BEST-CLI (cohort 1)
Trial question
What is the role of surgery in patients with chronic limb-threatening ischemia who had adequate great saphenous vein for surgical revascularization?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
28.0% female
72.0% male
N = 1434
1434 patients (408 female, 1026 male).
Inclusion criteria: patients with chronic limb-threatening ischemia who had adequate great saphenous vein for surgical revascularization.
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=718 surgery (surgical revascularization using a single segment of the great saphenous vein).
N=716 endovascular therapy (endovascular therapy using a technique as per the interventionalist's choice).
Primary outcome
Major adverse limb events or death from any cause
42.6%
57.4%
57.4 %
43.0 %
28.7 %
14.3 %
0.0 %
Surgery
Endovascular
therapy
Significant
decrease ▼
NNT = 6
Significant decrease in major adverse limb events or death from any cause (42.6% vs. 57.4%; HR 0.68, 95% CI 0.59 to 0.79).
Secondary outcomes
No significant difference in death from any cause (33% vs. 37.6%; HR 0.98, 95% CI 0.82 to 1.17).
Significant decrease in above-ankle amputation of the index limb (10.4% vs. 14.9%; HR 0.73, 95% CI 0.54 to 0.98).
Significant decrease in major adverse limb event or perioperative death (20.2% vs. 34.7%; HR 0.53, 95% CI 0.43 to 0.65).
Safety outcomes
No significant difference in major adverse CV events and serious adverse events.
Significant difference in serious adverse events during follow-up (3141 vs. 3468).
Conclusion
In patients with chronic limb-threatening ischemia who had adequate great saphenous vein for surgical revascularization, surgery was 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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