Results of a European multicentre iliac stent trial with a flexible balloon expandable stent

PURPOSE: to determine the 12 months success rate with a balloon expandable, flexible stainless steel stent in iliac artery obstructions. MATERIALS AND METHODS: one-hundred and twenty-six consecutive patients with iliac obstructive disease and who demonstrated an unsatisfactory angioplasty result with a post-dilatation gradient of at least 10 mmHg, or a primary occluded lesion were included in the study. Follow-up was by Doppler sonography, ankle pressures with and without exercise and clinical parameters. RESULTS: after stent placement, the mean percentage diameter stenosis decreased from 79 to 4%, with a mean intra-arterial pressure gradient of 3 mmHg. Primary stent patency was 94% at 6 months and 89% at 12 months. Primary clinical result at 6 months was 88% and at 12 months 81%. Primary assisted clinical result (after re-pta) at 6 and 12 months was 89 and 86%, respectively. The Ankle Brachial Index (ABI) after exercise at 1 month follow-up was reduced from 0.88 to 0.75, with minor deterioration at 6 months to 0.72, and at 12 months to 0.68. The 1, 6, and 12 months follow-up Piek Systolic Velocity (PSV) ratios across the stented lesions remained stable at a mean of 1.4, 1.6, and 1.6, respectively. However, respectively 44, 39 and 34% of the patients still experienced symptoms of claudication. CONCLUSIONS: the results presented here support the suggestion stenting to be an effective device in the treatment of iliac artery obstructive disease. This study also, confirms other study results concerning haemodynamic patency after iliac stenting on the indication of a 10 mmHg pressure gradient after pta and the discrepancy between good haemodynamic patency and clinical result