藥物塗層球囊治療功能障礙性動靜脈瘻療效顯著
作者：
小柯機器人發布時間：2020/8/23 21:41:52
美國西奈山伊坎醫學院Robert A. Lookstein團隊研究了藥物塗層球囊治療功能障礙性透析動靜脈瘻的療效。2020年8月20日，該成果發表在《新英格蘭醫學雜誌》上。
對於功能障礙性血液透析動靜脈瘻，目前推薦的標準方法是經皮腔內血管成形術，但這種治療方法的長期效果不佳。抗再狹窄藥紫杉醇藥物塗層球囊可改善預後。
在這項前瞻性、單盲、1：1隨機試驗中，研究組在29個國際站點招募了330位患有先天性上肢動靜脈瘻新病變或再狹窄病變的參與者。成功進行高壓經皮腔內血管成形術後，將參與者隨機組，其中170位接受藥物塗層球囊治療，160位接受標準球囊治療。主要療效終點是靶病變的通暢性，定義為手術後6個月內沒有臨床靶病變血運重建或通路血栓形成。
手術後6個月，藥物塗層球囊組的參與者中有82.2%保持靶病變的通暢性，顯著高於標準球囊組（59.5%）。藥物塗層球囊組中30天內涉及動靜脈通路的嚴重不良事件發生率為4.2%，不亞於標準球囊組（4.4%）。敏感性分析證實了主要分析的結果。
研究結果表明，採用藥物塗層球囊血管成形術治療功能障礙性血液透析動靜脈瘻狹窄病變，術後6個月的療效並不遜於標準血管成形術，且未顯著增加30天內與通路相關的嚴重不良事件風險。
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