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Background: Chronic limb-threatening ischaemia is the severest manifestation of peripheral arterial disease and presents with ischaemic pain at rest or tissue loss (ulceration, gangrene, or both), or both. We compared the effectiveness of a vein bypass first with a best endovascular treatment first revascularisation strategy in terms of preventing major amputation and death in patients with chronic limb threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularisation procedure to restore limb perfusion., Methods: Bypass versus Angioplasty for Severe Ischaemia of the Leg (BASIL)-2 was an open-label, pragmatic, multicentre, phase 3, randomised trial done at 41 vascular surgery units in the UK (n=39), Sweden (n=1), and Denmark (n=1). Eligible patients were those who presented to hospital-based vascular surgery units with chronic limb-threatening ischaemia due to atherosclerotic disease and who required an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularisation procedure to restore limb perfusion. Participants were randomly assigned (1:1) to receive either vein bypass (vein bypass group) or best endovascular treatment (best endovascular treatment group) as their first revascularisation procedure through a secure online randomisation system. Participants were excluded if they had ischaemic pain or tissue loss considered not to be primarily due to atherosclerotic peripheral artery disease. Most vein bypasses used the great saphenous vein and originated from the common or superficial femoral arteries. Most endovascular interventions comprised plain balloon angioplasty with selective use of plain or drug eluting stents. Participants were followed up for a minimum of 2 years. Data were collected locally at participating centres. In England, Wales, and Sweden, centralised databases were used to collect information on amputations and deaths. Data were analysed centrally at the Birmingham Clinical Trials Unit. The primary outcome was amputation-free survival defined as time to first major (above the ankle) amputation or death from any cause measured in the intention-to-treat population. Safety was assessed by monitoring serious adverse events up to 30-days after first revascularisation. The trial is registered with the ISRCTN registry, ISRCTN27728689., Findings: Between July 22, 2014, and Nov 30, 2020, 345 participants (65 [19%] women and 280 [81%] men; median age 72·5 years [62·7-79·3]) with chronic limb-threatening ischaemia were enrolled in the trial and randomly assigned: 172 (50%) to the vein bypass group and 173 (50%) to the best endovascular treatment group. Major amputation or death occurred in 108 (63%) of 172 patients in the vein bypass group and 92 (53%) of 173 patients in the best endovascular treatment group (adjusted hazard ratio [HR] 1·35 [95% CI 1·02-1·80]; p=0·037). 91 (53%) of 172 patients in the vein bypass group and 77 (45%) of 173 patients in the best endovascular treatment group died (adjusted HR 1·37 [95% CI 1·00-1·87]). In both groups the most common causes of morbidity and death, including that occurring within 30 days of their first revascularisation, were cardiovascular (61 deaths in the vein bypass group and 49 in the best endovascular treatment group) and respiratory events (25 deaths in the vein bypass group and 23 in the best endovascular treatment group; number of cardiovascular and respiratory deaths were not mutually exclusive)., Interpretation: In the BASIL-2 trial, a best endovascular treatment first revascularisation strategy was associated with a better amputation-free survival, which was largely driven by fewer deaths in the best endovascular treatment group. These data suggest that more patients with chronic limb-threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularisation procedure to restore limb perfusion should be considered for a best endovascular treatment first revascularisation strategy., Funding: UK National Institute of Health Research Health Technology Programme., Competing Interests: Declaration of interests AWB reports salary part paid by a National Institute for Health (NIHR) and Care Research Health Technology Assessment (HTA) BASIL-2 grant; payment expert advice and testimony from NHS Resolution, His Majesty's Coroners, National Crime Agency, UK, Scotland, Wales, and Northern Ireland Governments, and various law firms, outside of the submitted work; and payment to his institution and personal honoraria for committee work from NIHR HTA and NICE. GRB reports salary part paid by a NIHR HTA BASIL-2 grant; the BASIL-2 grant also paid mileage for visiting patients in the BASIL-2 trial for follow-up assessments. AD reports honoraria from Boston Scientific, Cordis, Medalliance, and Abbott. KH reports honoraria from Le Maitre and Bayer. STR reports payment for expert testimony from McCollum Consultants; consulting fees from 3M, Bayer, and Avita; speaker fees from 3M, Bayer, Avita, and Terumo; travel support Bayer and Terumo; and is an advisory board member for 3M, Bayer, and Avita. AS reports honoraria and institutional grant support from Shockwave and Abbott and unpaid committee work for NICE. HZ reports an institutional grant from Abbott and honoraria from Limflow, Abbott, Boston Scientific, Bentley, Cook Medical, and Medtronic. All other authors declare no competing interests., (Copyright © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Background: The Global Limb Anatomic Staging System (GLASS) is a new method of quantifying the anatomic severity of infrainguinal disease in patients with chronic limb-threatening ischemia. However, because GLASS has undergone limited validation, its value as an aid to shared decision-making regarding the choice of revascularization strategy remains incompletely defined. Here we report the relationship between GLASS and outcomes in a contemporary series comprising all 309 patients who underwent an attempt at femoropopliteal and/or infrapopiteal endovascular therapy for chronic limb-threatening ischemia in our unit between 2009 and 2014., Methods: Baseline patient characteristics and outcome data including immediate technical success (ITS), amputation-free survival (AFS), overall survival, limb salvage, freedom from reintervention (FF-R), and freedom from major adverse limb events (FF-MALE) were obtained from hospital databases. GLASS grades and stage were obtained from pre-endovascular therapy angiographic imaging. Outcome data were censored on May 31, 2017., Results: Baseline patient characteristics were similar across different GLASS femoropopliteal and IP grades and overall limb stages. Worsening GLASS stage was associated with a significant reduction in ITS (97.5% vs 91.5% vs 84.0%; P = .029). At 72 months FF-R (hazard ratio, 2.00; 95% confidence interval, 1.11-3.57; P = .020) and FF-MALE (hazard ratio, 1.76, 95% confidence interval, 1.10-2.81; P = .019) were significant worse in GLASS stage 3 than in stage 2 limbs., Conclusions: In our study, there were significant differences in ITS, FF-R and FF-MALE between limbs with GLASS stage 2 and 3 disease. However, further GLASS refinement seems likely to be required if its usefulness in everyday clinical practice as an aid to shared decision-making regarding the choice of revascularization strategy is to be maximized., (Copyright © 2022 Society for Vascular Surgery. All rights reserved.)

Background: Since the turn of the millennium, there has been a worldwide trend towards an endovascular-first strategy where possible revascularization strategy for chronic limb-threatening ischemia. There is concern that this may be inappropriate and can result in net patient harm. The aim of this study, therefore, is to compare important clinical outcomes following femoropopliteal plain balloon angioplasty (FP-PBA), with selective use of bare metal stents (BMSs), in a contemporary series (CS) of patients treated in our unit between 2009 and 2014 with those observed following FP-PBA ± BMS in the United Kingdom National Institute of Health Research Health Technology Assessment-funded Bypass vs Angioplasty in Severe Ischaemia of the Leg (BASIL-1 [B1]) trial (treated 1999-2004)., Methods: Baseline and clinical outcome data (amputation-free survival [AFS], overall survival [OS], limb salvage, freedom from reintervention, and freedom from major adverse limb events) were obtained from prospectively gathered hospital data and B1 trial case record forms., Results: There were 237 CS and 218 B1 patients. CS patients were older (77 vs 73 years; P = .0002). B1 patients were more likely to be current smokers, less likely to be on best medical therapy, and underwent more extensive endovascular interventions. CS had more hospital admissions (4 vs 2; P < .0001) before they reached their primary endpoint (AFS). Immediate technical success was nonsignificantly higher in the CS patients (87% vs 83%; P = .2). BMS were used in 20 CS (8%) and 2 B1 (1%) patients (P = .0002). AFS (hazard ratio, 0.64; 95% confidence interval, 0.49-0.82; P = .0005) and OS (hazard ratio, 0.58; 95% confidence interval, 0.44-0.76; P = .0001) were significantly worse in the CS cohort. There was no significant difference in limb salvage, freedom from reintervention, or freedom from major adverse limb events., Conclusions: Patients with chronic limb-threatening ischemia managed in our unit (2009-2014) by means of a FP-PBA ± BMS first (where possible) revascularization strategy experienced significantly worse AFS and OS than patients treated with FP-PBA ± BMS in the B1 trial 10 years earlier (1999-2004)., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The Global Vascular Guideline on chronic limb threatening ischaemia (CLTI) has introduced the Global Limb Anatomic Staging System (GLASS) as a new angiographic scoring system. However, the relationship between GLASS and outcomes following revascularisation has not previously been studied., Methods: Using pre-intervention angiograms the relationship between GLASS and immediate technical failure (ITF), amputation free survival (AFS), limb salvage (LS), overall survival (OS), and freedom from major adverse limb events (FF-MALE) was examined in 377 patients undergoing endovascular therapy (EVT, n = 213) or bypass surgery (BS, n = 164) in the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL)-1 trial (randomised 1999-2004)., Results: There was no significant difference in GLASS between cohorts. There was a significant relationship between ITF and GLASS in EVT (I 14%, II 15%, III 28%, p = .049). GLASS was significantly related to AFS (hazard ratio [HR], 1.37; 95% CI 1.01-1.85; p = .042), LS (HR 1.96; 95 % CI 1.12-3.43; p = .018), and FF-MALE (HR 1.49; 95% CI 1.04-1.87; p = .028) in the EVT cohort. In BS patients, there was no relationship between GLASS and these outcomes. FF-MALE was significantly worse after EVT than BS in GLASS II (p = .038) and III (p = .001). Among the subgroup of patients with femoropopliteal (FP) disease (BS, n = 109 or EVT, n = 159), FF-MALE was significantly higher after BS than EVT (p < .001). The superiority of BS over EVT with increasing GLASS FP grade was greater in the analysis of patients using vein grafts., Conclusion: In the BASIL-1 cohort, GLASS is associated with outcomes following EVT but not BS. Although further validation in contemporary CLTI cohorts is required, GLASS seems likely be useful in shared decision making and for stratifying patients in future trials., (Copyright © 2020 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Background: Bypass surgery (BS) remains the gold standard revascularization strategy in patients with chronic limb-threatening ischemia (CLTI) owing to infrainguinal disease. The Bypass versus Angioplasty for Severe Ischaemia of the Leg (BASIL)-1 trial showed that, in patients with CLTI who survived for 2 years or more, BS resulted in better clinical outcomes. Despite this finding, there has been an increasing trend toward an endovascular-first approach to infrainguinal CLTI. Our aim was to investigate whether changes in practice have impacted the clinical outcomes of BS in our unit 10 years after BASIL-1., Methods: Data for patients who underwent femoropopliteal (FP) BS in BASIL-1 (1999-2004) were retrieved from trial case record forms. The comparator contemporary series (CS) comprised all patients undergoing FP BS for CLTI in our unit between 2009 and 2014. Demographic and clinical outcome data on patients in the CS were collected from the prospectively collected hospital electronic notes. Anatomic patterns of disease in the BASIL-1 and CS cohorts were scored using the Bollinger and GLASS criteria. Statistical analysis was performed in SAS v9.4., Results: There were 128 patients from BASIL-1 and 50 patients in the CS. Baseline age, gender, affected limb, and diabetes prevalence were similar, as were days spent in hospital out to 12 months and length of follow-up. BASIL-1 patients were more likely to be current smokers (P = .000) and had a higher creatinine (P = .04). The 30-day morbidity and mortality were higher in BASIL-1 (45.3% vs 22%; P = .004). There was no significant difference between BASIL-1 and CS with regard to run-off Bollinger (37.7 vs 32.1; P = .167) and IP GLASS (0 vs 0; P = .390) scores, with both groups having a median of two runoff vessels. Amputation-free survival (62% vs 28%; hazard ratio [HR], 1.86; 95% confidence interval [CI], 1.18-2.93; P = .007), limb salvage (85% vs 69%; HR, 2.31; 95% CI, 1.14-4.68; P = .02), overall survival (69% vs 35%; HR, 1.66; 95% CI, 1.00-2.74; P = .05) and major adverse limb events (67% vs 47%; HR, 1.93; 95% CI, 1.15-3.22; P = .01) were all significantly better in BASIL-1., Conclusions: Although 30-day mortality and morbidity were significantly lower, all of the examined longer term clinical outcomes after FP BS were significantly worse in the CS group a decade on from BASIL-1. Further research in the form of prospective cohort studies and randomized controlled trials is urgently required to determine if the CS data reported herein are generalizable to current vascular surgical practice and, if so, to determine the reasons for these unexpected outcomes., (Copyright © 2018 Society for Vascular Surgery. All rights reserved.)

Objective: The aim was to compare outcomes in a subgroup of patients with infrapopliteal (IP) disease randomised to infrapopliteal vein bypass (VB) or plain balloon angioplasty (PBA) in the original BASIL trial., Methods: A comparison of outcomes from patients randomised to VB or PBA undergoing revascularisation for severe limb ischaemia (SLI) because of IP disease with or without femoropopliteal disease. Data were extracted from case report forms from the BASIL trial. The primary outcome was amputation free survival (AFS); secondary outcomes included overall survival (OS), 30 day mortality and morbidity, freedom from arterial re-intervention, immediate technical success, repeat and crossover interventions, length of hospital stay, and quality of revascularisation., Results: A total of 104 patients were identified in the BASIL study with IP disease, 56 randomised to IP VB, and 48 to IP PBA. Groups were similar at baseline except for more chronic kidney disease and non-steroidal anti-inflammatory drug use in the VB group, and more previous surgical arterial intervention and antihypertensive use in the PBA group. There were no statistically significant differences in AFS or OS; however, clinically important trends were apparent in favour of a VB first strategy. Patients allocated to VB demonstrated significantly quicker relief of rest pain when compared with PBA (p = .005), but no significant differences in improved tissue healing. Median length of index hospital admission was significantly greater in the VB than in the PBA group (18 vs. 10 days, p < .0001) but there was no difference between the two groups in median total hospital stay between randomisation and the primary endpoint (VB 43.5 vs. PBA 42 days)., Conclusions: Further randomised trials, like BASIL-2 and BEST-CLI, are required to determine whether patients with severe limb ischaemia who require IP revascularisation and who are suitable for VB should have bypass or endovascular intervention as their primary revascularisation procedure., (Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.)