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The Outcomes, Patient Health Status, and Efficiency IN Chronic Total Occlusion Hybrid Procedures registry: rationale and design

Sapontis, James; Marso, Steven P.; Cohen, David J.; Lombardi, William; Karmpaliotis, Dimitri; Moses, Jeffrey; Nicholson, William J.; Pershad, Ashish; Wyman, R. Michael; Spaedy, Anthony; Cook, Stephen; Doshi, Parag; Federici, Robert; Thompson, Craig R.; Nugent, Karen; Gosch, Kensey; Spertus, John A.; Grantham, J. Aaronon behalf of the OPEN CTO Study Group

doi: 10.1097/MCA.0000000000000439
Original Research
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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.

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

Correspondence to J. Aaron Grantham, MD, FACC, Saint Luke’s Mid America Heart Institute, 4401 Wornall Rd, NSI 5th floor, Kansas City, MO 64111, USA Tel: +1 816 932 5475; fax: +1 816 932 5798; e-mail: jgrantham@saint-lukes.org

Received July 24, 2016

Received in revised form August 27, 2016

Accepted September 13, 2016

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