Does Venous Thromboembolism Prophylaxis Lower 30-Day Mortality in Medical Inpatients?

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Does Venous Thromboembolism Prophylaxis Lower 30-Day Mortality in Medical Inpatients?

In a randomized trial, enoxaparin failed to do so.

Despite widespread use of low-molecular-weight heparin to prevent venous thromboembolism (VTE) in medical inpatients, the effect of this practice on mortality is unclear. In a trial conducted mainly in China and India, 8300 acutely ill medical inpatients were given graduated compression stockings and, additionally, were randomized to receive daily enoxaparin (40 mg) or placebo during hospitalization (6–14 days). Patients were eligible for enrollment if they had decompensated congestive heart failure; active cancer; or severe systemic infection plus chronic lung disease, obesity, previous VTE, or advanced age (>60).

All-cause mortality at 30 days, the primary outcome, was identical in the two groups — about 5%. All other efficacy endpoints (e.g., cardiopulmonary death, sudden death, pulmonary embolism) also occurred with similar frequency in both groups at 14, 30, and 90 days. Bleeding events occurred only slightly more often with enoxaparin than with placebo (2.2% vs. 1.5%), but this difference was statistically significant.

Comment: What should we make of this completely negative study? Were the compression stockings effective, thus diminishing the benefit of add-on enoxaparin? Can we generalize from these mainly Asian patients to other populations and other countries? The authors conclude that "pharmacologic thromboprophylaxis continues to have proven benefits in preventing VTE" in medical inpatients, but this comment refers mainly to preventing asymptomatic deep venous thrombosis.

A recent guideline from the American College of Physicians questions the trend to provide near-universal VTE prophylaxis to medical inpatients (JW Gen Med Nov 22 2011). This new study gives us further impetus to re-examine that practice.

— Allan S. Brett, MD

Published in Journal Watch General Medicine January 19, 2012

Citation(s):

Kakkar AK et al. Low-molecular-weight heparin and mortality in acutely ill medical patients. N Engl J Med 2011 Dec 29; 365:2463. (http://dx.doi.org/10.1056/NEJMoa1111288)

Medline abstract (Free)

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