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Editor's Choice - Reduction of Major Amputations after Surgery versus Endovascular Intervention: The BEST-CLI
Maarit A Venermo1, Alik Farber2, Andres Schanzer3
1Department of Vascular Surgery, Helsinki University Central Hospital, Helsinki, Finland.
Insights
Surgical bypass using single segment great saphenous vein (SSGSV) significantly reduced major amputations in chronic limb threatening ischemia (CLTI) patients compared to endovascular treatment. This was primarily due to fewer subsequent major amputations after initial procedures.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Limb Salvage Procedures
Background:
- Chronic limb-threatening ischemia (CLTI) presents a significant challenge in vascular care.
- Treatment options include surgical bypass and endovascular revascularization.
- Optimal treatment strategy to prevent amputation remains under investigation.
Purpose of the Study:
- To evaluate amputation rates and the risk of major amputation in a substudy of the BEST-CLI trial.
- To compare outcomes between surgical bypass and endovascular treatment in CLTI patients.
- To analyze initial and subsequent amputation events.
Main Methods:
- A substudy of the BEST-CLI randomized trial involving 1,830 CLTI patients.
- Patients were randomized into two cohorts based on great saphenous vein availability.
- Cohort 1 (n=1,434) with adequate SSGSV, Cohort 2 (n=396) without adequate SSGSV.
- Outcomes assessed included time to first event and amputation rates.
Main Results:
- In Cohort 1, surgical bypass showed significantly lower overall amputation events (45.6% vs. 54.4%, p=.001) and subsequent major amputations (15.0% vs. 25.6%, p=.002) compared to endovascular treatment.
- No significant difference in initial major amputations was observed between groups.
- In Cohort 2, no significant difference in amputation events or major amputations was found between surgical and endovascular groups.
Conclusions:
- Surgical bypass utilizing SSGSV is more effective in preventing major amputations in CLTI patients than endovascular treatment.
- The benefit of surgical bypass is largely attributed to a reduction in major amputations that occur subsequent to minor amputations.
- Treatment decisions should consider vein availability and potential for limb salvage.
Objective:
BEST-CLI, an international randomised trial, compared an initial strategy of bypass surgery with endovascular treatment in chronic limb threatening ischaemia (CLTI). In this substudy, overall amputation rates and risk of major amputation as an initial or subsequent outcome were evaluated.
Methods:
A total of 1 830 patients were randomised to receive surgical or endovascular treatment in two parallel cohorts: patients with adequate single segment great saphenous vein (SSGSV) (n = 1 434) were assigned to cohort 1; and patients without adequate SSGSV (n = 396) were assigned to cohort 2. Differences in time to first event and number of amputations were evaluated.
Results:
In cohort 1, there were 410 (45.6%) total amputation events in the surgical group vs. 490 (54.4%) in the endovascular group (p = .001) during a mean follow up of 2.7 years. Approximately one in three patients underwent minor amputation after index revascularisation: 31.5% of the surgical group vs. 34.9% in the endovascular group (p = .17). Subsequent major amputation was required significantly less often in the surgical group compared with the endovascular group (15.0% vs. 25.6%; p = .002). The first amputation was major in 5.6% of patients in the surgical group and 6.0% in the endovascular group (p = .72). Major amputation was required in 10.3% (74/718) of patients in the surgical group and 14.9% (107/716) in the endovascular group (p = .008). In cohort 2, there were 199 amputation events in 132 patients (33.3%) during a mean follow up of 1.6 years: 95 (47.7%) in the surgical group vs. 104 (52.3%) in the endovascular group (p = .49). Major amputation was required in 15.2% (30/197) of patients in the surgical group and 14.1% (28/199) in the endovascular group (p = .74).
Conclusion:
In patients with CLTI, surgical bypass with SSGSV was more effective than endovascular treatment in preventing major amputations, mainly due to a decrease in major amputations subsequent to minor amputations.
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