Document Detail


Five-year report of a multicenter controlled clinical trial of open versus endovascular treatment of abdominal aortic aneurysms.
MedLine Citation:
PMID:  17398057     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: Compare long-term results of endovascular treatment and standard open repair of abdominal aortic aneurysms in a multicenter, concurrent-controlled trial.
METHODS: 334 subjects were treated with standard open repair (control, n = 99) or the original EXCLUDER Bifurcated Endoprosthesis (test, n = 235). Five-year clinical evaluations and corelab radiographic results are analyzed.
RESULTS: Overall and aneurysm-related survival are similar. There have been ten open conversions, most frequently for enlarging sacs without endoleak. Two patients died after conversion. Including reinterventions and complications of reinterventions as adverse events, there is significant, persistent long-term reduction in major adverse events. At 5 years, corelab reported 0% limb narrowing, 0% trunk migration, 0% component (contralateral leg, aortic extender, and iliac extender) migration, 0% fracture, endoleak in 3% (2 type II/68), and aneurysm growth (>5 mm compared to baseline) in 38% (30/78) of the test group. There are no aneurysm ruptures in either test or control group.
CONCLUSIONS: After 5 years follow-up, endovascular repair is a safer and effective treatment compared with open surgical repair for abdominal aortic aneurysms. Major adverse events are less frequent with the endograft despite the need for late reinterventions. Aneurysm expansion is observed in nearly two-fifths of patients but is not associated with endoleak or aneurysm rupture. Multicenter clinical trials are evaluating a newer version of this device designed to avoid this high rate of sac expansion.
Authors:
Brian G Peterson; Jon S Matsumura; David C Brewster; Michel S Makaroun;
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't     Date:  2007-03-29
Journal Detail:
Title:  Journal of vascular surgery     Volume:  45     ISSN:  0741-5214     ISO Abbreviation:  J. Vasc. Surg.     Publication Date:  2007 May 
Date Detail:
Created Date:  2007-04-30     Completed Date:  2007-05-24     Revised Date:  2012-10-03    
Medline Journal Info:
Nlm Unique ID:  8407742     Medline TA:  J Vasc Surg     Country:  United States    
Other Details:
Languages:  eng     Pagination:  885-90     Citation Subset:  IM    
Affiliation:
Saint Louis University, St. Louis, MO, USA.
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MeSH Terms
Descriptor/Qualifier:
Aortic Aneurysm, Abdominal / mortality,  surgery*
Blood Vessel Prosthesis Implantation*
Humans
Survival Analysis
Time Factors
Treatment Outcome
Comments/Corrections
Comment In:
J Vasc Surg. 2007 Nov;46(5):1088-9; author reply 1089-90   [PMID:  17980304 ]

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


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