title: The Outcomes, Patient Health Status, and Efficiency IN Chronic Total Occlusion Hybrid Procedures registry: rationale and design.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: aMonashHeart, Melbourne, Victoria, Australia bResearch Medical Center cSaint Luke's Mid America Heart Institute dDepartment of Medicine, University of Missouri - Kansas City, Kansas City eBoone County Hospital, Columbia, Missouri fDepartment of Medicine, University of Washington, Seattle, Washington gDepartment of Medicine, Columbia University, New York Presbyterian Hospital, New York, New York hWellSpan York Hospital, York, Pennsylvania iDepartment of Medicine, Banner Good Samaritan Medical Center, Phoenix jBanner Heart Hospital, Mesa, Arizona kTorrance Medical Center, Torrance, California lPeacehealth Sacred Heart Medical Center, Springfield, Oregon mAlexian Brothers Medical Center, Chicago, Illinois nPresbyterian Heart Center, Albuquerque, New Mexico oBoston Scientific Inc., Maple Grove, Minnesota, USA.
authors.forename: James
authors.initials: J
authors.lastname: Sapontis
authors.forename: Steven P
authors.initials: SP
authors.lastname: Marso
authors.forename: David J
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authors.lastname: Cohen
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authors.lastname: Lombardi
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authors.lastname: Karmpaliotis
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authors.forename: Ashish
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authors.lastname: Wyman
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authors.forename: Parag
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authors.lastname: Doshi
authors.forename: Robert
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authors.lastname: Federici
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mesh_terms: D000368:Aged; D002908:Chronic Disease; D054059:Coronary Occlusion / Q000175:diagnosis / Q000191:economics / Q000401:mortality / Q000628:therapy*; D003362:Cost-Benefit Analysis; D005260:Female; D017048:Health Care Costs; D006304:Health Status; D006801:Humans; D008297:Male; D008875:Middle Aged; D000071066:Patient Reported Outcome Measures; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000191:economics / Q000401:mortality; D017064:Process Assessment, Health Care / Q000191:economics; D012042:Registries; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology