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Updated: Jun 1, 2025
Predicting Amputation using Local Circulating Mononuclear Progenitor Cells in Angioplasty-treated Patients with Critical Limb Ischemia
Published on: September 22, 2020
Validation of BEST-CLI among patients undergoing primary bypass or angioplasty with or without stenting for chronic
Jeremy D Darling1, Camila R Guetter1, Jemin Park1
1Division of Vascular and Endovascular Surgery, Department of Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.
Insights
Single-segment great saphenous vein bypasses significantly reduce reintervention and adverse limb events in chronic limb-threatening ischemia patients. These findings validate previous studies, confirming the generalizability of using ssGSV for revascularization.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Limb Salvage Procedures
Background:
- Chronic limb-threatening ischemia (CLTI) poses a significant risk of amputation.
- The BEST-CLI trial demonstrated the superiority of single-segment great saphenous vein (ssGSV) bypasses over endovascular therapy for CLTI.
- Generalizability of BEST-CLI findings to real-world practice remains to be established.
Purpose of the Study:
- To validate the long-term outcomes of open surgical bypass (BPG) using ssGSV compared to percutaneous transluminal angioplasty with or without stenting (PTA/S) in CLTI patients.
- To assess the generalizability of BEST-CLI findings by applying its inclusion and randomization criteria retrospectively.
- To compare revascularization strategies based on the availability of ssGSV conduits.
Main Methods:
- Retrospective review of 1946 CLTI patients undergoing first-time revascularization (2005-2022).
- One-to-one propensity score matching to create two cohorts: BPG with ssGSV vs. PTA/S, and BPG without ssGSV vs. PTA/S.
- Kaplan-Meier estimates and log-rank tests were used to evaluate wound healing, amputation, reintervention, and major adverse limb events (MALE) or death.
Main Results:
- In the cohort using ssGSV bypass, significantly lower rates of major reintervention (11% vs. 24% at 7 years) and MALE/death (72% vs. 78% at 7 years) were observed compared to PTA/S.
- These improvements translated to a 53% and 28% reduction in adjusted events, respectively, for ssGSV BPG.
- No significant differences in reintervention or MALE/death were found in the cohort without ssGSV bypass; wound healing and amputation rates were similar across all groups.
Conclusions:
- Revascularization with ssGSV bypass significantly lowers major reintervention and MALE/death rates in CLTI patients compared to endovascular therapy.
- Outcomes are not replicated when ssGSV is unavailable, highlighting the importance of conduit selection.
- These findings support the generalizability of BEST-CLI results, emphasizing the role of ssGSV in CLTI management.
Objective:
BEST-CLI established the superiority of single-segment great saphenous vein (ssGSV) conduits for revascularization in patients with chronic limb-threatening ischemia (CLTI); however, the generalizability of these data is unknown. Thus, we aimed to validate the long-term results of open surgical bypass (BPG) vs percutaneous transluminal 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 vs PTA/S; Cohort 2 included BPG without ssGSV vs 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 1946 limbs undergoing a first-time intervention for CLTI between 2005 and 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 with 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 (hazard ratio, 0.47; 95% confidence interval, 0.30-0.74 and hazard ratio, 0.82; 95% confidence interval, 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 ssGSV 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.
