| Trials of endovascular treatment for superficial femoral artery occlusive lesions: a call for medically managed control patients. | |
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MedLine Citation:
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PMID:Â 20036508 Â Â Â Owner:Â NLM Â Â Â Status:Â MEDLINE Â Â Â |
Abstract/OtherAbstract:
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BACKGROUND: The prevalence of occlusive peripheral vascular disease in the superficial femoral artery approaches 20% in patients over the age of 60. Symptomatic peripheral arterial disease (intermittent claudication) is present in 3% to 7% of patients over the age of 60. The attraction of minimally invasive, percutaneous endovascular angioplasty (PTA) for this large number of patients has resulted in multiple trials of new PTA +/- stenting devices. The purpose of this report is to determine whether trials should include controlled patients who have optimal medical management including supervised exercise. METHODS AND RESULTS: In 2007 through 2008, there were 12 active trials of PTA and stent with 9 of the trials randomized and 6 trials using PTA as the control arm. No trial used a medically managed group. Between 1990 and 2008, a search of PubMed disclosed six publications (five randomized trials) comparing PTA +/- stent with medically (exercise) managed claudicants. None of the medically managed patient groups experienced a significant increase in ABI, whereas endovascular patients had an early increase in ABI, which was variably sustained to 1 and 2 years. However, after 6 months, the maximum walking distance was significantly increased in the exercised patients and remained longer than that of the interventional group in four of five trials at 1 to 2 years. CONCLUSION: Endovascular treatment was superior to medical treatment in functional outcome at 1 year in only one of the five randomized trials for claudication. In the other four trials, medical treatment produced a greater maximum walking distance at 1 to 2 years. Current trials lack optimal medical controls. New trials of PTA + stent should include a medically managed group of patients in a supervised exercise program as the comparator arm. The outcome measure should be maximum walking distance to demonstrate added functional benefit of the new device. |
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Authors:
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Samuel E Wilson |
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Publication Detail:
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Type: Journal Article; Review    Date: 2009-12-29 |
Journal Detail:
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Title: Annals of vascular surgery    Volume: 24    ISSN: 1615-5947    ISO Abbreviation: Ann Vasc Surg    Publication Date: 2010 May |
Date Detail:
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Created Date:Â 2010-05-10 Â Â Â Completed Date:Â 2010-08-12 Â Â Â Revised Date:Â - Â Â Â |
Medline Journal Info:
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Nlm Unique ID: 8703941    Medline TA: Ann Vasc Surg    Country: United States    |
Other Details:
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Languages: eng    Pagination: 498-502    Citation Subset: IM    |
Copyright Information:
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Copyright 2010 Annals of Vascular Surgery Inc. Published by Elsevier Inc. All rights reserved. |
Affiliation:
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Department of Surgery, University of California, Irvine, CA, and Surgical Service, VA Medical Center, Long Beach, CA 92868, USA. WilsonSE@UCI.EDU |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Aged Angioplasty, Balloon* / instrumentation Ankle Brachial Index Arterial Occlusive Diseases / complications, physiopathology, therapy* Constriction, Pathologic Controlled Clinical Trials as Topic / methods* Endpoint Determination Evidence-Based Medicine Exercise Therapy* Female Femoral Artery* Humans Intermittent Claudication / etiology, therapy Male Middle Aged Randomized Controlled Trials as Topic / methods* Recovery of Function Research Design* Stents Time Factors Treatment Outcome Walking |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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