一项比较血液透析患者早期与标准动静脉内瘘置管的随机对照研究。
A randomized controlled study of early versus standard cannulation of arteriovenous grafts in hemodialysis patients.
机构信息
Department of Vascular Surgery, Faculty of Medicine, Zagazig University, Zagazig, Egypt.
Department of Vascular Surgery, Faculty of Medicine, Zagazig University, Zagazig, Egypt.
出版信息
J Vasc Surg. 2022 Mar;75(3):1047-1053. doi: 10.1016/j.jvs.2021.08.106. Epub 2021 Sep 30.
OBJECTIVE
Arteriovenous grafts (AVGs) are frequently needed in hemodialysis (HD) patients with unsuitable superficial veins. First cannulation of standard arteriovenous grafts (sAVGs) still require about 2 weeks after implantation. Early cannulation arteriovenous grafts (eAVGs) were suggested to overcome this shortcoming. The present randomized study proposed to compare the clinical outcomes of sAVGs and eAVGs in HD patients.
METHODS
The present single-center randomized clinical study recruited 477 HD patients indicated for AVG creation. They included 236 in the sAVG group and 241 in the eAVG group. Eligible patients were simply randomized and allocated to the studied groups using 1:1 allocation ratio. Blinding was secured using the sealed envelope technique. Enrolled patients were followed up for 12 months. The primary outcome in the present study was primary, primary assisted, and secondary patency rates at 12 months. Other outcome parameters included time to first cannulation, graft complications, and mortality.
RESULTS
Comparison between the studied groups regarding the primary outcomes revealed no statistically significant differences. Primary patency rate was 65.7% and 68.0% (P = .58) at 6 months and 53.8% and 56.4% (P = .57) at 12 months in the sAVG and eAVG groups, respectively. Primary assisted patency rate was 70.8% and 69.7% (P = .8) in patients with sAVG and eAVG, whereas the reported rates at 12 months were 59.3% and 61.0% (P = .71), respectively. Secondary patency rate was 78.4% and 73.9% (P = .25) at 6 months and 67.8% and 69.7% (P = .65) at 12 months in the sAVG and eAVG groups, respectively. As expected, patients in the eAVG group experienced significantly earlier cannulation when compared with patients in the sAVG group (median, 3.0 days; range, 1.0-9.0 days vs 19.0 days; range, 15.0-22.0 days; P < .001).
CONCLUSIONS
Patients in the eAVG group have comparable outcomes to those in the sAVG group at 12 months with the added advantage of earlier time to first cannulation.
目的
在不适合浅静脉的血液透析（HD）患者中，经常需要动静脉移植物（AVG）。标准动静脉移植物（sAVG）的首次插管仍需在植入后约 2 周进行。早期插管动静脉移植物（eAVG）被建议克服这一缺点。本随机研究旨在比较 HD 患者中 sAVG 和 eAVG 的临床结局。
方法
本单中心随机临床研究纳入了 477 例需要 AVG 治疗的 HD 患者。其中 sAVG 组 236 例，eAVG 组 241 例。符合条件的患者采用 1:1 分配比例简单随机分组。采用密封信封技术确保盲法。入组患者随访 12 个月。本研究的主要结局是 12 个月时的一级、一级辅助和二级通畅率。其他结局参数包括首次插管时间、移植物并发症和死亡率。
结果
两组患者的主要结局比较无统计学差异。sAVG 和 eAVG 组的一级通畅率分别为 65.7%和 68.0%（P=0.58），6 个月时为 53.8%和 56.4%（P=0.57），12 个月时为 53.8%和 56.4%（P=0.57）。sAVG 和 eAVG 组一级辅助通畅率分别为 70.8%和 69.7%（P=0.8），12 个月时分别为 59.3%和 61.0%（P=0.71）。sAVG 和 eAVG 组二级通畅率分别为 78.4%和 73.9%（P=0.25），6 个月时为 67.8%和 69.7%（P=0.65），12 个月时为 67.8%和 69.7%（P=0.65）。与 sAVG 组相比，eAVG 组患者的插管时间明显更早（中位数 3.0 天；范围 1.0-9.0 天比 19.0 天；范围 15.0-22.0 天；P<0.001）。
结论
eAVG 组患者在 12 个月时的结局与 sAVG 组相当，但首次插管时间更早。
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