Comparison of SFA lesion treatment with Zilver PTX in diabetics vs. non-diabetics: 2-year clinical and functional results.

Background: Prospective single-arm study, aimed at evaluating safety and effectiveness at 12 and 24 months of the paclitaxel-eluting nitinol stent (Zilver PTX), and focused in particular on the treatment of complex lesions and/or diabetic patients.
Methods: Between May 2010 and March 2012, 67 patients (78% males) were treated by Zilver PTX, because of stenosis or occlusions of the superficial femoral artery in one of two centers. The mean age of patients was 70.1±8 years. Thirty-two of 67 (48%) were diabetics, 14 (21%) active smokers and 11 (14.6%) had chronic renal failure (end stage renal disease). The average length of lesions was 104±60 mm. Occlusion was complete in 46.3% of cases, whereas severely calcified lesions were present in 30% of patients (18.8% in diabetics and 31.4% in non-diabetics). Twenty-six patients (39%) had type C or D lesions according to TASC 2.
Results: One hundred-two stents were used (1.7±0.9 per patients); median 1 (range 1-4). All patients had successful stent placement. Primary patency, evaluated by Kaplan-Meier method was 88±0.06% at 12 months, and 68±0.1% at 24 months. In particular, the difference between diabetics (D) and non-diabetics (non-D) was not significant (P=0.07, Log-Rank). Patients turned from 4.2±1.3 to 1.6±1.3 Rutherford class. There were 5 deaths due to systemic comorbidities. There also were 3 major amputations, all of them also in the D group. Among the other patients, differences between D and non-D patients were not significant in terms of wound healing, bipedal stay and spontaneous ambulation. The mean follow-up length was 28±5 months (range 24-36 months). There was only one patient who had fracture and stent migration (1.5%). In 13 diabetic patients, tibial PTA was also associated. Additional treatment was required in 6 D and 1 non-D.
Conclusions: The use of Zilver PTX is safe and effective in the treatment of SFA lesions. In particular, both stent patency and functional results on the basis of both clinical and instrumental tools were similar in D and non-D, suggesting a particularly favorable activity of PTX in a subpopulation of diabetics. Further studies are required to confirm these results, which seem to be particularly promising in diabetic patients.