centric, open-label, randomized, controlled clinical trial with parallel groups. Patients diagnosed with a CTO will be randomly assigned with a ratio 1:1 to receive strategy with OMT, or PCI in the CTO plus OMT. The population of the study will be patients with an age over 18 years old diagnosed with at least one CTO in the three principle arteries in reference hospitals of Catalonia