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Thromb Haemost. 2013 Dec;110(6):1152-63. doi: 10.1160/TH13-02-0170. Epub 2013 Oct 2.

Impact of age on the efficacy and safety of extended-duration thromboprophylaxis in medical patients. Subgroup analysis from the EXCLAIM randomised trial.

Author information

1
Roger D. Yusen, MD, MPH, Washington University School of Medicine, Campus Box 8052, 660 S. Euclid Ave, St Louis, MO 63110, USA, Tel.: +1 314 454 8764, Fax: +1 314 454 5571, E-mail: ryusen@dom.wustl.edu.

Abstract

The EXCLAIM study enrolled hospitalised acutely ill medical patients with age >40 years and recently-reduced mobility into a trial of extended-duration anticoagulant thromboprophylaxis. This post-hocanalysis evaluated the impact of age on patient outcomes. After completion of open-label therapy with enoxaparin 40 mg once-daily (10 ± 4 days), eligible patients underwent randomisation to receive double-blind therapy of enoxaparin (n=2,975) or placebo (n=2,988) for 28 ± 4 days. During follow-up, the venous thromboembolism (VTE) risk increased with age in both treatment groups. In patients with age >75 years, those who received extended-duration enoxaparin had lower incidence of VTE (2.5% vs 6.7%; absolute difference [AD] [95% confidence interval]: -4.2% [-6.5, -2.0]), proximal deep-vein thrombosis (2.5% vs 6.6%; AD -4.1% [-6.2, -2.0]), and symptomatic VTE (0.3% vs 1.5%; AD -1.2% [-2.2, -0.3]), in comparison to those who received placebo. In patients with age ≤75 years, those who received enoxaparin had reduced VTE (2.4% vs 2.8%; AD -0.4% [-1.5, 0.7]) and symptomatic VTE (0.2% vs 0.7%; AD -0.6% [-1.0, -0.1]) in comparison to those who received placebo. In both age subgroups, patients who received enoxaparin had increased rates of major bleeding versus those who received placebo: age >75 years (0.6% vs 0.2%; AD +0.3% [-0.2, 0.9], respectively); age ≤75 years (0.7% vs 0.2%; AD +0.5% [0.1, 0.9]). Patients in both age subgroups that received enoxaparin had similar low bleeding rates (0.6% and 0.7%, respectively). VTE risk increased with age, though the bleeding risk did not. Patients with age >75 years had a more favourable benefit-to-harm profile than younger patients.

KEYWORDS:

Venous thromboembolism; deep-vein thrombosis; enoxaparin; pulmonary embolism; thromboprophylaxis

PMID:
24085227
DOI:
10.1160/TH13-02-0170
[Indexed for MEDLINE]

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