Department of Thoracic and Vascular Surgery, Skåne University Hospital, Malmö, Sweden.
Department of Clinical Sciences, Faculty of Medicine, Lund University, Malmö, Sweden.
J Int Med Res. 2022 Mar;50(3):3000605221081662. doi: 10.1177/03000605221081662.
To compare the efficacy of angioplasty using drug-eluting balloons (DEB) compared with plain old balloon angioplasty (POBA) to reduce the rate of restenosis.
This prospective, single-centre, single-blinded, 1:1 randomized, clinical trial enrolled patients that had primary or restenotic lesions in native upper extremity arteriovenous (AV) fistulas or at the graft-venous anastomosis. Patients were randomized to angioplasty with a POBA or a DEB. The primary effectiveness endpoints were freedom from target lesion revascularization (TLR) and functional status of access circuit at 12 months.
A total of 42 (28 male, 14 female; age range, 42-83 years) patients were enrolled. Patients were followed for 12 months. No significant differences were detected between the POBA and DEB groups regarding total number of TLR procedures (31 versus 36, respectively), freedom from TLR (3 versus 4, respectively) and functional status of the access circuit at 12 months (14 of 20 patients [70%] versus 17 of 22 patients [77%], respectively).
This clinical trial did not demonstrate any significant differences between DEB angioplasty and standard balloon angioplasty when treating dysfunctional haemodialysis access.
比较药物洗脱球囊（DEB）血管成形术与普通球囊血管成形术（POBA）降低再狭窄率的疗效。
这是一项前瞻性、单中心、单盲、1:1 随机、临床试验，纳入了原发性或复发性上肢动静脉（AV）瘘或移植物-静脉吻合口病变的患者。患者被随机分为 POBA 或 DEB 血管成形术组。主要有效性终点为 12 个月时无靶病变血运重建（TLR）和通路功能状态。
共纳入 42 例（28 例男性，14 例女性；年龄 42-83 岁）患者。患者随访 12 个月。POBA 组和 DEB 组在 TLR 总例数（分别为 31 例和 36 例）、TLR 无事件率（分别为 3 例和 4 例）和 12 个月时通路功能状态方面均无显著差异（20 例患者中有 14 例[70%]和 22 例患者中有 17 例[77%]）。
本临床试验未显示 DEB 血管成形术与标准球囊血管成形术治疗功能失调性血液透析通路时存在显著差异。
