Document Detail


Randomized evaluation of the TriActiv balloon-protection flush and extraction system for the treatment of saphenous vein graft disease.
MedLine Citation:
PMID:  16256868     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Joseph P Carrozza; Michael Mumma; Jeffrey A Breall; Aland Fernandez; Eugene Heyman; Christopher Metzger;
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial     Date:  2005-10-10
Journal Detail:
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:
Created Date:  2005-10-31     Completed Date:  2005-12-29     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8301365     Medline TA:  J Am Coll Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1677-83     Citation Subset:  AIM; IM    
Affiliation:
Section of Interventional Cardiology-Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, USA. jcarrozz@bidmc.harvard.edu
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MeSH Terms
Descriptor/Qualifier:
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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