A Novel Score Predicts Need of Open Revascularization Following Endovascular Revascularization in Patients with Infrainguinal Chronic Limb-threatening Ischemia

Abstract

This study aims to assess the ability of a novel score, the infrainguinal successful endovascular treatment (iSET) score in predicting risk of open revascularization in patients undergoing endovascular revascularization (ER) for infrainguinal chronic limb-threatening ischemia (CLTI). A retrospective analysis of consecutive patients undergoing ER for CLTI between January 2015 and December 2018. The iSET is a score between 1 and 63. It combines components of the Global Vascular Guidelines evidence-based revascularization as follows: iSET = Wound, Ischemia, foot Infection (WIfI) × WIFI + inflow disease + 4 × Global limb anatomic staging system (GLASS) FP + 6 × GLASS IP + 3 × IM pedal modifier. It stratifies patients into low (0-21), moderate (22-42), and high (43-63). The primary outcome was freedom from open revascularization at 2 years. Secondary outcomes were 30-day and 1-year endovascular reintervention, major amputations (above the ankle joint), minor amputations (below the ankle joint) and mortality. Kaplan-Meier estimates and Cox proportional hazard model assessed ability of iSET to predict open revascularization risk. A P value < .05 was significant. The study included 159 limbs in 150 patients with 12% (n = 19), 53% (n = 84), and 35% (n = 56) having a low, moderate, and high iSET scores, respectively. Most patients presented with tissue loss (86%), WIfI stage 4 (64%), and GLASS III (47%). Patients with a high iSET were more likely to have received antibiotics prior to ER (odds ratio, 1.35; 95% confidence interval [CI], 1.08-1.70; P = .013) and less likely to have elective ER (odds ratio, 0.36; 95% CI, 0.18-0.72; P = .003). Most ER involved the femoropopliteal segment (84%), with 55% of these including concomitant infrapopliteal revascularization. Kaplan-Meier survival curves showed that 2-year freedom from open revascularization was 100%, 93%, and 79% with low, moderate, and high iSET, respectively (Fig). Mortality, reinterventions, and major amputations were similar at 30 days and 1 year (Table). There was an increase in minor amputations at 1 year with high iSET patients (38%; n = 20) compared with low (6%; n = 1) and moderate (21%; n = 15) iSET (P = .016). High iSET score predicted increased risk of open revascularization (hazard ratio, 4.75; 95% CI, 1.67-13.48; P = .003). The iSET is a novel comprehensive score incorporating guideline-driven parameters. The score correlated significantly with ER failure at 2 years with progressively lower freedom from open revascularization between low, moderate, and high iSET scores. Additionally, a high iSET score independently predicted subsequent open revascularization after ER. Further studies are needed to validate it as an adjunctive decision-making tool in patients with CLTI.TableThirty-day and 1-year outcomes in patients stratified by groupsOverallLowModerateHighP-value30-day Death2 (3)03 (2)2 (1).775 Endovascular reintervention8 (11)08 (6)10 (5).447 Major amputation2 (2)02 (1)3 (1).848 Minor amputation13 (18)6 (1)8 (6)21 (11).0861-year Death11 (15)013 (9)11 (6).334 Endovascular reintervention34 (48)31 (5)33 (24)37 (19).885 Major amputation13 (18)014 (10)15 (8).262 Minor amputation25 (36)6 (1)21 (15)38 (20).016Data is presented as percentage (number). Open table in a new tab