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Thromb Haemost 2013; 110(06): 1152-1163
DOI: 10.1160/TH13-02-0170
Blood Coagulation, Fibrinolysis and Cellular Haemostasis
Schattauer GmbH

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   *
1   Washington University School of Medicine, St. Louis, Missouri, USA
,
Russell D. Hull
2   University of Calgary, Foothills Hospital, Calgary, Alberta, Canada
,
Sebastian M. Schellong
3   Municipal Hospital Dresden Friedrichstadt, Dresden, Germany
,
Victor F. Tapson
4   Duke University Medical Center, Durham, North Carolina, USA
,
Manuel Monreal
5   Hospital Germans Trias i Pujol, Barcelona, Spain
,
Meyer-Michel Samama
6   Cochin-Broca-Hôtel Dieu University Hospital, Paris, France and Biomnis Laboratories, Ivry-sur-Seine, France
,
Min Chen
7   *Sanofi US, Inc., Bridgewater, New Jersey, USA
,
Bruno Deslandes
8   Sanofi, Paris, France
,
Alexander G. G. Turpie
9   McMaster University and HHS McMaster Clinic, Hamilton, Ontario, Canada
› Institutsangaben Financial support: Sanofi sponsored the EXCLAIM study. Sanofi U.S., Inc., funded editorial/writing support in the preparation of this manuscript. The authors claim full responsibility for all content and editorial decisions, and they did not receive financial support or other form of compensation related to the development of the manuscript.
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Publikationsverlauf

Received: 25. Februar 2013

Accepted after major revision: 13. August 2013

Publikationsdatum:
30. November 2017 (online)

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Summary

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-hoc analysis 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 - pulmonary embolism - deep-vein thrombosis - enoxaparin - thromboprophylaxis

* Dr. Chen was an employee of Sanofi at the time of this study.


 

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