Randomized Comparison of Optimal Medical Therapy and Percutaneous Recanalization for Chronic Total Occlusion (COMET-CTO)
Status:
Completed
Trial end date:
2017-12-31
Target enrollment:
Participant gender:
Summary
Several meta analysis comparing successful Percutaneous Coronary Intervention of Chronic
Total Occlusion (PCI-CTO) with unsuccessful PCI-CTO showed that there is significant
reduction in short-term and long-term mortality. To our knowledge till today no prospective
randomized trial compared percutaneous revascularization of CTO with optimal medical therapy.
For this reason quality of live improvement is one of the most important indications for
revascularization in elective patients with CTO. In contemporary literature Seattle Angina
Questionnaire (SAQ) is a psychometrically solid disease-specific instrument designed to
assess the functional status of patients with angina. It comprises 19 questions that quantify
five clinically relevant domains: physical limitation, angina stability, angina frequency,
treatment satisfaction and disease perception/quality of life.
In this open prospective study patients with CTO of coronary artery will be randomized in two
groups: first - patients with percutaneous coronary intervention of chronic total occlusion
with optimal medical therapy and second group - patients with only optimal medical therapy
(control group). Primary endpoint will be quality of life and secondary endpoints will be
mayor adverse cardiovascular events (MACE). All patients will complete Seattle Angina
Questionnaire before randomization and after 6 months of follow-up.