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: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clinical Centre of Serbia

Criteria

Inclusion Criteria:

• CTO of coronary artery (TIMI 0 flow)

• a) Stabile angina and/or b) evidence of ischemia in the territory of the CTO and/or c) evidence of viable myocardium in the CTO territory

• target coronary artery with a reference diameter of 2.5 mm

Exclusion Criteria:

• acute myocardial infarction in past month

• contraindications for dual antiplatelet therapy in future 12 months

• contraindications for drug eluting stents (DES)

• informed consent not signed

• CTO in bypass graft

• EF <20 %

• Dementia

• Patient not available for follow-up

• CVI or TIA in past 6 months

• Patients with:

1. neutropenia (<1000 /mm3) in past two weeks

2. thrombocytopenia (<100 000/mm3)

3. AST, ALT, alkaline phosphatase >1.5x the upper limit of normal

4. serum creatine >2 mg/dL (>180 µmol/L)

• Patients with allergy to iodine contrast that cannot be treated medically

• Life expectancy not longer than one year

• Patients with bleeding diathesis or coagulopathy or will refuse transfusions.