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Validation Of BEST-CLI Among Patients Undergoing Primary Bypass Or Angioplasty +/- Stenting For CLTI
Jeremy D. Darling, MD, MS, Camila R. Guetter, MD, MPH, Jemin Park, MD, Elisa Caron, MD, Isa F. van Galen, MD, Patric Liang, MD, Lars Stangenberg, MD, PhD, Allen D. Hamdan, MD, Mark C. Wyers, MD, Marc L. Schermerhorn, MD.
Beth Israel Deaconess Medical Center, Boston, MA, USA.
OBJECTIVES: 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 limited. Thus, we aimed to internally validate the long-term results of angioplasty +/- stenting (PTA/S) versus bypass (BPG) using 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, including complete wound healing, major adverse limb events (MALE), major amputation/death, and MALE/death, were evaluated using Kaplan-Meier estimates and Logrank 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, 842 fit Cohort 1 (421 BPG and 421 PTA/S) and 272 fit Cohort 2 (136 BPG and 136 PTA/S). Both cohorts exhibited a median follow-up of 2.7 years. In Cohort 1, MALE and MALE/death were both noted to be significantly decreased following ssGSV BPG, as compared to PTA/S (at 5 years, 51% vs. 60% and 75% vs 79%, respectively; both p<.01) (Figure I). These findings correlated with a 29% and 20% reduction in the aforementioned events (HR 0.71, 95%CI [0.57-0.88] and 0.80 [0.68-0.94], respectively). These significant differences in MALE and MALE/death were not noted in Cohort 2 (at 5 years, 58% vs. 50% and 79% vs. 72%, respectively; p>.05). Further, neither Cohort demonstrated significant differences in complete wound healing rates (at 6 months, Cohort 1: 47% vs. 42%; Cohort 2: 42% vs. 42%) or major amputation/death (at 5 years, Cohort 1: 59% vs. 60%; Cohort 2: 63% vs. 58%) (all p>.05).
CONCLUSIONS: Patients with CLTI undergoing a first-time revascularization using single-segment great saphenous vein demonstrate significantly lower rates of MALE and MALE/Death compared to those undergoing endovascular interventions. However, similar outcomes are not seen among patients undergoing a first-time revascularization without a suitable ssGSV. These findings correlate with those demonstrated in BEST-CLI, suggesting generalizability.
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