Randomized Trial Evaluating Percutaneous Coronary Intervention for the Treatment of Chronic Total Occlusion: The DECISION-CTO Trial

Background: Procedural results for percutaneous coronary intervention (PCI) in coronary vessels with chronic total occlusion (CTO) have improved in recent years, and PCI strategies have moved toward more complete revascularization with more liberal use of CTO-PCI. However, evidence evaluating CTO-PCI is limited to observational studies and small clinical trials. Methods: In this open-label, multicenter, randomized, noninferiority trial, PCI-eligible patients were assigned to receive either one of two strategies; PCI or no PCI for the qualifying de novo CTO lesion with the option for PCI of obstructive non-CTO lesions at the discretion of the operator. The primary endpoint was a composite of death, myocardial infarction, stroke, or any revascularization. Health-related quality of life was assessed at baseline and at 1, 6, 12, 24, and 36 months. Because of slow recruitment, the trial was stopped before completion of the 1,284 planned enrollments. Results: Between March 2010 and September 2016, 834 patients ...