A randomized trial of vonapanitase (PATENCY-1) to promote radiocephalic fistula patency and use for hemodialysis
A randomized trial of vonapanitase (PATENCY-1) to promote radiocephalic fistula patency and use for hemodialysis
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DOI：
10.1016/j.jvs.2018.04.068
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发表时间：
2019-02-01
影响因子：
4.3
通讯作者：
Burke, Steven K.
中科院分区：
文献类型：
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作者：
Bleyer, Anthony J.;Scavo, Vincent A.;Burke, Steven K.
目的：慢性肾脏疾病患者所致的动静脉瘘常常失去通畅性，无法使用。这项前瞻性试验评估了vonapanitase，一种重组人弹性蛋白酶，在促进放射性头瘘开放和用于血液透析方面的效果。方法：Patency-1是一项双盲、安慰剂对照试验，纳入349名正在进行血液透析或即将进行血液透析的患者，并对放射头动静脉内瘘的建立进行评估。在这些患者中，313人被随机分配，311人接受治疗。患者被分配到vonapanitase组(n=210)或安慰剂组(n=103)。在瘘管形成后，立即将研究药物溶液局部应用于动脉和静脉10分钟。主要和次要终点是一次再通(首次血栓形成或矫正手术的时间)和二次再通(放弃时间)。结果：Kaplan-Meier估计的12个月主要通畅率为42%(95%可信区间，35-49)和31%(95%可信区间，21-42)(P=.25)。Kaplan-Meier对vonapanitase和安慰剂12个月继发通畅率的估计分别为74%(95%CI，68-80)和61%(95%CI，51-71)(P=.048)。Vonapanitase和安慰剂在非辅助透析患者中的比例分别为39%和25%(P=0.035)，在非辅助加辅助透析患者中分别为%和44%(P=0.006)。结论：Vonapanitase治疗不能显著改善一次通畅率，但与增加二次通畅率和用于血液透析有关。需要进一步的研究来评估这些终点。
Objective: Arteriovenous fistulas created in patients with chronic kidney disease often lose patency and fail to become usable. This prospective trial evaluated the efficacy of vonapanitase, a recombinant human elastase, in promoting radiocephalic fistula patency and use for hemodialysis.Methods: PATENCY-1 was a double-blind, placebo-controlled trial that enrolled 349 patients on or approaching hemodialysis and being evaluated for radiocephalic arteriovenous fistula creation. Of these, 313 were randomized and 311 treated. Patients were assigned to vonapanitase (n = 210) or placebo (n = 103). The study drug solution was applied topically to the artery and vein for 10 minutes immediately after fistula creation. The primary and secondary end points were primary patency (time to first thrombosis or corrective procedure) and secondary patency (time to abandonment). Tertiary end points included use of the fistula for hemodialysis, fistula maturation by ultrasound, and procedure rates.Results: The Kaplan-Meier estimates of 12-month primary patency were 42% (95% confidence interval [CI], 35-49) and 31% (95% CI, 21-42) for vonapanitase and placebo (P =.25). The Kaplan-Meier estimates of 12-month secondary patency were 74% (95% CI, 68-80) and 61% (95% CI, 51-71) for vonapanitase and placebo (P =.048). The proportions of vonapanitase and placebo patients were 39% and 25% (P =.035) with unassisted use for hemodialysis and 64% and 44% (P =.006) with unassisted plus assisted use.Conclusions: Vonapanitase treatment did not significantly improve primary patency but was associated with increased secondary patency and use for hemodialysis. Further research is needed to evaluate these end points.