Background: Although aggressive endoluminal therapy for superficial femoral artery (SFA) occlusive disease is commonplace, the implications of diabetes mellitus (DM) on long-term outcomes in this population are unclear. We examined the consequences of endovascular treatment of the SFA in patients with and without DM.
Methods: A database of patients undergoing endovascular treatment of the SFA between 1986 and 2005 was maintained. Three groups were defined: nondiabetic patients, those with non-insulin-dependent DM (NIDDM), and those with insulin-dependent DM (IDDM). Intention-to-treat analysis was performed. Results were standardized to TransAtlantic Inter-Society Consensus (TASC) and Society for Vascular Surgery criteria. Time-dependent outcomes were assessed with Kaplan-Meier survival analyses. Factor analyses were performed using a Cox proportional hazard model for time-dependent variables. Data are presented as mean +/- SD where appropriate.
Results: Endovascular treatment (ie, balloon angioplasty +/- adjuvant stenting in 38%) was initiated in 525 limbs in 437 patients (68% male; average age, 66 +/- 14 years) for claudication failing conservative therapy or chronic critical limb ischemia (CLI). Of these, 50% were nondiabetic, 26% had NIDDM, and 24% had IDDM. Analyses were separated by those presenting with claudication (61%) and those presenting with CLI (39%). Among patients presenting with claudication, those with IDDM had significantly lower assisted primary patency (P < .01) and a higher incidence of restenosis (P = .04). Patencies at 3 years for nondiabetic, NIDDM, and IDDM were 62%, 72%, and 54% (primary), and 81%, 86%, and 65% (assisted primary), respectively. Patency and restenosis rates were associated with lesion calcification, TASC D lesion categorization, and acute periprocedural occlusion. Among patients presenting with CLI, patency and restenosis rates were equivalent across all groups; however, limb salvage was significantly worse for both groups of diabetic patients compared with nondiabetic (NIDDM, P = .01; IDDM, P = .02). Reduction in limb salvage rates was associated with presence of tissue loss at presentation, end-stage renal disease, and progression of distal disease on follow-up.
Conclusions: Endoluminal therapy for SFA occlusive disease yields lower assisted patency rates and higher restenosis rates for those patients presenting with claudication who have more advanced diabetes (ie, IDDM). Among those patients presenting with CLI, particularly those with tissue loss, limb salvage rates are lowered for the diabetic groups (NIDDM and IDDM) despite equivalent patency and restenosis rates.