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Randomized Trials for Endovascular Treatment of Infrainguinal Arterial Disease: Systematic Review and Meta-analysis (Part 2: Below the Knee)

Objective To evaluate 1 to 48 month follow-up outcomes of different endovascular treatment strategies in below-the-knee (BTK) arterial segments in critical limb ischemia (CLI) patients. Methods Medline and Embase were searched (last searched on 5 November 2013) for studies of randomized controlled t...

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Published in:European journal of vascular and endovascular surgery 2014-05, Vol.47 (5), p.536-544
Main Authors: Jens, S, Conijn, A.P, Koelemay, M.J.W, Bipat, S, Reekers, J.A
Format: Article
Language:English
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Summary:Objective To evaluate 1 to 48 month follow-up outcomes of different endovascular treatment strategies in below-the-knee (BTK) arterial segments in critical limb ischemia (CLI) patients. Methods Medline and Embase were searched (last searched on 5 November 2013) for studies of randomized controlled trials comparing either balloon angioplasty (PTA) or drug-eluting balloon (DEB) with optional bailout stenting, or primary stenting using a bare stent (BS) or drug-eluting stent (DES) to one another. Methodological quality of each trial was assessed using a Cochrane Collaboration's tool, and quality of evidence was assessed using the GRADE system. Outcomes assessed were wound healing, quality of life, change in Rutherford classification, amputation, death, target lesion revascularization (TLR), bypass, binary restenosis, late lumen loss, stenosis grade, and event-free survival with follow-up periods of at least 1 month. Results Twelve trials including 1145 patients were identified, with 90% of patients having CLI. Six BS versus PTA and two DES versus PTA trials showed low-quality evidence of equal efficacy. One trial, comparing DEB with PTA, showed moderate-quality evidence of improved wound healing (RR 1.28; 95% CI: 1.05 to 1.56; p  = .01), improvement in Rutherford classification (RR 1.32; 95% CI: 1.08 to 1.60; p  = .008), and lower TLR (RR 0.41; 95% CI 0.23 to 0.74; p  = .002) and binary restenosis (RR 0.36; 95% CI 0.24 to 0.54; p  
ISSN:1078-5884
1532-2165
DOI:10.1016/j.ejvs.2014.02.012