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亚洲慢性肢体威胁性缺血患者使用依维莫司洗脱可吸收血管支架的早期和中期经验:来自DISAPEAR注册研究的一年临床和影像学结果

Early and Midterm Experience With the Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold in Asian Patients With Chronic Limb-Threatening Ischemia: One-Year Clinical and Imaging Outcomes From the DISAPEAR Registry.

作者信息

Kum Steven, Ipema Jetty, Chun-Yin Derek Ho, Lim Darryl M, Tan Yih Kai, Varcoe Ramon L, Hazenberg Constantijn E V B, Ünlü Çağdaş

机构信息

Vascular Service, Department of Surgery, Changi General Hospital, Singapore.

Department of Vascular Surgery, Northwest Clinics, Alkmaar, the Netherlands.

出版信息

J Endovasc Ther. 2020 Aug;27(4):616-622. doi: 10.1177/1526602820922524. Epub 2020 May 29.

Abstract

To report an experience with the Absorb bioresorbable vascular scaffold (BVS) in an Asian cohort with chronic limb-threatening ischemia (CLTI) from the DISAPEAR (rug mpregnated Bioresorbable tent in sian opulation xtremity rterial evascularization) registry. A retrospective analysis was conducted of 41 patients (median age 64 years; 23 men) with CLTI owing to >50% de novo infrapopliteal lesions (n=53) treated with the Absorb BVS between August 2012 and June 2017. The majority of patients (37, 90%) had diabetes, 24 (59%) had ischemic heart disease, and 39 (95%) had Rutherford category 5/6 ischemia with tissue loss. The mean lesion length was 22.7±17.2 mm; 10 (24%) lesions were severely calcified. Assessments included technical success, primary patency, freedom from clinically-driven target lesion revascularization (CD-TLR), amputation-free survival, limb salvage, complete wound healing, resolution of rest pain, and resolution of CLTI without TLR at 6 and 12 months after the index intervention. Overall, 69 scaffolds were implanted in the 53 lesions, with 100% technical success. There were no deaths within 30 days of the index procedure. The primary patency rates at 6 and 12 months were 95% and 86%, respectively. The corresponding rates of freedom from CD-TLR were 98% and 93%, respectively. Freedom from major amputation was 98% at both time points, and amputation-free survival was 93% and 85% at 6 and 12 months after the index procedure. Wound healing occurred in 31 patients (79%) with Rutherford category 5/6 ischemia by the end of 12 months. The Absorb BVS demonstrated good 1-year patency and clinical outcomes in CLTI patients with complex infrapopliteal disease.

摘要

报告来自DISAPEAR(亚洲人群下肢动脉血运重建中可吸收生物可吸收血管支架)注册研究的亚洲慢性肢体威胁性缺血(CLTI)队列中使用Absorb生物可吸收血管支架(BVS)的经验。对2012年8月至2017年6月期间因新发腘下病变>50%(n = 53)而接受Absorb BVS治疗的41例CLTI患者(中位年龄64岁;23例男性)进行回顾性分析。大多数患者(37例,90%)患有糖尿病,24例(59%)患有缺血性心脏病,39例(95%)患有Rutherford 5/6级缺血伴组织缺失。平均病变长度为22.7±17.2毫米;10例(24%)病变严重钙化。评估包括技术成功率、原发性通畅率、免于临床驱动的靶病变血运重建(CD-TLR)、无截肢生存率、肢体挽救、完全伤口愈合、静息痛缓解以及在索引干预后6个月和12个月时无TLR的CLTI缓解情况。总体而言,在53个病变中植入了69个支架,技术成功率为100%。索引手术30天内无死亡病例。6个月和12个月时的原发性通畅率分别为95%和86%。相应的免于CD-TLR的比率分别为98%和93%。两个时间点的免于大截肢率均为98%,索引手术后6个月和12个月时的无截肢生存率分别为93%和85%。到12个月末,31例(79%)Rutherford 5/6级缺血患者伤口愈合。Absorb BVS在患有复杂腘下疾病的CLTI患者中显示出良好的1年通畅率和临床结果。

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