The Incidence and Consequences of Endovascular Technical Failure in Patients with Chronic Limb Threatening Ischemia: Results from the BEST-CLI Trial.

Purpose: To analyze the causes and clinical impacts of endovascular technical failure (ETF) in the BEST-CLI trial, which compared endovascular therapy to bypass surgery in patients with chronic limb-threatening ischemia (CLTI) 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 no 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 +10 vs 67+10 yrs, p=.007), less frequently Hispanic, and had more complex infrainguinal arterial occlusive disease versus no ETF. ETF had more multilevel arterial occlusions involving a combination of both the superficial femoral/popliteal (SFA/pop) segments and tibial segments (52% vs 41%, p=.029) , 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 two weeks of ETF. ETF had a higher rate of MALE (81% vs 29%, p <.0001) but similar rates of above-ankle amputation (18.7% vs 16.0%, p=0.0.528) and all-cause death (38.6% vs 29.8%, p=0.260) at 3 years versus 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.