Weight-adjusted enoxaparin thromboprophylaxis was feasible and well-tolerated with no major hemorrhages, while fixed-dose enoxaparin was associated with a 22% cumulative incidence of DVT.
RCT (n=50)
Double-blind
randomly assigned
Yes
Does weight-adjusted enoxaparin improve safety and prevent VTE compared to fixed-dose enoxaparin in hospitalized high-risk cancer patients?
Weight-adjusted enoxaparin is feasible and well-tolerated for VTE prophylaxis in high-risk hospitalized cancer patients, who demonstrate a high incidence of asymptomatic VTE on standard fixed-dose therapy.
Hospitalized patients with cancer are at an increased risk of developing venous thromboembolism (VTE). The recommendation for routine pharmacologic thromboprophylaxis in hospitalized patients with cancer to prevent VTE is based on extrapolation of results from noncancer cohorts. There are limited data to support the efficacy and safety of fixed-dose low-molecular-weight heparin (LMWH) regimens in high-risk hospitalized patients with cancer. We conducted a randomized, double-blinded, phase 2 trial in hospitalized patients with active cancer at high risk of developing VTE based on Padua risk score. Patients were randomly assigned to fixed-dose enoxaparin (40 mg daily) vs weight-adjusted enoxaparin (1 mg/kg daily) during hospitalization. The primary objectives were to evaluate the safety of dose-adjusted enoxaparin and evaluate the incidence of VTE with fixed-dose enoxaparin. Blinded clinical assessments were performed at day 14, and patients randomly assigned to fixed-dose enoxaparin subsequently underwent a bilateral lower extremity ultrasound. A total of 50 patients were enrolled and randomized. The median weight of patients enrolled in weight-adjusted enoxaparin arm was 76 kg (range, 60.9-124.5 kg). There were no major hemorrhages or symptomatic VTE in either arm. At time of completion of the blinded clinical assessment, there was only 1 incidentally identified pulmonary embolus that occurred in the weight-adjusted arm. In the group randomly assigned to fixed-dose enoxaparin who subsequently underwent surveillance ultrasound, the cumulative incidence of DVT was 22% (90% binomial confidence interval, 0%-51.3%). This phase 2 trial confirms a high incidence of asymptomatic VTE among high-risk hospitalized patients with cancer and that weight-adjusted LMWH thromboprophylaxis is feasible and well-tolerated. This trial was registered at www.clinicaltrials.gov as #NCT02706249.
Zwicker et al. (Fri,) conducted a rct in active cancer at high risk of developing VTE (n=50). weight-adjusted enoxaparin vs. fixed-dose enoxaparin (40 mg daily) was evaluated on safety of dose-adjusted enoxaparin and incidence of VTE with fixed-dose enoxaparin (95% CI 0%-51.3%). Weight-adjusted enoxaparin thromboprophylaxis was feasible and well-tolerated with no major hemorrhages, while fixed-dose enoxaparin was associated with a 22% cumulative incidence of DVT.