PREDICTORS OF PRIMARY PATENCY FAILURE IN WALLSTENT(R) SELF-EXPANDING ENDOVASCULAR PROSTHESES FOR ILIOFEMORAL OCCLUSIVE DISEASE

We studied the factors that affected the primary patency and the clini cal and procedural success of WALLSTENTS(R) (stents) that were used at our institution from 1 March 1994 To 30 October 1995 for the treatmen t of iliac and femoral artery occlusive disease. This prospective stud y comprised 63 patients with 82 lesions. Follow-up was performed for a mean duration of 18.7 months. Pre-and post-procedural duplex ultrason ography, together with estimation of ankle-brachial index scores, was performed on all patients, and additional studies were performed at cl inical follow-up if indicated. The technical success rate was 100%. An kle-brachial index scores improved considerably from 0.52 +/- 0.21 bef ore the procedure to 0.73 +/- 0.27 after the procedure. The significan t predictors by univariate analysis of primary patency failure were: F ontaine class ill or IV (P=0.044); femoral location (P=0.004); lesion length >100 mm (P=0.010); poor or moderate outflow (P=0.026); and numb er of stents greater than or equal to 3 (P=0.012). Cox regression anal ysis showed that greater than or equal to 3 stents (risk ratio=5.61), poor or moderate outflow (risk ratio=6.05), and femoral location (risk ratio=5.61 were the significant predictors of primary patency failure . Femoral lesions required more stents than did iliac lesions (2.2 +/- 10.8 vs 1.3 +/- 0.5). Primary patency rates for iliac and femoral ste nts were 86% and 49%, respectively at 12 months, and 82% and 41% at 24 months.