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P5: Plenary Session 5

SS14 - Generalizability of BASIL-2 in First-time Revascularizations for CLTI

Friday, June 6, 2025
8:48 AM – 8:59 AM CT
Location: Morial CC, First Floor, Great Hall A
Objectives: BASIL-2 demonstrated the superiority of an endovascular-first approach in patients with CLTI for the primary end-point of amputation-free survival (AFS); however, the generalizability of these data is unknown. Thus, we aimed to externally validate these findings by comparing open surgical bypass (BPG) to angioplasty +/- stenting (PTA/S) using the BASIL-2 inclusion and randomization criteria.

Methods: All patients undergoing a first-time lower extremity infrapopliteal revascularization for CLTI at our institution from 2005-2022 were retrospectively reviewed. To approximate BASIL-2, one-to-one propensity matching was performed. The primary outcome was AFS; secondary outcomes included major reintervention, major amputation, major adverse limb events (MALE), and survival. A sensitivity analysis was performed assessing the same PTA/S cohort versus BPG with single-segment great saphenous vein (ssGSV) conduits. Outcomes were evaluated using chi-squared, Kaplan-Meier, and Cox regression analyses.

Results: Of 1,184 limbs undergoing a first-time infrapopliteal intervention for CLTI between 2005-2022, 492 underwent BPG and 692 underwent PTA/S. After matching, 620 patients (310 BPG and 310 PTA/S) fit our criteria, with no baseline differences noted between groups. Between BPG and PTA/S, the mean age was 71.0 years in both groups, with similar rates of male sex (66% vs. 65%), white race (75% vs. 75%), CAD (52% vs. 49%), diabetes (77% vs. 75%), chronic kidney disease (29% vs. 34%), dialysis dependence (19% vs. 17%), and smoking history (66% vs. 65%) (all p>.05). There were no differences in perioperative mortality (3.9% vs. 4.5%), stroke (0.0% vs. 1.1%), myocardial infarction (1.3% vs. 2.9%), or acute kidney injury (12% vs. 14%) (all p>.05). BPG, as compared to PTA/S, did not demonstrate any difference in AFS (at five years: 36% vs. 39%, p=.77), major reintervention (15% vs. 19%, p=.06), major amputation (24% vs. 22%, p=.75), MALE (32% vs. 36%, p=.08), or survival (42% vs. 47%, p=.56) (Table I). When limiting the BPG group to only ssGSV conduits (n=267), despite no difference seen in AFS (32% vs. 36%, p=.99), we noted significantly lower rates of major reintervention (12% vs. 19%) and MALE (29% vs. 36%) (Fig I), demonstrating a 48% and 31% risk reduction, respectively (HR 0.52, 95% CI 0.30-0.89 and 0.69[0.49-0.98]).

Conclusions: Among patients undergoing infrapopliteal revascularization for CLTI, BPG and PTA/S do not differ in regard to AFS, raising concerns regarding the generalizability of BASIL-2. Importantly, infrapopliteal interventions following ssGSV BPG, as compared to PTA/S, do demonstrate significantly lower rates of major reintervention and MALE, reinforcing the benefits of this conduit in patients with CLTI.