Atherectomy-assisted endovascular therapy versus open repair for atherosclerotic common femoral artery disease: The multicenter ARISTON study.

Abstract

Background: Endarterectomy (open repair) represents the gold-standard for common femoral atherosclerotic disease (CFAD) treatment. However, with developments like atherectomy, endovascular therapy (endovascular revascularization) may offer an alternative option. The aim of the present study was to evaluate the safety and effectiveness of endovascular versus open therapy for the CFAD.

Methods: The ARISTON (AtheRectomy-assIsted endovaScular Therapy versus OpeN) study was an 11-center research collaborative in which data from consecutive patients with symptomatic CFAD were analyzed. Retrospective matching was performed for patient-specific characteristics, including age, cardiovascular risk factors and comorbidities, and lesion-specific variables, including lesion calcification and complexity. Primary endpoints were all-cause mortality and freedom from clinically driven target lesion revascularization (CD-TLR). Amputation-free survival (AFS) was a secondary endpoint.

Results: From 2015 to 2022, 826 patients undergoing endovascular (n = 213 [25.8%]) versus open therapy (n = 613 [74.2%]) were analyzed. The total number of procedural complications was higher with open therapy, whereas hospital stay was shorter with endovascular therapy (p < 0.0001 for both). Major adverse cardiac and limb events at 30-day outcomes were, however, not statistically different (p = 0.06). Bail-out stent rates with atherectomy-assisted endovascular therapy were 5.1%. After matching and during 1.72 (0.9-3.3) years of follow up, all-cause mortality, AFS, and CD-TLR were not statistically different in endovascular versus open therapy (HR = 0.68, 95% CI 0.36-1.29; HR = 1.5, 95% CI 0.59-3.77; and HR = 1.46, 95% CI 0.61-3.49, p = NS for all).

Conclusion: Endovascular and open therapy exhibit comparable outcomes for the treatment of patients with symptomatic CFAD, including similar CD-TLR in patients with claudication and AFS in patients with critical limb-threatening ischemia, during short-term follow up. Atherectomy-assisted endovascular therapy may therefore provide a useful alternative for patients who are unfit for surgery.