Background: 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.
Methods: 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.
Results: 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.
Conclusions: 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.).
Copyright © 2020 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.