Relationship Between Primary Patency and Lesion Length Following Bare Nitinol Stent Placement for Femoropopliteal Disease

Abstract

Purpose: To evaluate the relationship between 1-year primary patency and lesion length in patients with femoropopliteal disease treated with bare nitinol stents. Methods: The study was a retrospective analysis of a prospectively maintained multicenter database. Between January 2004 and December 2011, 1047 consecutive patients (mean age 72 years; 765 men) underwent femoropopliteal stenting with nitinol stents in 1373 limbs. The mean vessel diameter was 5.3±0.7 mm and the mean lesion length was 142±75 mm. One-year follow-up data were collected and analyzed to ascertain which lesion length would be expected to demonstrate a 1-year primary patency above the established 66% objective performance goal (OPG). Results: The lower limit of the 95% confidence interval (CI) for the unadjusted 1-year primary patency was >66% when the lesion length was ≤243 mm. After adjustment of the covariates to match those of the OPG-derived population, the 1-year primary patency decreased linearly with longer lesion length. The 1-year primary patency was 83.2% (95% CI 79.8% to 86.1%) for a 100-mm lesion length, 76.4% (95% CI 71.7% to 80.5%) for a 200-mm lesion length, and 70.7% (95% CI 62.4% to 77.7%) for a 300-mm lesion length. The maximum lesion length providing a 1-year primary patency significantly greater than 66% was calculated to be 263 mm. Conclusion: The 1-year primary patency of femoropopliteal lesions treated with bare nitinol stents decreased linearly with longer lesion length. The maximum lesion length providing a higher patency rate than the OPG of 66% was ~25 cm.