%0 Journal Article
%T Balloon-expandable cobalt chromium stent versus self-expandable nitinol stent for the Atherosclerotic Iliac Arterial Disease (SENS-ILIAC Trial) Trial: a randomized controlled trial.
%A Choi WG
%A Rha SW
%A Choi BG
%A Park S
%A Kim JB
%A Kang DO
%A Choi CU
%A Seo YS
%A Cho YH
%A Park SH
%A Lee SJ
%A Ko YG
%A Her AY
%A Kim SM
%A Kim KC
%A Cho JH
%A Kang WY
%A Kim JH
%A Kim MW
%A Kim DH
%A Bae JH
%A Ahn JH
%A Jo SC
%A Seo JB
%A Jung WY
%A Park SM
%A  
%J Heart Vessels
%V 0
%N 0
%D 2024 Jul 2
%M 38953938
%F 1.814
%R 10.1007/s00380-024-02431-4
%X Iliac artery angioplasty with stenting is an effective alternative treatment modality for aortoiliac occlusive diseases. Few randomized controlled trials have compared the efficacy and safety between self-expandable stent (SES) and balloon-expandable stent (BES) in atherosclerotic iliac artery disease. In this randomized, multicenter study, patients with common or external iliac artery occlusive disease were randomly assigned in a 1:1 ratio to either BES or SES. The primary end point was the 1-year clinical patency, defined as freedom from any surgical or percutaneous intervention due to restenosis of the target lesion after the index procedure. The secondary end point was a composite event from major adverse clinical events at 1 year. A total of 201 patients were enrolled from 17 major cardiovascular intervention centers in South Korea. The mean age of the enrolled patients was 66.8 ± 8.5 years and 86.2% of the participants were male. The frequency of critical limb ischemia was 15.4%, and the most common target lesion was in the common iliac artery (75.1%). As the primary end point, the 1-year clinical patency as primary end point was 99% in the BES group and 99% in the SES group (p > 0.99). The rate of repeat revascularization at 1 year was 7.8% in the BES group and 7.0% in the SES group (p = 0.985; confidence interval, 1.011 [0.341-2.995]). In our randomized study, the treatment of iliac artery occlusive disease with self-expandable versus balloon-expandable stent was comparable in 12-month clinical outcomes without differences in the procedural success or geographic miss rate regardless of the deployment method in the distal aortoiliac occlusive lesion (ClinicalTrials.gov, NCT01834495).