Key result
CTO-PCI registry enrollment shows no difference in procedural success or MACE versus nonenrollment.
Why the study?
There is a compelling need to better quantify the safety, efficacy, benefits, and costs of chronic total occlusion-percutaneous coronary intervention in patients with complex coronary lesions.
Observational (n=1,000)
Yes
The OPEN CTO registry successfully enrolled 1000 patients to evaluate the safety, efficacy, and costs of CTO-PCI, with an audited enrollment process showing similar procedural outcomes between enrolled and non-enrolled eligible patients.
Supports health status gains after successful hybrid CTO PCI in experienced centers; leaves open whether benefits exceed risks or medical therapy in broader populations.
BACKGROUND: Patients with chronic total occlusions of a coronary artery represent a complex, yet common, clinical conundrum among patients with ischemic heart disease. Chronic total occlusion angioplasty is increasingly being used as a treatment for these complex lesions. There is a compelling need to better quantify the safety, efficacy, benefits, and costs of the procedure. METHODS: To address these gaps in knowledge, we designed the Outcomes, Patient Health Status, and Efficiency IN Chronic Total Occlusion Hybrid Procedures (OPEN CTO) study, an investigator-initiated multicenter, single-arm registry including 12 centers with a planned enrollment of 1000 patients. To ensure the accuracy of our observations, we used a unique auditing process through the National Cardiovascular Disease Registries' Cath/PCI Registry, angiographic core lab analysis, clinical events adjudication, and a systematic collection of patient-reported outcomes and costs. RESULTS: Between 21 January 2014 and 22 July 2015, 1000 patients were enrolled in OPEN CTO. A total of 28 patients either refused (N=26) or were missed by the screening process (N=2). In the National Cardiovascular Disease Registry Cath/PCI registry audit, there were 1096 chronic total occlusion-percutaneous coronary intervention procedures that were performed by participating operators during the time they enrolled in OPEN CTO. Overall, 987 of those patients could be definitively matched to an OPEN CTO enrolled patient (enrolled group). The remaining 109 were considered to be not enrolled in OPEN CTO (not enrolled group). Compared with the enrolled group, the patients in the nonenrolled group were less frequently of White race and more frequently of Hispanic origin. Procedural outcomes including National Cardiovascular Disease Registry-defined technical success, procedural success, and major adverse coronary events rates were similar. CONCLUSION: OPEN CTO is the most comprehensive and rigorously collected dataset to date that will provide unique insights into the success, safety, benefits, and the costs of chronic total occlusion-percutaneous coronary intervention using a reproducible technical approach to patients with these complex lesions.
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Sapontis et al. (2016) conducted an observational in Chronic total occlusions of a coronary artery (n=1,000). Chronic total occlusion-percutaneous coronary intervention vs. Nonenrolled patients was evaluated on Procedural outcomes including technical success, procedural success, and major adverse coronary events. In a multicenter registry of 1,000 patients undergoing chronic total occlusion PCI, procedural success and major adverse coronary event rates were similar between enrolled and nonenrolled patients.
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