Atherectomy with Angioplasty versus Angioplasty Alone for Critical Limb-Threatening Ischemia with Isolated Tibial Disease

BACKGROUND: Critical limb-threatening ischemia (CLTI) causes significant morbidity and mortality worldwide. Although simple balloon angioplasty has been around for decades, the use of atherectomy devices for CLTI treatment has expanded exponentially in recent years. There remains a gap in research on the comparative outcomes of adjunct atherectomy versus stand-alone angioplasty in patients with critical limb ischemia, particularly for patients with isolated tibial disease. METHODS: Using TriNetX Data Network, a global federated database of over 250 million patients, we conducted a retrospective cohort study of CLTI patients who underwent tibial atherectomy versus balloon angioplasty alone, up to July 2024. Patients younger than 18 years or with a history of prior or concomitant vascular intervention, including open and endovascular procedures, were excluded. Eligible patients were 1:1 propensity score-matched for preoperative covariates, including demographics and comorbidities. Three-month, 12-month, and 5-year outcomes of mortality, major and minor amputations, and reintervention were calculated and compared between the 2 cohorts using odds ratios (ORs) and hazard ratios (HRs) with 95% confidence intervals (CIs). RESULTS: This study identified 752 patients who underwent atherectomy-assisted angioplasty and 3,195 who underwent angioplasty alone. A total of 749 patients in each cohort were matched to compare outcomes spanning 5 years. In total, 72.1% were male, 63.7% White, and the mean age was 66.5 ± 12.3 (Table 1). The mean follow-up period was 687 days for the atherectomy group and 744 days for the angioplasty group. Three-month outcomes resulted in comparable OR for mortality (OR [95% CI] = 1.13 [0.73-1.74]), major amputation (OR [95% CI] = 1.08 [0.77-1.51]), and reintervention (OR [95% CI] = 1.06 [0.81-1.40]). However, atherectomy was associated with significantly fewer minor amputations (OR [95% CI] = 0.74 [0.57-0.96]). The same trend continued out to 5 years, with comparable mortality and reintervention rates and significantly fewer minor amputations (23.4% vs. 30.0%, OR [95% CI] = 0.71 [0.56-0.89]) in the atherectomy group. Notably, major amputation was also significantly lower in the atherectomy group at 5 years compared to the balloon angioplasty group (14.6% vs. 18.4%, OR [95% CI] = 0.75 [0.57-0.99]). HRs for major amputation at 3 months, 12 months, and 5 years were close to 1, with the 5-year HR at 0.816. CONCLUSION: This study suggests a potential clinical advantage of atherectomy for first-time revascularization in patients with critical limb ischemia and isolated tibial disease. The reductions in adverse outcomes suggest atherectomy offers long-term clinical benefits over angioplasty alone, warranting further investigation.