Kitrou Panagiotis M, Katsanos Konstantinos, Spiliopoulos Stavros, Karnabatidis Dimitris, Siablis Dimitris
Department of Interventional Radiology, Patras University Hospital, School of Medicine, Rion 26504, Greece.
Department of Interventional Radiology, Guy's and St. Thomas' Hospitals, NHS Foundation Trust, King's Health Partners, London SE1 7EH, United Kingdom.
Eur J Radiol. 2015 Mar;84(3):418-423. doi: 10.1016/j.ejrad.2014.11.037. Epub 2014 Dec 15.
To report the final results and cost-effectiveness analysis of a prospective randomized controlled trial investigating drug-eluting balloon (DEB) versus plain balloon angioplasty (BA) for the treatment of failing dialysis access (NCT01174472).
40 patients were randomized to angioplasty with either DEB (n=20) or BA (n=20) for treatment of significant venous stenosis causing a failing dialysis access. Both arteriovenous fistulas (AVF) and synthetic arteriovenous grafts (AVG) were included. Angiographic follow up was scheduled every two months. Primary endpoints were technical success and target lesion primary patency at 1 year. Cumulative and survival analysis was performed. Incremental net benefit (INB) and incremental cost effectiveness ratio (ICER) were calculated and the cost-effectiveness acceptability curve (CEAC) was drawn.
Baseline variables were equally distributed between the two groups. At 1 year, cumulative target lesion primary patency was significantly higher after DEB application (35% vs. 5% after BA, p<0.001). Overall, median primary patency was 0.64 years in case of DEB vs. 0.36 years in case of BA (p=0.0007; unadjusted HR=0.27 [95%CI: 0.13-0.58]; Cox adjusted HR=0.23 [95%CI: 0.10-0.50]). ICER was 2198 Euros (€) per primary patency year of dialysis access gained. INB was 1068€ (95%CI: 31-2105€) for a willingness-to-pay (WTP) threshold of 5000€ (corresponding acceptability probability >97%).
DEB angioplasty may be a cost-effective option that significantly improves patency after angioplasty of venous stenoses of failing vascular dialysis access. Further large-scale randomized trials are warranted.
报告一项前瞻性随机对照试验的最终结果及成本效益分析，该试验旨在研究药物洗脱球囊（DEB）与普通球囊血管成形术（BA）治疗失功透析通路的效果（NCT01174472）。
40例患者被随机分为接受DEB血管成形术（n = 20）或BA血管成形术（n = 20），以治疗导致透析通路失功的严重静脉狭窄。动静脉内瘘（AVF）和人工动静脉移植物（AVG）均纳入研究。每两个月安排一次血管造影随访。主要终点为1年时的技术成功率和靶病变原发性通畅率。进行累积和生存分析。计算增量净效益（INB）和增量成本效益比（ICER），并绘制成本效益可接受性曲线（CEAC）。
两组间基线变量分布均衡。1年时，应用DEB后累积靶病变原发性通畅率显著更高（DEB组为35%，BA组为5%，p<0.001）。总体而言，DEB组的中位原发性通畅时间为0.64年，BA组为0.36年（p = 0.0007；未调整的风险比[HR]=0.27[95%置信区间（CI）：0.13 - 0.58]；Cox调整后的HR = 0.23[95%CI：0.10 - 0.50]）。获得每一年透析通路原发性通畅的ICER为2198欧元（€）。对于5000欧元的支付意愿（WTP）阈值，INB为1068€（95%CI：31 - 2105€）（相应的可接受概率>97%）。
DEB血管成形术可能是一种具有成本效益的选择，可显著提高失功血管透析通路静脉狭窄血管成形术后的通畅率。有必要进行进一步的大规模随机试验。
