Pharmacological thromboprophylaxis has been shown to reduce the incidence of venous thromboembolism in both surgical- and acutely ill medical patients. In surgical patients, thromboprophylaxis has been shown to reduce the incidence of fatal pulmonary embolism and the rate of death from any cause. An associated reduction in the rate of death from any cause has not been shown however with the use of thromboprophylaxis in acutely ill medical patients.
The LIFENOX trial was conducted to assess the effect of subcutaneous enoxaparin (40 mg daily) as compared with placebo, administered for 10 ± 4 days in patients who were wearing elastic stockings with graduated compression, on the rate of death from any cause among hospitalised, acutely ill medical patients.
The study involved 8307 patients from sites in China, India, Korea, Malaysia, Mexico, the Philippines, and Tunisia, who were aged at least 40 years and hospitalised for acute decompensated heart failure, severe systemic infection with at least one risk factor for venous thromboembolism, or active cancer. A total of 4171 patients were randomised to receive enoxaparin plus elastic stockings with graduated compression and 4136 to placebo plus elastic stockings with graduated compression (n= 4136). The primary efficacy outcome was the rate of death from any cause at 30 days after randomisation. The primary safety outcome was the rate of major bleeding during and up to 48 hours after the treatment period.
According to the intention to treat analysis:
• The rate of death from any cause at day 30 was 4.9% in the enoxaparin group vs. 4.8% in the placebo group (risk ratio, 1.0; 95% CI, 0.8 to 1.2; p = 0.83).
• The rate of major bleeding was 0.4% in the enoxaparin group and 0.3% in the placebo group (1.4; 0.7 to 3.1; p = 0.35).
The researchers conclude from these findings that among hospitalised, acutely ill medical patients, the rate of death from any cause did not differ significantly between patients who assigned to enoxaparin in addition to elastic stockings with graduated compression and those assigned to elastic stockings with graduated compression alone. However they reiterate that pharmacological thromboprophylaxis continues to have proven benefits in preventing venous thromboembolism, a condition which can lead to nonfatal complications such as the post-thrombotic syndrome and chronic thromboembolic pulmonary hypertension, which are often not treated successfully.