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Patients with chronic limb-threatening ischemia (CLTI) require revascularization to improve limb perfusion and thereby limit the risk of amputation. It is uncertain whether an initial strategy of endovascular therapy or surgical revascularization for CLTI is superior for improving limb outcomes.In this international, randomized trial, we enrolled 1830 patients with CLTI and infrainguinal peripheral artery disease in two parallel-cohort trials. Patients who had a single segment of great saphenous vein that could be used for surgery were assigned to cohort 1. Patients who needed an alternative bypass conduit were assigned to cohort 2. The primary outcome was a composite of a major adverse limb event - which was defined as amputation above the ankle or a major limb reintervention (a new bypass graft or graft revision, thrombectomy, or thrombolysis) - or death from any cause.In cohort 1, after a median follow-up of 2.7 years, a primary-outcome event occurred in 302 of 709 patients (42.6%) in the surgical group and in 408 of 711 patients (57.4%) in the endovascular group (hazard ratio, 0.68; 95% confidence interval [CI], 0.59 to 0.79; P0.001). In cohort 2, a primary-outcome event occurred in 83 of 194 patients (42.8%) in the surgical group and in 95 of 199 patients (47.7%) in the endovascular group (hazard ratio, 0.79; 95% CI, 0.58 to 1.06; P = 0.12) after a median follow-up of 1.6 years. The incidence of adverse events was similar in the two groups in the two cohorts.Among patients with CLTI who had an adequate great saphenous vein for surgical revascularization (cohort 1), the incidence of a major adverse limb event or death was significantly lower in the surgical group than in the endovascular group. Among the patients who lacked an adequate saphenous vein conduit (cohort 2), the outcomes in the two groups were similar. (Funded by the National Heart, Lung, and Blood Institute; BEST-CLI ClinicalTrials.gov number, NCT02060630.).

WIfI stage measures the extent of wounds, ischemia, and foot infection in patients with chronic limb threatening ischemia (CLTI) and has been associated with risk of major amputation. Patients with CLTI have impaired health-related quality of life (HRQoL), which may be multifactorial in nature. We hypothesize that severity of limb threat (WIfI) is associated with poor QoL among patients with CLTI presenting for revascularization.The dataset of the Best Endovascular versus Best Surgical Therapy in Patients with CLTI (BEST-CLI) trial, a prospective randomized trial comparing open and endovascular revascularization strategies, was queried for HRQoL assessment at time of patient enrollment. HRQOL assessments included (1) Vascular Quality of Life (VascuQoL), (2) SF-12, containing (a) utility index score (SF-6D-R2) - incorporating physical, emotional, and mental wellbeing, (b) mental (MCS) and (c) physical (PCS) components, and (3) EQ-5D. Multivariable regression analysis was used to identify independent associations with baseline HRQoL assessments.There were 1568 patients with complete WIfI data analyzed, of which 71.5% were male. WIfI distribution was 35.5% stage 4, 29.6% stage 3, 28.6% stage 2, and 6.3% stage 1 patients. Patients presenting with WIfI stage 4, compared to stages 1-3, were more often male (74.9% vs. 69.6%), current smokers (25.4% vs. 17.6%), had end stage renal disease (13.3% vs. 8.5%), diabetes (83.6% vs. 60.2%), were not independently ambulatory (56.8% vs. 38.5%), and had higher median morbidity score (4 vs. 3) (P.05 for all). On multivariable analysis, WIfI stage 4, compared to stages 1-3, was associated with lower SF-12 MCS (-2.43, 95% CI -3.73, -1.13, P.001) and SF6D-R2 Utility index scores (-.02, 95% CI -.03-.001, P=.04). WIfI stage was not independently associated with baseline VascuQoL, SF-12 PCS, or EQ-5D assessment.WIfI stage is independently associated with poorer quality of life due to mental rather than physical health in patients with CLTI. Clinicians should be aware of the burden of mental stress borne by those with greatest limb impairment.