Home > General Cardiology, Journal Club > Journal Club 18 April 2012

Journal Club 18 April 2012

Article:

Low-Molecular-Weight Heparin and Mortality in Acutely Ill Medical Patients

Presenter

NS

PICO

Double blinded placebo controlled randomized clinical trial (8307 patients)

Population

hospitalized, acutely ill medical patients at participating sites in China, India, Korea, Malaysia,Mexico, the Philippines, and Tunisia

Intervention

subcutaneous enoxaparin (40 mg daily) on top of standard care (including elastic stockings with graduated compression)

Comparator

Placebo on top of standard care (including elastic stockings with graduated compression)
There was significant discussion regarding thromboembolism prophylaxis in medical patients using enoxaparin.

Outcome

The primary efficacy outcome was the rate of death from any cause at 30 days
after randomization. The primary safety outcome was the rate of major bleeding
during and up to 48 hours after the treatment period.
Findings (from paper)

Results

A total of 8307 patients were randomly assigned to receive enoxaparin plus elastic
stockings with graduated compression (4171 patients) or placebo plus elastic stockings
with graduated compression (4136 patients) and were included in the intentionto-
treat population. The rate of death from any cause at day 30 was 4.9% in the
enoxaparin group as compared with 4.8% in the placebo group (risk ratio, 1.0; 95%
confidence interval [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 (risk ratio, 1.4; 95% CI, 0.7
to 3.1; P = 0.35).

Conclusions

The use of enoxaparin plus elastic stockings with graduated compression, as compared
with elastic stockings with graduated compression alone, was not associated with
a reduction in the rate of death from any cause among hospitalized, acutely ill medical
patients.

Discussion Summary 

  • what is the evidence for compression stockings?: note Cochrane reviews and meta-analyses
  • is there a difference in outcome between below knee and above knee stockings?
  • The MEDENOX trial primary end-point was venographic or ultrasound  deep venous thrombosis. There was a lower mortality (11 vs 14% , p=NS, low event rate) but only 3 fatal pulmonary embolism. Case for reducing mortality or fatal or massive pulmonary embolism for enoxaparin 40 mg per day not made. Note some of the event differences may have been reduction of other cardiovascular events such as myocardial infarction
  • current paper shows no difference in mortality in medical patient group between compression stockings and compression stockings and enoxaparin 40 mg subcutaneously. Unadjudicated bleeding was higher but not adjudicated bleeding events
  • how strong is the evidence of thromboembolism prohylaxis with enoxaparin in the surgical literature for: mortality, pulmonary embolism
  • rivaroxaban trials with enoxaparin as comparator: no advantage in medical patients but increased bleeding
  • apparently policy with incentives for routine prescribing of enoxaparin in medical patients is in place: on the  basis of the evidence presented the rationale for this was questioned

The presenter also provided this relevant link from theheart.org.

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