Outcomes of polytetrafluoroethylene-covered stent versus bare-metal stent in the primary treatment of severe iliac artery obstructive lesions

Abstract

This study compared early and midterm outcomes of polytetrafluoroethylene-covered stents (CSs) vs bare-metal stents (BMSs) in the primary treatment of severe TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) C and D iliac artery obstructive lesions. Between January 2009 and June 2014, 128 patients underwent stenting of 167 iliac arteries; CSs were implanted in 82 iliac arteries (49%) and BMSs in 85 (51%). All patients were prospectively enrolled in a dedicated database. Thirty-day outcomes, mid-term patency, limb salvage, and survival were compared, and follow-up results were analyzed with Kaplan-Meier curves. Clinical presentation, lesion site, extension, and laterality were evaluated for their association with patency in the two groups using multiple logistic regressions. Patients were a mean age of 70± 10.3years, The Society for Vascular Surgery comorbidity score was 0.89± 0.57, with no differences after stratification by CS and BMS (P= .17). Iliac lesions were classified by limb as TASC II C in 86 (51%) and D in 81 (49%). Comparing CS and BMS, technical success was 99% in both groups (P= 1.0); the 30-day cumulative surgical complications rate (7.3% vs 4.7%; P= .53), mortality (1.8% vs 0%; P= .45), and morbidity (1.8% vs 1.4%; P= .99) were equivalent. At 24months (average 22months; range, 30 days-56 months), primary patency of CS vs BMS was similar (93% vs 80%; P= .14), and this finding was maintained after stratification by TASC II C (97% vs 93%; P= .59) and D (88% vs 61%; P= .07); secondary patency was 98% vs 92% (P= .22), and limb salvage was 99% and 95% (P= .35) respectively. Multivariate analysis indicated that BMS in long-segment stenosis involving the common and external iliac arteries was a negative predictor of patency (odds ratio, 0.16; 95% confidence interval, 0.04-0.62; P= .007); within this subgroup of TASC II D lesions, primary patency at 24months was significantly higher for CS than for BMS (88% vs 57%; P= .03). Overall, the use of CSs for severe iliac lesions has similar early and midterm outcomes compared with BMS. In a subcategory of TASC II D lesions with long-segment severe stenosis of both the common and external iliac arteries, CS should be considered as the primary line of treatment.