The Incidence and Consequences of Endovascular Technical Failure in Patients with Chronic Limb-Threatening Ischemia: Results from the Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb-Threatening Ischemia (BEST-CLI) Trial

Abstract

Purpose: To analyze the causes and clinical impacts of endovascular technical failure (ETF) in the Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb-Threatening Ischemia (BEST-CLI) trial, which compared endovascular therapy with bypass surgery in patients with chronic limb-threatening ischemia (CLTI).

Materials and methods: Patients with CLTI were randomized to infrainguinal bypass or endovascular therapy. ETF was defined as the inability to complete the endovascular procedure. Patients with ETF were compared with those without ETF. Causes of ETF and impact on major adverse limb event (MALE), above-ankle amputation, and death were analyzed. ETF occurred in 16% (146 of 896) of endovascular procedures.

Results: Patients who experienced ETF were older (69 years [SD ± 10] vs 67 years [SD ± 10], P = .007), were less frequently Hispanic, and had more complex infrainguinal arterial occlusive disease than those without ETF. ETF had more multilevel arterial occlusions involving a combination of both the superficial femoral artery (SFA)/popliteal segments and tibial segments (52% vs 41%, P = .029); Wound, Ischemia, and foot Infection (WIfI) ischemia Grade 3 (70.3% vs 53.1%, P = .002); and occlusion of the proximal SFA (37% vs 19%, P < .001). Causes of ETF included inability to cross the lesion in 82%. Following ETF, 67% underwent bypass surgery within 2 weeks of ETF. ETF was associated with a higher rate of MALE (81% vs 29%, P < .001) but similar rates of above-ankle amputation (18.7% vs 16.0%, P = .528) and all-cause death (38.6% vs 29.8%, P = .260) at 3 years compared with no ETF.

Conclusions: ETF occurred in 16% of patients with CLTI and was associated with multilevel occlusions and proximal SFA occlusion. ETF was due to inability to cross the lesion in 82%. It did not impact long-term above-ankle amputation or death but was associated with increased major revascularization.