| Randomized evaluation of the TriActiv balloon-protection flush and extraction system for the treatment of saphenous vein graft disease. | |
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MedLine Citation:
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PMID: 16256868 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVES: The Protection During Saphenous Vein Graft Intervention to Prevent Distal Embolization (PRIDE) study compared outcomes with the TriActiv System (Kensey Nash Corp., Exton, Pennsylvania), a balloon-protection flush and extraction device, with an embolic protection group during treatment of saphenous venous grafts (SVGs). BACKGROUND: Treatment of SVGs with embolic protection reduces adverse cardiac events. METHODS: We conducted a prospective trial randomizing 631 patients with coronary ischemia and lesions in SVGs to embolic protection with the TriActiv System or control group (Guardwire System [Medtronic AVE, Santa Rosa, California] or Filterwire EX [Boston Scientific Corp., Maple Grove, Minnesota]). RESULTS: The incidence of major adverse cardiac events at 30 days was 11.2% for the TriActiv group and 10.1% for the control group (relative risk = 1.1%; 95% confidence interval 0.67 to 1.76; p = 0.65; p = 0.02 for non-inferiority). Safety and efficacy end points were similar between groups except that patients randomized to the TriActiv System had more hemorrhagic complications (10.9% vs. 5.4%; p = 0.01). CONCLUSIONS: The TriActiv System was not inferior to approved embolic protection devices for the treatment of diseased SVGs. |
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Authors:
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Joseph P Carrozza; Michael Mumma; Jeffrey A Breall; Aland Fernandez; Eugene Heyman; Christopher Metzger; |
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Publication Detail:
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Type: Journal Article; Randomized Controlled Trial Date: 2005-10-10 |
Journal Detail:
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Title: Journal of the American College of Cardiology Volume: 46 ISSN: 1558-3597 ISO Abbreviation: J. Am. Coll. Cardiol. Publication Date: 2005 Nov |
Date Detail:
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Created Date: 2005-10-31 Completed Date: 2005-12-29 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8301365 Medline TA: J Am Coll Cardiol Country: United States |
Other Details:
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Languages: eng Pagination: 1677-83 Citation Subset: AIM; IM |
Affiliation:
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Section of Interventional Cardiology-Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, USA. jcarrozz@bidmc.harvard.edu |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Aged, 80 and over Balloon Occlusion / instrumentation* Female Graft Occlusion, Vascular / therapy* Humans Male Middle Aged Postoperative Complications / therapy* Prospective Studies Saphenous Vein / transplantation* |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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