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Background: The optimal strategy for revascularization in infrainguinal chronic limb-threatening ischemia (CLTI) remains debatable. Comparative trials are scarce, and daily decisions are often made using anecdotal or low-quality evidence., Methods: We searched multiple databases through May 7, 2017, for prospective studies with at least 1-year follow-up that evaluated patient-relevant outcomes of infrainguinal revascularization procedures in adults with CLTI. Independent pairs of reviewers selected articles and extracted data. Random-effects meta-analysis was used to pool outcomes across studies., Results: We included 44 studies that enrolled 8602 patients. Periprocedural outcomes (mortality, amputation, major adverse cardiac events) were similar across treatment modalities. Overall, patients with infrapopliteal disease had higher patency rates of great saphenous vein graft at 1 and 2 years (primary: 87%, 78%; secondary: 94%, 87%, respectively) compared with all other interventions. Prosthetic bypass outcomes were notably inferior to vein bypass in terms of amputation and patency outcomes, especially for below knee targets at 2 years and beyond. Drug-eluting stents demonstrated improved patency over bare-metal stents in infrapopliteal arteries (primary patency: 73% vs 50% at 1 year), and was at least comparable to balloon angioplasty (66% primary patency). Survival, major amputation, and amputation-free survival at 2 years were broadly similar between endovascular interventions and vein bypass, with prosthetic bypass having higher rates of limb loss. Overall, the included studies were at moderate to high risk of bias and the quality of evidence was low., Conclusions: There are major limitations in the current state of evidence guiding treatment decisions in CLTI, particularly for severe anatomic patterns of disease treated via endovascular means. Periprocedural (30-day) mortality, amputation, and major adverse cardiac events are broadly similar across modalities. Patency rates are highest for saphenous vein bypass, whereas both patency and limb salvage are markedly inferior for prosthetic grafting to below the knee targets. Among endovascular interventions, percutaneous transluminal angioplasty and drug-eluting stents appear comparable for focal infrapopliteal disease, although no studies included long segment tibial lesions. Heterogeneity in patient risk, severity of limb threat, and anatomy treated renders direct comparison of outcomes from the current literature challenging. Future studies should incorporate both limb severity and anatomic staging to best guide clinical decision making in CLTI., (Copyright © 2019. Published by Elsevier B.V.)

Background: The optimal strategy for revascularization in infrainguinal chronic limb-threatening ischemia (CLTI) remains debatable. Comparative trials are scarce, and daily decisions are often made using anecdotal or low-quality evidence., Methods: We searched multiple databases through May 7, 2017, for prospective studies with at least 1-year follow-up that evaluated patient-relevant outcomes of infrainguinal revascularization procedures in adults with CLTI. Independent pairs of reviewers selected articles and extracted data. Random-effects meta-analysis was used to pool outcomes across studies., Results: We included 44 studies that enrolled 8602 patients. Periprocedural outcomes (mortality, amputation, major adverse cardiac events) were similar across treatment modalities. Overall, patients with infrapopliteal disease had higher patency rates of great saphenous vein graft at 1 and 2 years (primary: 87%, 78%; secondary: 94%, 87%, respectively) compared with all other interventions. Prosthetic bypass outcomes were notably inferior to vein bypass in terms of amputation and patency outcomes, especially for below knee targets at 2 years and beyond. Drug-eluting stents demonstrated improved patency over bare-metal stents in infrapopliteal arteries (primary patency: 73% vs 50% at 1 year), and was at least comparable to balloon angioplasty (66% primary patency). Survival, major amputation, and amputation-free survival at 2 years were broadly similar between endovascular interventions and vein bypass, with prosthetic bypass having higher rates of limb loss. Overall, the included studies were at moderate to high risk of bias and the quality of evidence was low., Conclusions: There are major limitations in the current state of evidence guiding treatment decisions in CLTI, particularly for severe anatomic patterns of disease treated via endovascular means. Periprocedural (30-day) mortality, amputation, and major adverse cardiac events are broadly similar across modalities. Patency rates are highest for saphenous vein bypass, whereas both patency and limb salvage are markedly inferior for prosthetic grafting to below the knee targets. Among endovascular interventions, percutaneous transluminal angioplasty and drug-eluting stents appear comparable for focal infrapopliteal disease, although no studies included long segment tibial lesions. Heterogeneity in patient risk, severity of limb threat, and anatomy treated renders direct comparison of outcomes from the current literature challenging. Future studies should incorporate both limb severity and anatomic staging to best guide clinical decision making in CLTI., (Copyright © 2019. Published by Elsevier Inc.)

Background: The optimal strategy for revascularization in infrainguinal chronic limb-threatening ischemia (CLTI) remains debatable. Comparative trials are scarce, and daily decisions are often made using anecdotal or low-quality evidence., Methods: We searched multiple databases through May 7, 2017, for prospective studies with at least 1-year follow-up that evaluated patient-relevant outcomes of infrainguinal revascularization procedures in adults with CLTI. Independent pairs of reviewers selected articles and extracted data. Random-effects meta-analysis was used to pool outcomes across studies., Results: We included 44 studies that enrolled 8602 patients. Periprocedural outcomes (mortality, amputation, major adverse cardiac events) were similar across treatment modalities. Overall, patients with infrapopliteal disease had higher patency rates of great saphenous vein graft at 1 and 2 years (primary: 87%, 78%; secondary: 94%, 87%, respectively) compared with all other interventions. Prosthetic bypass outcomes were notably inferior to vein bypass in terms of amputation and patency outcomes, especially for below knee targets at 2 years and beyond. Drug-eluting stents demonstrated improved patency over bare-metal stents in infrapopliteal arteries (primary patency: 73% vs 50% at 1 year), and was at least comparable to balloon angioplasty (66% primary patency). Survival, major amputation, and amputation-free survival at 2 years were broadly similar between endovascular interventions and vein bypass, with prosthetic bypass having higher rates of limb loss. Overall, the included studies were at moderate to high risk of bias and the quality of evidence was low., Conclusions: There are major limitations in the current state of evidence guiding treatment decisions in CLTI, particularly for severe anatomic patterns of disease treated via endovascular means. Periprocedural (30-day) mortality, amputation, and major adverse cardiac events are broadly similar across modalities. Patency rates are highest for saphenous vein bypass, whereas both patency and limb salvage are markedly inferior for prosthetic grafting to below the knee targets. Among endovascular interventions, percutaneous transluminal angioplasty and drug-eluting stents appear comparable for focal infrapopliteal disease, although no studies included long segment tibial lesions. Heterogeneity in patient risk, severity of limb threat, and anatomy treated renders direct comparison of outcomes from the current literature challenging. Future studies should incorporate both limb severity and anatomic staging to best guide clinical decision making in CLTI., (Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Critical limb ischemia is associated with a significant morbidity and mortality. We systematically reviewed the evidence to compare bypass surgery with endovascular revascularization in patients with critical limb ischemia., Methods: We systematically searched MEDLINE, Embase, Cochrane Central Register of Controlled Trials, CINAHL, and Scopus through October 2014 for comparative studies (randomized and nonrandomized). Predefined outcomes of interest were mortality, major amputation, patency, and wound healing. We pooled odds ratios (ORs) of the outcomes of interest using the random-effects model., Results: Nine studies that enrolled 3071 subjects were included. There was no significant difference in mortality (OR, 0.72; 95% confidence interval [CI], 0.44-1.16) or amputation (OR, 1.2; 95% CI, 0.87-1.65). Bypass surgery was associated with higher primary patency (OR, 2.50; 95% CI, 1.25-4.99) and assisted primary patency (OR, 3.39; 95% CI, 1.53-7.51). The quality of evidence was low for mortality and amputation outcomes and moderate for patency outcomes., Conclusions: Low quality of evidence due to imprecision and heterogeneity suggests that bypass surgery and endovascular approaches may have similar effect on mortality and major amputations. However, better primary and primary assisted patency can be expected with surgery., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Critical limb ischemia (CLI) is associated with high morbidity and mortality. Because most patients with CLI will eventually undergo some type of revascularization, the natural history of CLI is not well defined, although it is important to know when patients decide to pursue treatment., Methods: We systematically searched multiple databases for controlled and uncontrolled studies of patients with CLI who did not receive revascularization with a minimum follow-up of ≥1 year. Predefined outcomes of interest were mortality, major amputation, and wound healing. Random-effects meta-analysis was used to pool cumulative incidence across studies., Results: We identified 13 studies enrolling 1527 patients. During a median follow-up of 12 months, all-cause mortality rate was 22% (confidence interval [CI], 12%-33%) and major amputation rate was 22% (CI, 2%-42%). Worsened wound or ulcer was found at 35% (CI, 10%-62%). There was a trend toward improvement in mortality and amputation rate in studies done after 1997. The quality of evidence was low because of increased risk of bias and inconsistency., Conclusions: Mortality and major amputations are common in patients who have untreated CLI during a median follow-up of 1 year, although these outcomes have improved in recent times., (Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The aim of this systematic review was to synthesize the existing evidence about various nonrevascularization-based therapies used to treat patients with severe or critical limb ischemia (CLI) who are not candidates for surgical revascularization., Methods: We systematically searched multiple databases through November 2014 for controlled randomized and nonrandomized studies comparing the effect of medical therapies (prostaglandin E1 and angiogenic growth factors) and devices (pumps and spinal cord stimulators). We report odds ratios (ORs) and 95% confidence intervals (CIs) of the outcomes of interest pooling data across studies using the random effects model., Results: We included 19 studies that enrolled 2779 patients. None of the nonrevascularization-based treatments were associated with a significant effect on mortality. Intermittent pneumatic compression (OR, 0.14; 95% CI, 0.04-0.55) and spinal cord stimulators (OR, 0.53; 95% CI, 0.36-0.79) were associated with reduced risk of amputation. A priori established subgroup analyses (combined vs single therapy; randomized vs nonrandomized) were not statistically significant., Conclusions: Very low-quality evidence, mainly due to imprecision and increased risk of bias, suggests that intermittent pneumatic compression and spinal cord stimulators may reduce the risk of amputations. Evidence supporting other medical therapies is insufficient., (Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)