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. 2018 Aug;106(2):404-411. doi: 10.1016/j.athoracsur.2018.02.085. Epub 2018 Apr 5.
Many patients undergoing thoracic surgical procedures have venous thromboembolism (VTE) events despite the receipt of chemical prophylaxis. Enoxaparin's pharmacologic impact can be quantified by using anti-Factor Xa (aFXa) levels. We hypothesized that enoxaparin 40 mg once daily would be inadequate for most inpatients undergoing thoracic surgical procedures and that a real-time dose adjustment algorithm would be effective.
This prospective clinical trial enrolled inpatients who were to undergo a thoracic surgical procedure and placed on enoxaparin 40 mg once daily for VTE prophylaxis after surgical procedures. aFXa levels were used to measure the anticoagulant effect of enoxaparin once steady state had been reached. Patients whose aFXa levels were out of range received real-time enoxaparin dose adjustment and had repeat aFXa levels drawn.
Ninety-three inpatients undergoing thoracic surgical procedures were prospectively enrolled. The majority of patients (67.4%) had low peak aFXa levels (<0.3 IU/mL), indicative of inadequate enoxaparin prophylaxis, and 30.3% of patients had in-range aFXa levels (0.3 to 0.5 IU/mL). Patient weight had a moderate correlation (r 0.38) with peak aFXa level. Patient weight, female sex, and preoperative creatinine were independent predictors of peak aFXa in a linear regression model. Real-time, protocol-driven enoxaparin dose adjustment allowed a significantly increased proportion of patients to achieve in-range aFXa levels (30.3% vs 97.6%, p < 0.001).
Enoxaparin 40 mg once daily is inadequate for most inpatients undergoing thoracic surgical procedures, based on a pharmacodynamic study of aFXa levels. Future research should examine the impact of weight-based once daily enoxaparin dosing versus twice daily enoxaparin dosing on prophylaxis adequacy.
许多接受胸外科手术的患者尽管接受了化学预防,但仍会发生静脉血栓栓塞(VTE)事件。依诺肝素的药效学影响可以通过抗因子 Xa(aFXa)水平来定量。我们假设,对于大多数接受胸外科手术的住院患者,依诺肝素 40mg 每日一次的剂量不足,并且实时剂量调整算法将是有效的。
本前瞻性临床试验纳入了将接受胸外科手术的住院患者,并在手术后每天接受依诺肝素 40mg 一次以预防 VTE。aFXa 水平用于测量依诺肝素达到稳态后的抗凝效果。aFXa 水平不在范围内的患者接受实时依诺肝素剂量调整,并重复进行 aFXa 水平检测。
93 名接受胸外科手术的住院患者被前瞻性纳入研究。大多数患者(67.4%)的峰值 aFXa 水平较低(<0.3IU/mL),表明依诺肝素预防不足,而 30.3%的患者的 aFXa 水平在范围内(0.3 至 0.5IU/mL)。患者体重与峰值 aFXa 水平呈中度相关(r=0.38)。线性回归模型显示,患者体重、女性性别和术前肌酐是峰值 aFXa 的独立预测因素。实时、基于方案的依诺肝素剂量调整使更多的患者能够达到 aFXa 水平在范围内(30.3%比 97.6%,p<0.001)。
基于 aFXa 水平的药效学研究,依诺肝素 40mg 每日一次对大多数接受胸外科手术的住院患者是不足够的。未来的研究应探讨基于体重的每日一次依诺肝素给药与每日两次依诺肝素给药对预防效果的影响。