Intermediate Outcomes of Femoropopliteal Stenting in Women: 3-Year Results of the DURABILITY II Trial

Background This study investigated the effects of gender on the 3-year outcomes of the StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protege EverfLex NitInol STent System II (DURABILITY II) trial. Methods A total of 287 patients enrolled in the DURABILITY II trial (prospective and nonrandomized trial) were stratified by gender and evaluated for primary, primary assisted, and secondary patency at 3 years. Clinical scores including changes in ankle-brachial index (ABI) and walking impairment questionnaire (WIQ) scores were evaluated. Results Overall 190 male and 97 female patients were included for analysis. The 3-year primary, assisted primary, and secondary patency rates for women versus men were 62.5% vs. 58.8%, 68.5% vs. 64.9%, and 72.1% vs. 67.2%, respectively ( P P P  = 0.03). Women versus men had inferior walking distance scores at presentation (13.6 vs. 25.7, P P P Conclusions Women continue to see clinical improvement after intervention, achieving comparable ABIs and walking distance to men at 2 years. These benefits are diminished at 3-year follow-up with women achieving lower absolute ABI and WIQ parameters compared with men, but improved overall compared with scores at presentation.