Validation of BEST-CLI among patients undergoing primary bypass or angioplasty with or without stenting for chronic limb-threatening ischemia.

Abstract

Background: BEST-CLI established the superiority of single-segment great saphenous vein (ssGSV) conduits for revascularization in patients with CLTI; however, the generalizability of these data is unknown. Thus, we aimed to validate the long-term results of open surgical bypass (BPG) versus angioplasty with or without stenting (PTA/S) using the BEST-CLI inclusion and randomization criteria.

Methods: All patients undergoing a first-time lower extremity revascularization for CLTI at our institution from 2005 to 2022 were retrospectively reviewed. To approximate BEST-CLI, one-to-one propensity score matching was used. Cohort 1 included BPG with ssGSV versus PTA/S; Cohort 2 included BPG without ssGSV versus PTA/S. Primary outcomes included wound healing, major amputation, major reintervention, major amputation/death (Amputation/Death), and major adverse limb events (MALE) or Death (MALE/Death) and were evaluated using Kaplan-Meier estimates and log-rank tests.

Results: Of 1,946 limbs undergoing a first-time intervention for CLTI between 2005-2022, 765 underwent BPG and 1181 underwent PTA/S. After matching, 862 fit Cohort 1 (431 BPG and 431 PTA/S) and 274 fit Cohort 2 (137 BPG and 137 PTA/S). Both cohorts exhibited a median follow-up of 2.7 years. In Cohort 1, major reintervention and MALE/death were both noted to be significantly lower following ssGSV BPG, as compared to PTA/S (at 7 years: 11% vs. 24%, p=.001 and 72% vs. 78%, p=.03, respectively). These findings correlated with a 53% and 28% reduction in the aforementioned adjusted events (HR 0.47, 95% CI [0.30-0.74] and 0.82 [0.69-0.98], respectively). These significant differences in major reintervention and MALE/Death were not noted in Cohort 2 (at 7 years: 25% vs. 24%, p=.92 and 82% vs. 80%, p=.31, respectively). Further, neither Cohort demonstrated significant differences in complete wound healing (at 6 months, Cohort 1: 47% vs. 40%, p=.32; Cohort 2: 40% vs. 38%, p=.12), major amputation (at 7 years: Cohort 1: 15% vs. 15%, p=.89; Cohort 2: 35% vs. 25%, p=.86), or Amputation/Death (at 7 years, Cohort 1: 70% vs. 66%, p=.99; Cohort 2: 78% vs. 76%, p=.45).

Conclusions: Patients undergoing revascularization using single-segment great saphenous vein demonstrate significantly lower rates of major reintervention and MALE/Death compared with those undergoing endovascular interventions for CLTI. However, similar outcomes are not seen among patients undergoing revascularization without a suitable ssGSV. These findings correlate with those demonstrated in BEST-CLI, suggesting generalizability.