Study Reports Long-Term Outcomes of Infrapopliteal DES Placement for CLI in Diabetic Patients

October 22, 2015—Findings from a study conducted 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) were published by Stavros Spiliopoulos, MD, et al in the Journal of Vascular and Interventional Radiology (2015;26:1423–1430).

The investigators concluded that infrapopliteal DES placement for the management of CLI in diabetic patients resulted in a 5-year survival rate of 55.5%, a 90.4% amputation-free survival (AFS) rate 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.

The investigators performed a retrospective analysis 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 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.

As summarized in JVIR, 214 patients with CLI (168 men [78.5%]; mean age, 70 ± 9 years) 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% at 1, 5, and 10 years, respectively. Target limb repeat intervention-free survival rates were 79.7%, 55.2%, and 49.7% at 1, 5, and 10 years, respectively. 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%), reported the investigators in JVIR.