Healio
Healio
January 04, 2012
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Enoxaparin failed to reduce mortality in acutely ill patients

Kakkar A. N Engl J Med. 2011;365:2463-2472.

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The use of enoxaparin in addition to graduated compression stockings for thromboprophylaxis did not improve 30-day all-cause mortality among hospitalized, acutely ill patients, according to results from the LIFENOX trial.

In the double blind, placebo-controlled study, researchers randomly assigned 8,307 acutely ill patients (mean age, 65 years; 37.3% women) to receive a daily 40-mg subcutaneous injection of enoxaparin (Lovenox, Sanofi-Aventis) or placebo for 10 ± 4 days. Both groups were also assigned to wear elastic stockings with graduated compression. Patients were aged at least 40 years and qualified for inclusion if they were hospitalized for one of three reasons:

  • Acute decompensated HF.
  • Severe systemic infection with at least one risk factor for venous thromboembolism.
  • Active cancer.

After 30 days, all-cause mortality was similar between groups. The rate of death from any cause was 4.9% in the enoxaparin group and 4.8% in the placebo group (RR=1; 95% CI, 0.8-1.2). Study results showed that pulmonary failure was the most common cause of death by day 30, which occurred in 2.1% of patients in the enoxaparin arm and 1.8% of patients in the placebo arm. Multivariate analyses also identified the following as significant predictors for 30-day mortality:

  • Active cancer (OR=4; 95% CI, 2.8-5.8).
  • Chronic pulmonary disease (OR=1.3; 95% CI, 1.1-1.7).
  • Two or more acute illnesses (OR=1.6; 95% CI, 1.2-2.3).
  • Renal impairment (OR=2; 95% CI, 1.6-2.4).

    • No significant differences were noted in 90-day mortality between groups.

    Researchers found major bleeding rates of 0.4% in the enoxaparin arm and 0.3% in the placebo arm during and up to 48 hours after the treatment period (RR=1.4; 95% CI, 0.7-3.1). In the enoxaparin group, the rate of all adverse events was 37.8%. Similarly, this rate was 36.9% in the placebo group. Further, the rates of serious adverse events and adverse events leading to death were comparable between groups. However, according to study results, the rate of adverse events that led to permanent discontinuation of the study drug was higher in the enoxaparin group vs. the placebo group (3.6% vs. 2.8%).

    Since the natural history of deep vein thrombosis is well established in surgical patients, physicians assume that it would also be well established in acutely ill medical patients, this assumption may be incorrect, and perhaps the natural history of deep-vein thrombosis differs between medical and surgical patients, according to the researchers.

    “[The study] findings appear to be counterintuitive given the fact that pharmacologic prophylaxis has been shown to reduce the risk of VTE, including asymptomatic deep-vein thrombosis, by at least 45% in hospitalized, acutely ill medical patients,” the researchers concluded.

    Disclosure: The LIFENOX trial was supported by Sanofi-Aventis. Various researchers report involvement in various companies.

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