Aftab Syed Arafat, Tay Kiang Hiong, Irani Farah G, Gong Lo Richard Hoau, Gogna Apoorva, Haaland Benjamin, Tan Seck Guan, Chng Siew Png, Pasupathy Shanker, Choong Hui Lin, Tan Bien Soo
Duke-National University of Singapore Graduate Medical School, Singapore.
Duke-National University of Singapore Graduate Medical School, Singapore; Department of Diagnostic Radiology, Singapore General Hospital, Singapore.
J Vasc Interv Radiol. 2014 Feb;25(2):190-8. doi: 10.1016/j.jvir.2013.10.020. Epub 2013 Dec 5.
To compare the efficacy and safety of cutting balloon angioplasty (CBA) versus high-pressure balloon angioplasty (HPBA) for the treatment of hemodialysis autogenous fistula stenoses resistant to conventional percutaneous transluminal angioplasty (PTA).
In a prospective, randomized clinical trial involving patients with dysfunctional, stenotic hemodialysis arteriovenous fistulas (AVFs), patients were randomized to receive CBA or HPBA if conventional PTA had suboptimal results (ie, residual stenosis > 30%). A total of 516 patients consented to participate in the study from October 2008 to September 2011, 85% of whom (n = 439) had technically successful conventional PTA. The remaining 71 patients (mean age, 60 y; 49 men) with suboptimal PTA results were eventually randomized: 36 to the CBA arm and 35 to the HPBA arm. Primary and secondary target lesion patencies were determined by Kaplan-Meier analysis.
Clinical success rates were 100% in both arms. Primary target lesion patency rates at 6 months were 66.4% and 39.9% for CBA and HPBA, respectively (P = .01). Secondary target lesion patency rates at 6 months were 96.5% for CBA and 80.0% for HPBA (P = .03). There was a single major complication of venous perforation following CBA. The 30-day mortality rate was 1.4%, with one non-procedure-related death in the HPBA group.
Primary and secondary target lesion patency rates of CBA were statistically superior to those of HPBA following suboptimal conventional PTA. For AVF stenoses resistant to conventional PTA, CBA may be a better second-line treatment given its superior patency rates.
比较切割球囊血管成形术（CBA）与高压球囊血管成形术（HPBA）治疗对传统经皮腔内血管成形术（PTA）耐药的血液透析自体动静脉内瘘狭窄的疗效和安全性。
在一项前瞻性随机临床试验中，纳入患有功能障碍性、狭窄性血液透析动静脉内瘘（AVF）的患者，若传统PTA效果欠佳（即残余狭窄>30%），则将患者随机分为接受CBA或HPBA治疗。2008年10月至2011年9月，共有516例患者同意参与本研究，其中85%（n = 439）的患者传统PTA技术成功。其余71例（平均年龄60岁；49例男性）PTA效果欠佳的患者最终被随机分组：36例进入CBA组，35例进入HPBA组。采用Kaplan-Meier分析确定主要和次要靶病变通畅率。
两组的临床成功率均为100%。CBA组和HPBA组6个月时主要靶病变通畅率分别为66.4%和39.9%（P = 0.01）。CBA组和HPBA组6个月时次要靶病变通畅率分别为96.5%和80.0%（P = 0.03）。CBA术后发生1例静脉穿孔的严重并发症。30天死亡率为1.4%，HPBA组有1例与手术无关的死亡。
在传统PTA效果欠佳后，CBA的主要和次要靶病变通畅率在统计学上优于HPBA。对于对传统PTA耐药的AVF狭窄，CBA的通畅率更高，可能是更好的二线治疗方法。
