Heindel Patrick, Fitzgibbon James J, Secemsky Eric A, Belkin Michael, Ozaki C Keith, Hussain Mohamad A
Department of Surgery, Division of Vascular and Endovascular Surgery, Brigham and Women's Hospital, Boston, MA 02115, United States.
Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Boston, MA 02115, United States.
Am J Epidemiol. 2025 Mar 4;194(3):651-658. doi: 10.1093/aje/kwae098.
Most of the 800 000 people living with end-stage kidney disease in the United States rely on a functioning vascular access to provide life-sustaining hemodialysis, yet one-third of arteriovenous fistulas experience early failures. Determining the safety and effectiveness of systemic heparin during fistula creation could improve the quality and quantity of life for these vulnerable patients. In this article, a pragmatic randomized trial was emulated to assess the effect of systemic heparin administration (vs none) during radiocephalic arteriovenous fistula creation on early bleeding and thrombosis, using data from 2 international, multicenter, randomized trials performed between 2014 and 2019. Marginal risks were estimated using inverse probability weighted parametric survival analysis and CIs were generated with bootstrapping. A total of 914 patients were enrolled and 61% received systemic heparin; their median (IQR) age was 58 (49, 67) years and 45% were on hemodialysis at enrollment. No difference in the risk of bleeding events was observed, with a risk difference (95% CI) at 14 days of -0.1% (-1.6 to 1.4). The risk of access thrombosis was lower in the heparin group, with a risk of 3.7% (2.6-4.8) after heparin and 5.3% (3.4-7.4) without heparin at 14 days (risk ratio = 0.72; 95% CI, 0.50-0.98). Trial registration: ClinicalTrials.gov. Identifiers: NCT02110901 and NCT02414841.
美国80万终末期肾病患者中的大多数依靠正常运作的血管通路来进行维持生命的血液透析，然而三分之一的动静脉内瘘会出现早期失败。确定在造瘘过程中使用全身肝素的安全性和有效性，可改善这些脆弱患者的生活质量和寿命。在本文中，我们模拟了一项实用随机试验，利用2014年至2019年期间开展的2项国际多中心随机试验的数据，评估在桡动脉-头静脉内瘘造瘘过程中给予全身肝素（与不给予相比）对早期出血和血栓形成的影响。使用逆概率加权参数生存分析估计边际风险，并通过自抽样法生成置信区间。共纳入914例患者，61%接受了全身肝素治疗；他们的年龄中位数（四分位间距）为58（49，67）岁，45%在入组时正在接受血液透析。未观察到出血事件风险存在差异，14天时的风险差异（95%置信区间）为-0.1%（-1.6至1.4）。肝素组的通路血栓形成风险较低，14天时肝素治疗后的风险为3.7%（2.6 - 4.8），未使用肝素时为5.3%（3.4 - 7.4）（风险比 = 0.72；95%置信区间，0.50 - 0.98）。试验注册：ClinicalTrials.gov。标识符：NCT02110901和NCT02414841。
