Major Adverse Limb Events and Death After Successful Endovascular Revascularization: BEST-CLI Trial

Background Chronic limb-threatening ischemia (CLTI) has a high risk of limb amputation without revascularization. In the Best Surgical Therapy in CLTI (BEST-CLI) trial, endovascular revascularization had a higher risk of major adverse limb events (MALE) or death compared with surgical bypass with a good quality vein. However, endovascular revascularization is still required for patients with poor vein options or high surgical risk. We assessed the factors related to MALE or death among patients with a successful endovascular intervention in the BEST-CLI trial. Methods All patients with successful endovascular revascularization in the BEST-CLI trial were followed for a mean of 2.7 years. Baseline patient characteristics, lesion characteristics, and endovascular techniques were compared with the subsequent risk of MALE or death. Multivariable models estimated hazard ratios (HRs) and 95% CIs from Cox proportional hazards models. Results Of the 923 patients having endovascular revascularization, 773 (84%) had a successful index procedure. In femoral-popliteal interventions, MALE or death was associated with end-stage renal disease (HR, 1.64; 95% CI, 1.17-2.29), wounds at or above the ankle (HR, 2.13; 95% CI, 1.38-3.29), and longer procedure time (HR, 1.15 per 120 minutes; 95% CI, 1.02-1.30). In below-knee popliteal-tibial interventions, MALE or death was associated with diabetes mellitus (HR, 1.69; 95% CI, 1.18-2.43), end-stage renal disease (HR, 1.80; 95% CI, 1.26-2.57), and longer procedure time (HR, 1.28 per 120 minutes; 95% CI, 1.11-1.47). Interventional technique, including drug-coated technologies, did not relate to MALE or death. Conclusions Patient factors were strongly related to MALE or death after successful endovascular revascularization for CLTIs. Endovascular techniques, including drug-coated balloons and stents, were not consistently related to MALE or death in this high-risk population of patients with CLTI, justifying their use when needed for complex disease.