Woong Gil Choi, Seung-Woon Rha, Byoung Geol Choi, Soohyung Park, Ji Bak Kim, Dong Oh Kang, Cheol Ung Choi, Yong Sung Seo, Yoon Hyung Cho, Sang Ho Park, Seung Jin Lee, Young Guk Ko, Ae-Young Her, Sang Min Kim, Ki Chang Kim, Jang Hyun Cho, Won Yu Kang, Joo Han Kim, Min Woong Kim, Do Hoi Kim, Jang Ho Bae, Ji Hoon Ahn, Sang Cheol Jo, Jae Bin Seo, Woo Young Jung, Sang Min Park
{"title":"动脉粥样硬化性髂动脉疾病球囊扩张型钴铬支架与自扩张型镍钛诺支架对比试验(SENS-ILIAC 试验):随机对照试验。","authors":"Woong Gil Choi, Seung-Woon Rha, Byoung Geol Choi, Soohyung Park, Ji Bak Kim, Dong Oh Kang, Cheol Ung Choi, Yong Sung Seo, Yoon Hyung Cho, Sang Ho Park, Seung Jin Lee, Young Guk Ko, Ae-Young Her, Sang Min Kim, Ki Chang Kim, Jang Hyun Cho, Won Yu Kang, Joo Han Kim, Min Woong Kim, Do Hoi Kim, Jang Ho Bae, Ji Hoon Ahn, Sang Cheol Jo, Jae Bin Seo, Woo Young Jung, Sang Min Park","doi":"10.1007/s00380-024-02431-4","DOIUrl":null,"url":null,"abstract":"<p><p>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).</p>","PeriodicalId":12940,"journal":{"name":"Heart and Vessels","volume":" ","pages":"1060-1067"},"PeriodicalIF":1.4000,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Balloon-expandable cobalt chromium stent versus self-expandable nitinol stent for the Atherosclerotic Iliac Arterial Disease (SENS-ILIAC Trial) Trial: a randomized controlled trial.\",\"authors\":\"Woong Gil Choi, Seung-Woon Rha, Byoung Geol Choi, Soohyung Park, Ji Bak Kim, Dong Oh Kang, Cheol Ung Choi, Yong Sung Seo, Yoon Hyung Cho, Sang Ho Park, Seung Jin Lee, Young Guk Ko, Ae-Young Her, Sang Min Kim, Ki Chang Kim, Jang Hyun Cho, Won Yu Kang, Joo Han Kim, Min Woong Kim, Do Hoi Kim, Jang Ho Bae, Ji Hoon Ahn, Sang Cheol Jo, Jae Bin Seo, Woo Young Jung, Sang Min Park\",\"doi\":\"10.1007/s00380-024-02431-4\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>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).</p>\",\"PeriodicalId\":12940,\"journal\":{\"name\":\"Heart and Vessels\",\"volume\":\" \",\"pages\":\"1060-1067\"},\"PeriodicalIF\":1.4000,\"publicationDate\":\"2024-12-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Heart and Vessels\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s00380-024-02431-4\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/7/2 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Heart and Vessels","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s00380-024-02431-4","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/7/2 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
Balloon-expandable cobalt chromium stent versus self-expandable nitinol stent for the Atherosclerotic Iliac Arterial Disease (SENS-ILIAC Trial) Trial: a randomized controlled trial.
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).
期刊介绍:
Heart and Vessels is an English-language journal that provides a forum of original ideas, excellent methods, and fascinating techniques on cardiovascular disease fields. All papers submitted for publication are evaluated only with regard to scientific quality and relevance to the heart and vessels. Contributions from those engaged in practical medicine, as well as from those involved in basic research, are welcomed.