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

Roger D. Yusen, Russell D. Hull, Sebastian M. Schellong, Victor F. Tapson, Manuel Monreal, Meyer Michel Samama, Min Chen, Bruno Deslandes, Alexander G.G. Turpie

Research output: Contribution to journalArticlepeer-review

12 Scopus citations

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.

Original languageEnglish
Pages (from-to)1152-1163
Number of pages12
JournalThrombosis and haemostasis
Volume110
Issue number6
DOIs
StatePublished - Oct 2 2013

Keywords

  • Deep-vein thrombosis
  • Enoxaparin
  • Pulmonary embolism
  • Thromboprophylaxis
  • Venous thromboembolism

Fingerprint

Dive into the research topics of 'Impact of age on the efficacy and safety of extended-duration thromboprophylaxis in medical patients: Subgroup analysis from the EXCLAIM randomised trial'. Together they form a unique fingerprint.

Cite this