Critical lower limb ischemia (CLLI) is associated with a major deterioration in quality of life and a significant increase in morbidity and mortality. Its estimated annual incidence is 220 to 3500 cases per million people, with an expected prevalence of 11% of patients with peripheral arterial disease.
CLLI is the “terminal” stage of peripheral artery disease, and, as time goes by, it offers an increased risk of amputation, with an incidence of 25% one year after diagnosis. Current treatment is based on medication to reduce cardiovascular risk, revascularization to improve perfusion, and local control of the affected tissue for infection control or wound repair.
The aim of this research (BEST-CLI) was to determine whether endovascular revascularization is superior to surgical revascularization in patients with CLLI caused by infra inguinal peripheral arterial disease who were candidates for both procedures.
A prospective, randomized, multicenter, superiority study was conducted across 150 centers in North America and Europe. Two cohorts were studied, one with the possibility of using a great saphenous vein as a conduit (Cohort 1), and another in which an alternative conduit was used (Cohort 2).
Patients included had a diagnosis of CLLI (pain at rest, non-healed ulcer or gangrene), while patients with high surgical risk for the procedure were excluded. Randomization was 1:1. Follow-up was up to 84 months after randomization.
The primary endpoint (PEP) was a composite of major adverse limb events (above-ankle amputation, new bypass, thrombectomy, or thrombolysis) or all-cause mortality. Efficacy and safety endpoints were major limb event, perioperative death at 30 days, minor reinterventions, or a major cardiovascular event (acute myocardial infarction, stroke, or death).
Cohort 1 followed 1434 patients with the possibility of major saphenous vein use (718 underwent bypass surgery and 716 endovascular treatment) with a mean follow-up of 2.8 years. The mean age was 66.9 years, 70% of patients had diabetes, and 36% were smokers.
For the surgical patients, 307 femoropopliteal, 276 femorotibial or pedal, and 115 popliteal or pedal (98% technical success) bypass surgeries were performed. The endovascular approach was implemented in 487 cases on the superficial femoral artery (SFA), 382 in the popliteal artery, and 381 the infrapopliteal artery, mainly with balloon revascularization (85% technical success).
The PEP was reached in 42.6% of surgical patients and 57.4% of endovascular patients (hazard ratio [HR]: 0.68; 95% confidence interval [CI]: 0.59-0.79; p < 0.001). Major reinterventions occurred in 9.2% of surgeries and in 23. 5% of angioplasties (HR: 0.35; 95% CI: 0.27-0.47), and 10.4% of surgical patients were amputated at follow-up compared with 14.9% of patients in the endovascular arm (HR: 0.73, 95% CI: 0.54-0.98).
In the subgroup analysis, results were similar, except in patients >80 years, patients who were black, and patients with previous homolateral revascularization or renal impairment.
At follow-up, 40% of the patients enrolled experienced major adverse cardiac events (MACE), with no differences between the two types of treatment.
In cohort 2 (patients without optimal great saphenous vein), data were obtained from 396 patients, with a follow-up of 1.6 years. The surgical conduits chosen were the alternative autologous vein bypass in 48 cases and prosthesis in 119 cases, and there was a 19% use of the saphenous vein, which was viable intra-surgically. In the endovascular arm, angioplasty was conducted in the SFA in 133 cases, the popliteal artery in 114 cases, and the tibial or pedal vein. The PEP for surgery (42.8%) vs. endovascular (47.7%) did not present significant differences (HR: 0.79; 95% CI: 0.58-1.06; p = 0.12).
This international, pragmatic, large-cohort study is a step forward in the treatment of patients with CLLI, as reliable data were obtained 15 years after the publication of the flagship study on critical ischemia (BASIL).
These data speak in favor of planning an intervention in these patients, as the study showed that greater saphenous vein availability as a conduit presented fewer events. Patients who were not candidates for saphenous vein use, those who were >80 years of age or had renal impairment, did not present significant differences compared with endovascular treatment.
Dr. Omar Tupayachi.
Member of the Editorial Board of SOLACI.org.
Reference: Farber A, Menard MT, Conte MS, Kaufman JA, Rosenfield K, et al; BEST-CLI Investigators. Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia. N Engl J Med. 2022 Nov 7. doi: 10.1056/NEJMoa2207899. Epub ahead of print. PMID: 36342173.
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