Peden Eric K, O'Connor Timothy P, Browne Barry J, Dixon Bradley S, Schanzer Andres S, Jensik Stephen C, Sam Albert D, Burke Steven K
Department of Cardiovascular Surgery, Houston Methodist Hospital, Houston, Tex.
Renal Care Associates, Peoria, Ill.
J Vasc Surg. 2017 Apr;65(4):1113-1120. doi: 10.1016/j.jvs.2016.08.101. Epub 2016 Dec 13.
This study explored the long-term outcomes of arteriovenous fistulas treated with vonapanitase (recombinant human elastase) at the time of surgical creation.
This was a randomized, double-blind, placebo-controlled trial of 151 patients undergoing radiocephalic or brachiocephalic arteriovenous fistula creation who were randomized equally to placebo, vonapanitase 10 μg, or vonapanitase 30 μg. The results after 1 year of follow-up were previously reported. The current analysis occurred when the last patient treated was observed for 3 years. For the current analysis, the primary end point was primary patency; the secondary end points included secondary patency, use of the fistula for hemodialysis, and rate of procedures to restore or to maintain patency.
There was no significant difference in the risk of primary patency loss with vonapanitase 10 μg or 30 μg vs placebo. When seven initial patency loss events related to cephalic arch and central vein balloon angioplasty were excluded, the risk of patency loss was reduced with vonapanitase overall (hazard ratio [HR], 0.63; P = .049) and 30 μg (HR, 0.51; P = .03). In patients with radiocephalic fistulas (n = 67), the risks of primary and secondary patency loss were reduced with 30 μg (HR, 0.37 [P = .02] and 0.24 [P = .046], respectively). The rate of procedures to restore or to maintain fistula patency was reduced with 30 μg vs placebo (0.23 vs 0.72 procedure days/patient/year; P = .03) and also reduced in patients with radiocephalic fistulas with 30 μg vs placebo (0.17 vs 0.85 procedure days/patient/year; P = .048).
In this study, vonapanitase did not significantly improve primary patency in the primary analysis but did significantly improve primary patency in an analysis that excluded patency loss due to cephalic arch and central vein balloon angioplasty. In patients with radiocephalic fistulas, 30 μg significantly improved primary and secondary patency. Vonapanitase 30 μg decreased the rate of procedures to restore or to maintain patency in the analysis that included all patients and in the subset with radiocephalic fistulas.
本研究探讨了在手术创建动静脉内瘘时使用vonapanitase（重组人弹性蛋白酶）的长期疗效。
这是一项随机、双盲、安慰剂对照试验，纳入了151例行桡动脉-头静脉或肱动脉-头静脉内瘘创建术的患者，他们被等分为安慰剂组、10μg vonapanitase组或30μg vonapanitase组。1年随访结果已先前报道。本次分析是在最后一名接受治疗的患者被观察3年后进行的。对于本次分析，主要终点是初始通畅率；次要终点包括次级通畅率、内瘘用于血液透析的情况以及恢复或维持通畅的操作率。
10μg或30μg vonapanitase组与安慰剂组相比，初始通畅率丧失风险无显著差异。当排除7例与头静脉弓和中心静脉球囊血管成形术相关的初始通畅率丧失事件后，总体上vonapanitase降低了通畅率丧失风险（风险比[HR]，0.63；P = 0.049），30μg vonapanitase组风险降低更显著（HR，0.51；P = 0.03）。在桡动脉-头静脉内瘘患者（n = 67）中，30μg vonapanitase降低了初始和次级通畅率丧失风险（分别为HR，0.37[P = 0.02]和0.24[P = 0.046]）。与安慰剂组相比，30μg vonapanitase降低了恢复或维持内瘘通畅的操作率（0.23 vs 0.72次操作/患者/年；P = 0.03），在桡动脉-头静脉内瘘患者中，30μg vonapanitase组与安慰剂组相比也降低了操作率（0.17 vs 0.85次操作/患者/年；P = 0.048）。
在本研究中，在初步分析中vonapanitase未显著改善初始通畅率，但在排除因头静脉弓和中心静脉球囊血管成形术导致的通畅率丧失的分析中显著改善了初始通畅率。在桡动脉-头静脉内瘘患者中，30μg vonapanitase显著改善了初始和次级通畅率。在纳入所有患者的分析以及桡动脉-头静脉内瘘亚组分析中，30μg vonapanitase降低了恢复或维持通畅的操作率。
