Expansion of Bypass As a Revascularization Option for Patients with Chronic Limb-Threatening Ischemia

In the Best Endovascular vs Best Surgical Therapy in Patients with Chronic Limb-Threatening Ischemia (BEST-CLI) multicenter (n = 150) trial, 1830 patients with chronic limbthreatening ischemia (CLTI) were enrolled between August 2014 and October 2019 into one of 2 parallel-trial cohorts. Cohort 1 (n = 1434) included patients who had a single segment of great saphenous vein that could be used for bypass surgery, whereas cohort 2 (n = 396) included patients who needed an alternative bypass conduit (e.g., a prosthetic conduit). Patients in both cohorts were randomized to either a surgical bypass or an endovascular intervention. The primary outcome was a composite of death from any cause or a major adverse limb event (amputation above the ankle or a major limb reintervention, e.g., graft revision, thrombectomy, angioplasty, stent, thrombolysis, or a new bypass graft). In cohort 1, after a median follow-up of 2.7 (interquartile range: 1.6–4.0) years, the incidence of a major adverse limb event or death was significantly lower among patients in the surgical vs the endovascular group (302/709 vs 408/711 patients, or 42.6 vs 57.4%, respectively; hazard ratio [HR]: .68; 95% confidence interval [CI]: .59-.79; P < .001). In contrast, in cohort 2, after a median follow-up of 1.6 (interquartile range: .7-2.8) years, the incidence of a major adverse limb event or death was similar between patients in the surgical and the endovascular groups (83/194 vs 95/199 patients, or 42.8 vs 47.7%, respectively; HR: .79; 95% CI: .58-1.06; P = .12). The BEST-CLI trial was a well-designed trial comparing surgical revascularization vs endovascular interventions in patients with CLTI. Patients were well-matched with respect to best medical treatment (BMT), including statins, antiplatelets and anticoagulants. Statins, in particular, are associated with several beneficial actions in patients with peripheral arterial disease (PAD), including improved limb salvage and overall survival rates. A major criticism of studies comparing surgical vs endovascular techniques for revascularization of lower limb arteries is that they do not evaluate the continuously evolving endovascular techniques. In the BEST-CLI, the endovascular techniques applied to CLTI patients included the use of atherectomy (15%), drug-coated balloons (25%) and drugeluting stents (22%). With wider application of advanced endovascular techniques, the outcomes of patients offered endovascular treatment are expected to improve. Thus, the BEST-CLI results may become outdated. A considerable difference in the incidence of reinterventions was noted between the surgical and the endovascular groups, particularly during the first 30 days post-procedurally when 99/ 233 (42.5%) of reinterventions took place. As the authors reported, this early increase in reinterventions may have been related to a greater incidence of initial technical failures in the endovascular compared with the surgical group (15 vs 2%, respectively; P < .001). With continuous advances in the endovascular technology, the increased expertise and the wider application of novel devices/techniques, the number of reinterventions in patients offered an endovascular-first approach are expected to decrease. One of the strengths of the BEST-CLI trial was that patients were well-matched with respect to comorbidities (i.e., hypertension, diabetes mellitus [DM], hyperlipidemia, smoking, coronary artery disease, and congestive heart failure). In particular DM is associated with a higher risk of all-cause mortality, major limb amputation, graft failures, and major adverse cardiovascular events in patients with lower extremity arterial disease. Furthermore, it has been reported that patients with DM are less frequently treated with stents and have higher target lesion complexity. A recent metaanalysis (31 studies; 58,813 patients) reported that the presence of DM is strongly associated with lower primary