Balloon-expandable cobalt chromium stent versus self-expandable nitinol stent for the Atherosclerotic Iliac Arterial Disease (SENS-ILIAC Trial) Trial: a randomized controlled trial.

Autor: Choi WG; Regional Cardiovascular Disease Center, Chungbuk National University Hospital, Cheongju, Korea.; Department of Internal Medicine, College of Medicine, Chungbuk National University, Cheongju, Korea., Rha SW; Cardiovascular Center, Korea University Guro Hospital, 148, Gurodong-Ro, Guro-Gu, Seoul, 08308, Korea. swrha617@yahoo.co.kr., Choi BG; Cardiovascular Research Institute, Korea University, Seoul, Korea., Park S; Cardiovascular Center, Korea University Guro Hospital, 148, Gurodong-Ro, Guro-Gu, Seoul, 08308, Korea., Kim JB; Cardiovascular Center, Korea University Guro Hospital, 148, Gurodong-Ro, Guro-Gu, Seoul, 08308, Korea., Kang DO; Cardiovascular Center, Korea University Guro Hospital, 148, Gurodong-Ro, Guro-Gu, Seoul, 08308, Korea., Choi CU; Cardiovascular Center, Korea University Guro Hospital, 148, Gurodong-Ro, Guro-Gu, Seoul, 08308, Korea., Seo YS; Cardiovascular Center, Myongji Hospital, Goyang, Korea., Cho YH; Cardiovascular Center, Myongji Hospital, Goyang, Korea., Park SH; Department of Cardiology, Soonchunhyang University Cheonan Hospital, Cheonan, Korea., Lee SJ; Department of Cardiology, Soonchunhyang University Cheonan Hospital, Cheonan, Korea., Ko YG; Cardiovascular Center, Severance Hospital, Seoul, Korea., Her AY; Kangwon National University College of Medicine, Kangwon National University School of Medicine, Chuncheon, Korea., Kim SM; Regional Cardiovascular Disease Center, Chungbuk National University Hospital, Cheongju, Korea., Kim KC; Cardiovascular Center, Shiwha Medical Center, Siheung, Korea., Cho JH; Department of Cardiology, St. Carollo Hospital, Suncheon, Korea., Kang WY; Department of Cardiology, St. Carollo Hospital, Suncheon, Korea., Kim JH; Chunnam National University Hospital, Cardiovascular Center, Gwangju, Korea., Kim MW; Department of Cardiology, Hanyang University Medical Center Hanmaeum Hospital, Changwon, Korea., Kim DH; Cardiovascular Center, Soonchunhyang University Gumi Hospital, Gumi, Korea., Bae JH; Cardiovascular Center, Konyang University Hospital, Daejon, Korea., Ahn JH; Department of Cardiology, Eulji University Hospital, Deajeon, Korea., Jo SC; Gwangju Veterans General Hospital, Cardiovascular Center, Gwangju, Korea., Seo JB; Cardiovascular Center, Seoul University Boraemea Hospital, Seoul, Korea., Jung WY; Cardiovascular Center, Seoul University Boraemea Hospital, Seoul, Korea., Park SM; Department of Cardiology, Eulji General Hospital, Seoul, Korea.
Jazyk: angličtina
Zdroj: Heart and vessels [Heart Vessels] 2024 Dec; Vol. 39 (12), pp. 1060-1067. Date of Electronic Publication: 2024 Jul 02.
DOI: 10.1007/s00380-024-02431-4
Abstrakt: 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).
Competing Interests: Declarations Conflict of interest The authors declare no competing interests.
(© 2024. Springer Nature Japan KK, part of Springer Nature.)
Databáze: MEDLINE
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