Document Detail


Randomized comparison of everolimus-eluting versus bare-metal stents in patients with critical limb ischemia and infrapopliteal arterial occlusive disease.
MedLine Citation:
PMID:  22169682     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: Critical limb ischemia, the most severe form of peripheral arterial disease, results in extremity amputation if left untreated. Endovascular recanalization of stenotic or occluded infrapopliteal arteries has recently emerged as an effective form of therapy, although the duration of patency is typically limited by restenosis. Recently, it has been suggested that drug-eluting stents originally developed for the coronary arteries might also be effective in preventing restenosis in the infrapopliteal arteries. This prospective, randomized, controlled clinical trial tested the hypothesis that treatment of infrapopliteal arterial occlusive lesions with an everolimus-eluting stent (Xience V) would provide superior patency to treatment with a bare-metal stent (Multi-Link Vision).
METHODS: A sample size of 140 patients was planned to be enrolled at five European investigative sites. The primary end point was arterial patency at 12 months, defined as the absence of ≥50% restenosis based on quantitative analysis of contrast angiography.
RESULTS: Between March of 2008 and September of 2009, 74 patients were treated with Xience V and 66 patients were treated with Vision. After 12 months, the primary patency rate after treatment with Xience V was 85% compared with 54% after treatment with Vision (P = .0001). Treatment with Xience V significantly reduced mean in-stent diameter stenosis (21% ± 21% vs 47% ± 27%; P < .0001) and mean in-stent late lumen loss (0.78 ± 0.63 vs 1.41 ± 0.89 mm; P = .001). There were no differences in the percentage of patients receiving a designation of Rutherford class 0 or 1 at the 12-month follow-up visit (56% for Vision, vs 60% for Xience V; P = .68). Major extremity amputations were rare in both groups (two for Vision and one for Xience V). The use of the Xience V stent significantly reduced the need for repeat intervention: freedom from target lesion revascularization was 91% for Xience V vs 66% for Vision (P = .001).
CONCLUSIONS: Treatment of the infrapopliteal occlusive lesions of critical limb ischemia with everolimus-eluting stents reduces restenosis and the need for reintervention compared with bare metal stents.
Authors:
Marc Bosiers; Dierk Scheinert; Patrick Peeters; Giovanni Torsello; Thomas Zeller; Koen Deloose; Andrej Schmidt; Jörg Tessarek; Erwin Vinck; Lewis B Schwartz
Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2011-12-14
Journal Detail:
Title:  Journal of vascular surgery     Volume:  55     ISSN:  1097-6809     ISO Abbreviation:  J. Vasc. Surg.     Publication Date:  2012 Feb 
Date Detail:
Created Date:  2012-01-23     Completed Date:  2012-03-12     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:  390-8     Citation Subset:  IM    
Copyright Information:
Copyright © 2012 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.
Affiliation:
Department of Vascular Surgery, AZ Sint-Blasius, Dendermonde, Belgium. marc.bosiers@telenet.be
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00510393
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MeSH Terms
Descriptor/Qualifier:
Aged
Aged, 80 and over
Amputation
Angioplasty / adverse effects,  instrumentation*
Arterial Occlusive Diseases / complications,  physiopathology,  radiography,  therapy*
Cardiovascular Agents / administration & dosage*
Constriction, Pathologic
Critical Illness
Drug-Eluting Stents*
Europe
Female
Humans
Ischemia / etiology,  physiopathology,  radiography,  therapy*
Kaplan-Meier Estimate
Limb Salvage
Male
Metals*
Middle Aged
Popliteal Artery* / physiopathology,  radiography
Prospective Studies
Prosthesis Design
Recurrence
Risk Assessment
Risk Factors
Sirolimus / administration & dosage,  analogs & derivatives*
Stents*
Time Factors
Treatment Outcome
Vascular Patency
Chemical
Reg. No./Substance:
0/Cardiovascular Agents; 0/Metals; 159351-69-6/everolimus; 53123-88-9/Sirolimus
Comments/Corrections
Comment In:
J Vasc Surg. 2012 Feb;55(2):398-9   [PMID:  22264803 ]

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


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