Division of Plastic Surgery, University of Utah, Salt Lake City, Utah.
Division of Plastic Surgery, University of Utah, Salt Lake City, Utah.
Ann Thorac Surg. 2020 Jun;109(6):1713-1721. doi: 10.1016/j.athoracsur.2019.12.058. Epub 2020 Feb 8.
Venous thromboembolism is an important patient safety issue in thoracic surgery patients. The optimal enoxaparin dose remains unclear. This multicenter pre/post clinical trial compared the pharmacokinetics of fixed versus weight-tiered enoxaparin, and their impact on 90-day venous thromboembolism and bleeding.
Thoracic surgery patients were prospectively enrolled using a pre/post study design. Cohort 1 received enoxaparin 40 mg daily, and cohort 2 received a weight-tiered regimen: less than 70 kg received 30 mg daily; 70 kg to 89.9 kg received 40 mg once daily; and 90 kg or more received 50 mg daily. The primary study outcome was peak anti-factor Xa levels in response to fixed or weight-tiered enoxaparin. Secondary outcomes included trough anti-factor Xa, 90-day symptomatic venous thromboembolism, and 90-day clinically relevant bleeding.
One hundred thirty-one patients were prospectively enrolled, including 65 in the fixed-dose cohort and 66 in the weight-tiered cohort. No patient was lost to follow-up. Weight-tiered enoxaparin was not significantly more likely to produce adequate anticoagulation (peak anti-factor Xa 0.3 IU/mL or greater) when compared with fixed-dose enoxaparin (44.3% vs 48.2%, P = .67). Weight-tiered enoxaparin was not more likely to avoid over-anticoagulation (peak anti-factor Xa 0.5 IU/mL or greater) when compared with fixed-dose enoxaparin (3.3% vs 3.6%, P = 1.00). The groups had no significant difference in trough anti-factor Xa. Observed rates of 90-day symptomatic venous thromboembolism and clinically relevant bleeding were low (0% and 3.1%, respectively) and were not significantly different between groups.
This multicenter pre/post clinical trial did not show a pharmacokinetic advantage to weight-tiered enoxaparin, when compared with fixed-dose enoxaparin, in thoracic surgery patients. (Clinicaltrials.gov identifier: NCT03251963.).
静脉血栓栓塞症是胸外科患者的一个重要的患者安全问题。最佳依诺肝素剂量仍不清楚。这项多中心的前后临床研究比较了固定剂量与体重分层依诺肝素的药代动力学，并比较了它们对 90 天静脉血栓栓塞和出血的影响。
采用前后研究设计前瞻性纳入胸外科患者。队列 1 每天接受依诺肝素 40mg，队列 2 接受体重分层方案：体重＜70kg 者每天接受 30mg；体重 70kg 至 89.9kg 者每天接受 40mg；体重≥90kg 者每天接受 50mg。主要研究结局是固定剂量或体重分层依诺肝素的峰值抗因子 Xa 水平。次要结局包括谷值抗因子 Xa、90 天有症状静脉血栓栓塞和 90 天临床相关出血。
共前瞻性纳入 131 例患者，其中固定剂量组 65 例，体重分层组 66 例，无患者失访。与固定剂量依诺肝素相比，体重分层依诺肝素并未显著提高充分抗凝（峰值抗因子 Xa≥0.3IU/ml）的可能性（44.3% vs.48.2%，P=0.67）。与固定剂量依诺肝素相比，体重分层依诺肝素也没有更可能避免过度抗凝（峰值抗因子 Xa≥0.5IU/ml）（3.3% vs.3.6%，P=1.00）。两组间谷值抗因子 Xa 无显著差异。90 天有症状静脉血栓栓塞和临床相关出血的发生率较低（分别为 0%和 3.1%），两组间无显著差异。
与固定剂量依诺肝素相比，这项多中心的前后临床研究在胸外科患者中并未显示体重分层依诺肝素具有药代动力学优势。（临床试验注册号：NCT03251963）。
