Document Detail


Safety and feasibility of orbital atherectomy for the treatment of calcified coronary lesions: the ORBIT I trial.
MedLine Citation:
PMID:  23460596     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: The ORBIT I trial evaluated the safety and performance of an orbital atherectomy system (OAS) for the treatment of de novo calcified coronary lesions.
BACKGROUND: Severely calcified coronary arteries pose an ongoing treatment challenge. Stent placement in calcified lesions can result in stent under expansion, malapposition, and procedural complications. OAS treatment may change calcified lesion compliance to reduce procedural complications and facilitate stent placement.
METHODS: The ORBIT I trial, a prospective, nonrandomized study, was conducted in two centers in India. Fifty patients with de novo calcified coronary lesions were enrolled. Patients were treated with the OAS followed by stent placement.
RESULTS: The average age of the patients was 57.4 years and 90% were male. Mean lesion length was 13.4 mm. The average number of OAS devices used per patient was 1.3. Device success was 98%, and procedural success was 94%. The cumulative major adverse cardiac event rate was 4% in-hospital (two non-Q-wave myocardial infarctions), 6% at 30 days (one additional non-Q-wave myocardial infarction leading to target lesion revascularization), and 8% at 6 months (one additional event of cardiac death). Angiographic complications were observed in seven patients (six dissections and one perforation).
CONCLUSION: The ORBIT I trial suggests that the OAS may offer an effective method to change compliance of calcified coronary lesions to facilitate optimal stent placement in these difficult to treat patients. A larger trial is required to establish safety and overall effectiveness of the OAS in treating calcified coronary lesions.
Authors:
Keyur Parikh; Praveen Chandra; Nishit Choksi; Puneet Khanna; Jeffrey Chambers
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study     Date:  2013-03-05
Journal Detail:
Title:  Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions     Volume:  81     ISSN:  1522-726X     ISO Abbreviation:  Catheter Cardiovasc Interv     Publication Date:  2013 Jun 
Date Detail:
Created Date:  2013-05-24     Completed Date:  2013-12-27     Revised Date:  2014-07-31    
Medline Journal Info:
Nlm Unique ID:  100884139     Medline TA:  Catheter Cardiovasc Interv     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1134-9     Citation Subset:  IM    
Copyright Information:
Copyright © 2012 Wiley Periodicals, Inc.
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MeSH Terms
Descriptor/Qualifier:
Atherectomy, Coronary* / adverse effects,  instrumentation,  mortality
Coronary Angiography
Coronary Artery Disease / diagnosis,  mortality,  therapy*
Equipment Design
Feasibility Studies
Female
Humans
India
Male
Middle Aged
Myocardial Infarction / etiology,  mortality
Percutaneous Coronary Intervention* / adverse effects,  instrumentation,  mortality
Prospective Studies
Stents
Time Factors
Treatment Outcome
Vascular Calcification / diagnosis,  mortality,  therapy*
Comments/Corrections
Comment In:
Catheter Cardiovasc Interv. 2013 Jun 1;81(7):1140-1   [PMID:  23704066 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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