{"title":"Clinical Comparison of Drug-Coated Balloon and Drug-Eluting Stent for Femoropopliteal Lesions in Chronic Limb-Threatening Ischemia With Wounds","authors":"Kenji Ogata, Kensaku Nishihira, Yuya Asano, Yasuhiro Honda, Keisuke Yamamoto, Hiroki Emori, Kosuke Kadooka, Toshiyuki Kimura, Takeaki Kudo, Keiichi Ashikaga, Yoshisato Shibata, Kenichi Tsujita","doi":"10.1253/circj.cj-24-0176","DOIUrl":null,"url":null,"abstract":"</p><p><b><i>Background:</i></b> Endovascular therapy (EVT) with devices such as drug-coated balloons (DCBs) and drug-eluting stents (DESs) for atherosclerotic disease in the femoropopliteal (FP) artery has been established. However, EVT using drug-based devices for chronic limb-threatening ischemia (CLTI) remains challenging. The optimal device for FP lesions in patients with CLTI remains unknown. This study compared the clinical efficacy of DCB and DES in patients with CLTI and FP lesions.</p><p><b><i>Methods and Results:</i></b> This retrospective single-center study included 539 consecutive patients (562 lesions) treated with EVT between January 2018 and December 2022; 166 patients with CLTI and Rutherford Class 5 or 6 wounds underwent EVT with DCB or DES. Clinical outcomes were compared between 53 pairs after propensity score matching. There were no significant differences between the DCB and DES groups in the incidence of complete wound healing without death or major amputation (84.8% vs. 80.2%, respectively; P=0.99), primary patency (69.4% vs. 75.6%, respectively; P=0.65), and freedom from target lesion revascularization at 1 year (78.6% vs. 78.0%, respectively; P=0.92). Multivariate analysis showed that complete wound healing at 1 year is negatively associated with hemodialysis and Wound, Ischemia, and foot Infection Stage 4, but positively associated with Global Limb Anatomic Staging System FP Grade 3 or 4.</p><p><b><i>Conclusions:</i></b> No significant differences in clinical outcomes were found between DCB and DES for patients with CLTI and FP lesions.</p>\n<p></p>","PeriodicalId":50691,"journal":{"name":"Circulation Journal","volume":null,"pages":null},"PeriodicalIF":3.1000,"publicationDate":"2024-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Circulation Journal","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1253/circj.cj-24-0176","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Endovascular therapy (EVT) with devices such as drug-coated balloons (DCBs) and drug-eluting stents (DESs) for atherosclerotic disease in the femoropopliteal (FP) artery has been established. However, EVT using drug-based devices for chronic limb-threatening ischemia (CLTI) remains challenging. The optimal device for FP lesions in patients with CLTI remains unknown. This study compared the clinical efficacy of DCB and DES in patients with CLTI and FP lesions.
Methods and Results: This retrospective single-center study included 539 consecutive patients (562 lesions) treated with EVT between January 2018 and December 2022; 166 patients with CLTI and Rutherford Class 5 or 6 wounds underwent EVT with DCB or DES. Clinical outcomes were compared between 53 pairs after propensity score matching. There were no significant differences between the DCB and DES groups in the incidence of complete wound healing without death or major amputation (84.8% vs. 80.2%, respectively; P=0.99), primary patency (69.4% vs. 75.6%, respectively; P=0.65), and freedom from target lesion revascularization at 1 year (78.6% vs. 78.0%, respectively; P=0.92). Multivariate analysis showed that complete wound healing at 1 year is negatively associated with hemodialysis and Wound, Ischemia, and foot Infection Stage 4, but positively associated with Global Limb Anatomic Staging System FP Grade 3 or 4.
Conclusions: No significant differences in clinical outcomes were found between DCB and DES for patients with CLTI and FP lesions.
背景:使用药物涂层球囊(DCB)和药物洗脱支架(DES)等设备对股腘动脉(FP)动脉粥样硬化性疾病进行血管内治疗(EVT)的方法已经确立。然而,使用基于药物的设备对慢性肢体缺血(CLTI)进行EVT仍然具有挑战性。针对慢性肢体缺血患者股腘动脉病变的最佳装置仍是未知数。本研究比较了DCB和DES在CLTI和FP病变患者中的临床疗效:这项回顾性单中心研究纳入了2018年1月至2022年12月期间接受EVT治疗的539例连续患者(562个病变);166例CLTI和Rutherford 5级或6级伤口患者接受了DCB或DES的EVT治疗。经过倾向评分匹配后,53对患者的临床结果进行了比较。DCB组和DES组在伤口完全愈合且无死亡或重大截肢的发生率(分别为84.8% vs. 80.2%;P=0.99)、初次通畅率(分别为69.4% vs. 75.6%;P=0.65)和1年后无靶病变血管再通的发生率(分别为78.6% vs. 78.0%;P=0.92)方面无明显差异。多变量分析显示,1年后伤口完全愈合与血液透析及伤口、缺血和足部感染4期呈负相关,但与全球肢体解剖分期系统FP 3级或4级呈正相关:在CLTI和FP病变患者中,DCB和DES的临床结果无明显差异。
期刊介绍:
Circulation publishes original research manuscripts, review articles, and other content related to cardiovascular health and disease, including observational studies, clinical trials, epidemiology, health services and outcomes studies, and advances in basic and translational research.