Long-Term Clinical Outcomes of Infrapopliteal Drug-Eluting Stent Placement for Critical Limb Ischemia in Diabetic Patients

Purpose: To evaluate long-term clinical outcomes of infrapopliteal drug-eluting stent (DES) placement in insulin-dependent and non-insulin-dependent diabetic patients with critical limb ischemia (CLI).

Materials and methods: A retrospective analysis was performed of all diabetic patients treated with infrapopliteal DES between January 2002 and September 2012. The study's primary outcome measures were patient survival and major amputation-free survival (AFS). Secondary outcome measures included technical success (defined as the creation of a straight line of blood flow to the foot arch with < 30%), identification of independent predictors of primary outcomes, infrapopliteal target limb repeat intervention-free survival, and procedure-related complications.

Results: In total, 214 patients with CLI (168 men [78.5%]; mean age, 70 y ± 9) in 311 limbs, 562 arteries, and 679 lesions were treated. According to Kaplan-Meier analysis, survival rates were 90.8%, 55.5%, and 36.2%, and AFS rates were 94.9%, 90.4%, and 90.4%, respectively, at 1, 5, and 10 years. Target limb repeat intervention-free survival rates were 79.7%, 55.2%, and 49.7%, respectively, at 1, 5, and 10 years. The overall technical success rate was 97.7%. Cox multivariate analysis demonstrated that procedural failure was the only independent predictor of decreased AFS (hazard ratio [HR], 61.3; 95% confidence interval [CI], 13.8-271.9), and statin use was associated with increased survival (HR, 0.55; 95% CI, 0.31-0.98). Coronary disease (HR, 1.9; 95% CI, 1.01-3.54), dialysis (HR, 2.2; 95% CI, 1.21-4.06), and duration of diabetes (HR, 1.5; 95% CI, 1.02-2.34) were identified as independent predictors of decreased survival. Major complications occurred in four of 479 procedures (0.8%).

Conclusions: Infrapopliteal DES placement for the management of CLI in diabetic patients resulted in a 55.5% 5-year survival rate, with a 90.4% AFS at 5 and 10 years and a 50.3% repeat intervention rate at 10 years. Technical failure was associated with reduced AFS, and statin intake was associated with increased survival.