美国西奈山伊坎医学院Robert A. Lookstein团队研究了药物涂层球囊治疗功能障碍性透析动静脉瘘的疗效。2020年8月20日，该成果发表在《新英格兰医学杂志》上。

对于功能障碍性血液透析动静脉瘘，目前推荐的标准方法是经皮腔内血管成形术，但这种治疗方法的长期效果不佳。抗再狭窄药紫杉醇药物涂层球囊可改善预后。

在这项前瞻性、单盲、1：1随机试验中，研究组在29个国际站点招募了330位患有先天性上肢动静脉瘘新病变或再狭窄病变的参与者。成功进行高压经皮腔内血管成形术后，将参与者随机组，其中170位接受药物涂层球囊治疗，160位接受标准球囊治疗。主要疗效终点是靶病变的通畅性，定义为手术后6个月内没有临床靶病变血运重建或通路血栓形成。

手术后6个月，药物涂层球囊组的参与者中有82.2%保持靶病变的通畅性，显著高于标准球囊组（59.5%）。药物涂层球囊组中30天内涉及动静脉通路的严重不良事件发生率为4.2%，不亚于标准球囊组（4.4%）。敏感性分析证实了主要分析的结果。

研究结果表明，采用药物涂层球囊血管成形术治疗功能障碍性血液透析动静脉瘘狭窄病变，术后6个月的疗效并不逊于标准血管成形术，且未显著增加30天内与通路相关的严重不良事件风险。

附：英文原文

Title: Drug-Coated Balloons for Dysfunctional Dialysis Arteriovenous Fistulas

Author: Robert A. Lookstein, M.D., M.H.C.D.L.,, Hiroaki Haruguchi, M.D.,, Kenneth Ouriel, M.D., M.B.A.,, Ido Weinberg, M.D.,, Lanyu Lei, Ph.D.,, Stephanie Cihlar, B.S.,, and Andrew Holden, M.B., Ch.B.

Issue&Volume: 2020-08-19

Abstract: Abstract

Background

Standard percutaneous transluminal angioplasty is the current recommended treatment for dysfunctional hemodialysis fistulas, yet long-term outcomes of this treatment are poor. Drug-coated balloons delivering the antirestenotic agent paclitaxel may improve outcomes.

Methods

In this prospective, single-blinded, 1:1 randomized trial, we enrolled 330 participants at 29 international sites. Patients with new or restenotic lesions in native upper-extremity arteriovenous fistulas were eligible for participation. After successful high-pressure percutaneous transluminal angioplasty, participants were randomly assigned to receive treatment with a drug-coated balloon or a standard balloon. The primary effectiveness end point was target-lesion primary patency, defined as freedom from clinically driven target-lesion revascularization or access-circuit thrombosis during the 6 months after the index procedure. The primary safety end point, serious adverse events involving the arteriovenous access circuit within 30 days, was assessed in a noninferiority analysis (margin of noninferiority, 7.5 percentage points). The primary analyses included all participants with available end-point data. Additional sensitivity analyses were performed to assess the effect of missing data.

Results

A total of 330 participants underwent randomization; 170 were assigned to receive treatment with a drug-coated balloon, and 160 were assigned to receive treatment with a standard balloon. During the 6 months after the index procedure, target-lesion primary patency was maintained more often in participants who had been treated with a drug-coated balloon than in those who had been treated with a standard balloon (82.2% [125 of 152] vs. 59.5% [88 of 148]; difference in risk, 22.8 percentage points; 95% confidence interval [CI], 12.8 to 32.8; P<0.001). Drug-coated balloons were noninferior to standard balloons with respect to the primary safety end point (4.2% [7 of 166] and 4.4% [7 of 158], respectively; difference in risk, 0.2 percentage points; 95% CI, 5.5 to 5.0; P=0.002 for noninferiority). Sensitivity analyses confirmed the results of the primary analyses.

Conclusions

Drug-coated balloon angioplasty was superior to standard angioplasty for the treatment of stenotic lesions in dysfunctional hemodialysis arteriovenous fistulas during the 6 months after the procedure and was noninferior with respect to access circuit–related serious adverse events within 30 days.

DOI: 10.1056/NEJMoa1914617

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1914617