Yuhao Lin, Yaowen Chang, Jing Wang, Huijun Yuan, Feng Zhang, Ruipeng Zhang, Jianjun Quan, Jian Dong, Yang Han, Longlong Cong, Lin Yang
{"title":"Twenty-Four-Month Outcomes of Heparin-Bonded Covered Stents and Drug-Coated Balloon Angioplasty in Femoropopliteal Artery Occlusion.","authors":"Yuhao Lin, Yaowen Chang, Jing Wang, Huijun Yuan, Feng Zhang, Ruipeng Zhang, Jianjun Quan, Jian Dong, Yang Han, Longlong Cong, Lin Yang","doi":"10.1161/JAHA.124.039384","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The clinical outcomes of comparing covered stents (CSs) and drug-coated balloons (DCBs) angioplasty in femoropopliteal artery occlusion remain unknown. This study aimed to evaluate the midterm efficacy of CS and DCB procedures in patients with FPO.</p><p><strong>Methods: </strong>All 194 patients were divided into CS (94 patients) and DCB (100 patients) groups in this multicenter retrospective study. The primary end point was primary patency at 24 months, and the secondary end points included freedom from clinically driven target lesion revascularization, limb salvage, major adverse events, and overall survival rates. Propensity score matching analysis was performed to reconfirm the main end points.</p><p><strong>Results: </strong>Compared with the patients in the DCB group, those in the CS group had a lower prevalence of smoking (54.3% versus 74.0%, <i>P</i>=0.004) and diabetes (38.3% versus 66.0%, <i>P</i><0.001) before propensity score matching. Compared with the DCB procedure, the CS procedure resulted in a significantly greater primary patency at 24 months (74.4% versus 55.8%, <i>P</i>=0.019), with comparable primary patency at 12 months; similar results were obtained after matching. However, there was no difference in terms of clinically driven target lesion revascularization, limb salvage, major adverse events, or overall survival rates. Subgroup analyses confirmed the superior clinical patency of CS in patients with diabetes (<i>P</i>=0.010) and proximal reference vessel diameter ≥5.0 mm (<i>P</i>=0.038). A baseline ankle brachial index <0.40 was likely to be an independent risk factor for restenosis, and a postprocedural ankle brachial index ≥0.80 and the CS used (hazard ratio [HR], 0.54 [95% CI, 0.32-0.91], <i>P</i>=0.021) were potential protective factors for restenosis after multivariate analysis.</p><p><strong>Conclusions: </strong>Compared with the DCB procedure, the CS procedure resulted in greater primary patency at 24 months in complicated femoropopliteal artery occlusion lesions.</p>","PeriodicalId":54370,"journal":{"name":"Journal of the American Heart Association","volume":" ","pages":"e039384"},"PeriodicalIF":5.0000,"publicationDate":"2025-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of the American Heart Association","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1161/JAHA.124.039384","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
Abstract
Background: The clinical outcomes of comparing covered stents (CSs) and drug-coated balloons (DCBs) angioplasty in femoropopliteal artery occlusion remain unknown. This study aimed to evaluate the midterm efficacy of CS and DCB procedures in patients with FPO.
Methods: All 194 patients were divided into CS (94 patients) and DCB (100 patients) groups in this multicenter retrospective study. The primary end point was primary patency at 24 months, and the secondary end points included freedom from clinically driven target lesion revascularization, limb salvage, major adverse events, and overall survival rates. Propensity score matching analysis was performed to reconfirm the main end points.
Results: Compared with the patients in the DCB group, those in the CS group had a lower prevalence of smoking (54.3% versus 74.0%, P=0.004) and diabetes (38.3% versus 66.0%, P<0.001) before propensity score matching. Compared with the DCB procedure, the CS procedure resulted in a significantly greater primary patency at 24 months (74.4% versus 55.8%, P=0.019), with comparable primary patency at 12 months; similar results were obtained after matching. However, there was no difference in terms of clinically driven target lesion revascularization, limb salvage, major adverse events, or overall survival rates. Subgroup analyses confirmed the superior clinical patency of CS in patients with diabetes (P=0.010) and proximal reference vessel diameter ≥5.0 mm (P=0.038). A baseline ankle brachial index <0.40 was likely to be an independent risk factor for restenosis, and a postprocedural ankle brachial index ≥0.80 and the CS used (hazard ratio [HR], 0.54 [95% CI, 0.32-0.91], P=0.021) were potential protective factors for restenosis after multivariate analysis.
Conclusions: Compared with the DCB procedure, the CS procedure resulted in greater primary patency at 24 months in complicated femoropopliteal artery occlusion lesions.
背景:覆盖支架(CSs)和药物包被球囊(DCBs)血管成形术治疗股腘动脉闭塞的临床效果尚不清楚。本研究旨在评估CS和DCB手术对FPO患者的中期疗效。方法:采用多中心回顾性研究,将194例患者分为CS组(94例)和DCB组(100例)。主要终点是24个月时的原发性通畅,次要终点包括无临床驱动的靶病变血运重建、肢体保留、主要不良事件和总生存率。进行倾向评分匹配分析以再次确认主要终点。结果:与DCB组患者相比,CS组患者的吸烟率(54.3%比74.0%,P=0.004)和糖尿病患病率(38.3%比66.0%,PP=0.019)较低,12个月时的原发性通畅率相当;匹配后得到了相似的结果。然而,在临床驱动的靶病变血运重建、肢体保留、主要不良事件或总生存率方面没有差异。亚组分析证实糖尿病患者CS临床通畅(P=0.010),近端参考血管直径≥5.0 mm (P=0.038)。多因素分析显示,基线踝肱指数(P=0.021)是再狭窄的潜在保护因素。结论:与DCB手术相比,CS手术在复杂股腘动脉闭塞病变24个月时可获得更大的原发性通畅。
期刊介绍:
As an Open Access journal, JAHA - Journal of the American Heart Association is rapidly and freely available, accelerating the translation of strong science into effective practice.
JAHA is an authoritative, peer-reviewed Open Access journal focusing on cardiovascular and cerebrovascular disease. JAHA provides a global forum for basic and clinical research and timely reviews on cardiovascular disease and stroke. As an Open Access journal, its content is free on publication to read, download, and share, accelerating the translation of strong science into effective practice.