Clinical and Angiographic Outcome After Interventional Treatment of the Iliac Arteries with a New CarboFilm™ Coated Stent: Preliminary Results

Abstract

To evaluate the handling, the procedural success rate and the six-month outcome of a new Carbofilm coated balloon-expandable stent in iliac artery lesions. In a prospective study, 46 stenoses and 2 occlusions of the iliac arteries were primarily stented in 30 patients with the Isthmus CarboStent (Sorin Biomedica Cardio S.p. A., Saluggia, Italy). The ankle-brachial index (ABI) at rest was determined before intervention and at the six-month follow-up visit. Iliac angiography, including intraarterial pressure measurement, was performed before intervention, post-procedurally and at the follow-up visit. All lesions were treated with procedural success. The mean degree of all stenoses was 73.9 % +/- 14.6 before and 2.4 % +/- 8.2 after intervention. The mean pressure gradient was 15.6 mm Hg +/- 10.1 before and 2.5 mm Hg +/- 2.7 after treatment. No or only a mild restenosis developed in 27 patients. The mean ABI increased from 0.64 +/- 0.21 to 0.86 +/- 0.33 and the mean pressure gradient was 2.7 mm Hg +/- 5.4 at the six-month visit. The six-month patency rate was 97.9 %. Three patients showed acute stent thrombosis due to an insufficient postprocedural antiplatelet regimen. The Isthmus CarboStent is a safe and easy to handle balloon-expandable stent for interventional therapy of iliac artery lesions. The six-month patency rate is good. Despite its Carbofilm coating, postprocedural antiplatelet therapy is necessary.