S Jens1, A P Conijn2, M J W Koelemay2, S Bipat3, J A Reekers3. 1. Department of Radiology, Academic Medical Center, Amsterdam, The Netherlands. Electronic address: s.jens@amc.uva.nl. 2. Department of Surgery, Academic Medical Center, Amsterdam, The Netherlands. 3. Department of Radiology, Academic Medical Center, Amsterdam, The Netherlands.
Abstract
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<.0001) in diabetic patients after 12 months. Amputation and death rate did not differ significantly. For DES versus BS, most trials showed equal efficacy between strategies. CONCLUSION: Based on low- to moderate-quality evidence, PTA with optional bailout stenting using BS should remain the preferred strategy in treating CLI patients with BTK arterial lesions. Before other strategies can be implemented, larger and high-quality RCTs assessing clinically relevant outcomes are needed.
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<.0001) in diabeticpatients after 12 months. Amputation and death rate did not differ significantly. For DES versus BS, most trials showed equal efficacy between strategies. CONCLUSION: Based on low- to moderate-quality evidence, PTA with optional bailout stenting using BS should remain the preferred strategy in treating CLI patients with BTK arterial lesions. Before other strategies can be implemented, larger and high-quality RCTs assessing clinically relevant outcomes are needed.
Authors: Marlon I Spreen; Jasper M Martens; Bob Knippenberg; Lukas C van Dijk; Jean-Paul P M de Vries; Jan Albert Vos; Gert Jan de Borst; Evert-Jan P A Vonken; Okker D Bijlstra; Jan J Wever; Randolph G Statius van Eps; Willem P Th M Mali; Hendrik van Overhagen Journal: J Am Heart Assoc Date: 2017-04-14 Impact factor: 5.501
Authors: G K Ambler; A L Stimpson; B G Wardle; D C Bosanquet; U K Hanif; S Germain; C Chick; N Goyal; C P Twine Journal: PLoS One Date: 2017-02-15 Impact factor: 3.240