Study Comparing PCI Using Latest Drug-Eluting Stents Versus Optimal Medical Therapy for Chronic Total Coronary Occlusions with Myocardial Ischemia

What this Trial Is About

This research aims to evaluate the outcomes of treating chronic total occlusion CTO in coronary arteries, a condition linked to worse heart health compared to other coronary artery diseases. The study investigates whether using the latest drug-eluting stents in a procedure called Percutaneous Coronary Intervention PCI is better than optimal medical therapy OMT alone. It focuses on two groups asymptomatic patients with significant myocardial ischemia and symptomatic patients with moderate ischemia, to understand effects on major cardiovascular events and quality of life. All participants will begin with three months of optimal medical therapy. After this, they will be assigned to one of two groups based on symptoms and ischemia level Cohort A includes asymptomatic patients with at least 10% ischemia, randomized to PCI or continued OMT Cohort B includes symptomatic patients with at least 5% ischemia, also randomized to PCI or OMT, with the option for PCI after six months if symptoms persist. An additional Cohort C includes patients who do not meet criteria for randomization but will be followed in a registry. Participants will undergo regular follow-ups for up to five years in Cohort A and six months in Cohort B. Researchers will assess major adverse cardiovascular and cerebrovascular events MACCE and quality of life using the Seattle Angina Questionnaire. Before randomization, patients will be monitored for symptom class and ischemia levels using nuclear imaging. Safety and health status will be tracked through clinical visits, with the study aiming to provide clearer evidence on CTO treatment benefits and risks over time.

ISCHEMIA-CTO Trial - Revascularisation or Optimal Medical Therapy of CTO