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Atherectomy with Angioplasty vs. Angioplasty only for Critical Limb Ischemia with Isolated Tibial Disease
Emmanuel C Ebirim, Shalini Ramachandran, Junji Tsukagoshi, Mitchell Cox
The University of Texas Medical Branch, Galveston, TX
INTRODUCTION: Critical limb ischemia (CLI) causes significant morbidity and mortality worldwide and is a major focus for Vascular Surgery. While simple balloon angioplasty has been around for decades, the use of atherectomy devices for CLI treatment has expanded exponentially in recent years. This hasn’t been without controversy, as the costs to health systems are substantial, while benefits are less well-demonstrated. There remains limited research on the comparative outcomes of atherectomy versus stand-alone angioplasty in patients with critical limb ischemia.
METHODS: Using TriNetX Data Network, a global federated database of over 250 million patients, we conducted a retrospective cohort study of CLI patients up to July 2024 who underwent tibial atherectomy, versus balloon angioplasty alone. Patients >18 years, or with history of previous or concomitant vascular intervention, including open and endovascular, were excluded. Eligible patients were 1:1 propensity score-matched for preoperative co-variates including demographics and comorbidities. Three-month, twelve-month, and five-year outcomes of mortality, major and minor amputations, and reintervention amongst the two cohorts were calculated and compared using odds ratio (OR) with 95% confidence interval (CI).
RESULTS: This study identified 752 atherectomy and 3,195 balloon angioplasty patients. 749 patients in each cohort were matched to compare outcomes spanning 5 years. In total, 72.1% were male, 63.7% White, 28.2% Hispanic or Latino, 19.3% Black or African American, and 2% Asian with mean age at 66.5±12.3. Mean follow-up period was 687 and 744 days, respectively. 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, reintervention rate, and significantly fewer minor amputations (23.4% vs. 30.0%, OR [95% CI] = 0.71 [0.56-0.89]) with atherectomy. Notably, major amputation was also significantly lower in the atherectomy group at 5 years compared to balloon angioplasty group (14.6% vs. 18.4%, OR [95% CI] = 0.75 [0.57-0.99]).
CONCLUSIONS: Minor amputation rates were consistently lower amongst patients who underwent atherectomy versus angioplasty alone at all points from three to twelve months along with major amputation rates decreased at 5 years. Despite a number of limitations, this study suggests the possibility of real clinical advantage to using atherectomy for first-time revascularization in patients with critical limb ischemia with isolated tibial disease.
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