BEST-CLI (cohort 2)
Trial question
What is the role of surgery in patients with chronic limb-threatening ischemia who lacked an adequate saphenous vein conduit?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
28.0% female
72.0% male
N = 396
396 patients (111 female, 285 male).
Inclusion criteria: patients with chronic limb-threatening ischemia who lacked an adequate saphenous vein conduit.
Key exclusion criteria: excessive risk associated with open vascular surgery according to the AHA/ACC criteria or to the judgement of the investigator.
Interventions
N=197 surgery (surgical revascularization using an alternative vein bypass conduit).
N=199 endovascular therapy (endovascular therapy using a technique as per the interventionalist's choice).
Primary outcome
Major adverse limb events or death from any cause
42.8%
47.7%
47.7 %
35.8 %
23.9 %
11.9 %
0.0 %
Surgery
Endovascular
therapy
No significant
difference ↔
No significant difference in major adverse limb events or death from any cause (42.8% vs. 47.7%; HR 0.79, 95% CI 0.58 to 1.06).
Secondary outcomes
No significant difference in death from any cause (26.3% vs. 24.1%; HR 1.15, 95% CI 0.77 to 1.72).
No significant difference in above-ankle amputation of the index limb (14.9% vs. 14.1%; HR 1.1, 95% CI 0.65 to 1.87).
Significant decrease in major reintervention on the index limb (14.4% vs. 25.6%; HR 0.47, 95% CI 0.29 to 0.76).
Safety outcomes
No significant difference in major adverse CV events and serious adverse events.
Conclusion
In patients with chronic limb-threatening ischemia who lacked an adequate saphenous vein conduit, surgery was not superior to endovascular therapy with respect to major adverse limb events or death from any cause.
Reference
Alik Farber, Matthew T Menard, Michael S Conte et al. Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia. N Engl J Med. 2022 Dec 22;387(25):2305-2316.
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