COMPARISON OF WALLGRAFT(TM) AND WALLSTENT(R) FOR TREATMENT OF COMPLEXILIAC ARTERY-STENOSIS AND OCCLUSION - PRELIMINARY-RESULTS OF A PROSPECTIVE RANDOMIZED STUDY

We performed a prospective randomized study to compare the use of a ba re metal stent (WALLSTENT(R) Endoprosthesis) with use of a covered ste nt (WALLGRAFT(TM) Endoprosthesis)-both made by Schneider; Inc.; Minnea polis, Minn-for the treatment of complex iliac artery stenosis and occ lusion. We report the preliminary results of a study performed at our institution from 1 February 1997 through 31 April 1997. The patient gr oup was composed of 6 women and 4 men, with a mean age of 61.8 years ( range, 47 to 73 years). Six WALLGRAFT endoprostheses (4 in the left il iac artery and 2 in the right) and 9 WALLSTENT endoprostheses (5 in th e left iliac artery and 4 in the right! were implanted. The mean perce nt stenosis before treatment was similar in both groups (84.17% in the WALLGRAFT group and 82.14% in the WALLSTENT group). The post-treatmen t stenosis and peak systolic gradients were negligible or zero in both groups. The devices were safely deployed and technical success (<30% residual stenosis) was achieved in both groups. The mean thigh-brachia l index was similar in the 2 groups, both before treatment (0.65 in th e WALLGRAFT group and 0.64 in the WALLSTENT group) and after treatment (1.12 in the WALLGRAFT group and 1.12 in the WALLSTENT group). Evalua tion of clinical success revealed that symptoms of intermittent claudi cation improved markedly in 4 of 5 patients who received the WALLGRAFT Endoprosthesis. In the WALLSTENT group, 1 patient had symptomatic imp rovement, another had 1 limb improve and the other worsen, and the res t had no improvement. Clinical complications were observed in only I p atient in the WALLGRAFT group and in 2 patients in the WALLSTENT group . These preliminary results indicate very good technical and early suc cess at the 1-month follow-up with the use of the WALLGRAFT Endoprosth esis in complex iliac artery stenosis and occlusion. Despite these pro mising preliminary results, a longer follow-up study with a larger num ber of patients is needed to determine the benefits of the WALLGRAFT E ndoprosthesis in patients with complex iliac artery stenosis or occlus ion.