Abstract
BACKGROUND: There are substantial data supporting the use of atherectomy for the treatment of coronary artery disease, but data regarding its efficacy for treating chronic limb-threatening ischemia (CLTI) are less robust. OBJECTIVES: The authors aimed to evaluate the association of atherectomy with limb-based outcomes among patients managed with endovascular revascularization in the BEST-CLI (Best Endovascular vs Best Surgical Therapy in Patients With CLTI; NCT02060630) trial. METHODS: BEST-CLI was a prospective randomized trial comparing open and endovascular revascularization strategies for patients with CLTI. We included all patients treated with endovascular revascularization and stratified them according to whether they were treated with or without atherectomy. We evaluated whether atherectomy was associated with major adverse limb events (MALE) (including major reintervention or above-ankle amputation in the index limb) and secondary outcomes using Kaplan-Meier analyses and Cox proportional hazards models. RESULTS: 923 patients underwent an endovascular intervention in the BEST-CLI trial (mean age 67.3 ± 10.0 years, 71.1%[656/923] male, 72.3%[662/916] White race), of which 132 (14.3%) received an atherectomy. After risk adjustment, MALE (adjusted HR [aHR]: 1.30; 95% CI: 0.92-1.84), major reintervention (aHR: 1.07; 95% CI: 0.67-1.73), above-ankle amputation (aHR: 1.32; 95% CI: 0.81-2.15), and all-cause death (aHR: 1.06; 95% CI: 0.75-1.49) were similar for patients who were treated with and without atherectomy. In a sensitivity analysis limited to patients with technical success, atherectomy was associated with higher MALE (unadjusted log-rank P = 0.02; aHR: 1.51; 95% CI: 1.03-2.22). CONCLUSIONS: Atherectomy was associated with similar or slightly worse limb-based outcomes among patients undergoing endovascular revascularization for CLTI compared with other available endovascular technologies.