TY - JOUR
T1 - Impact of age on the efficacy and safety of extended-duration thromboprophylaxis in medical patients
T2 - Subgroup analysis from the EXCLAIM randomised trial
AU - Yusen, Roger D.
AU - Hull, Russell D.
AU - Schellong, Sebastian M.
AU - Tapson, Victor F.
AU - Monreal, Manuel
AU - Samama, Meyer Michel
AU - Chen, Min
AU - Deslandes, Bruno
AU - Turpie, Alexander G.G.
PY - 2013/10/2
Y1 - 2013/10/2
N2 - 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.
AB - 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.
KW - Deep-vein thrombosis
KW - Enoxaparin
KW - Pulmonary embolism
KW - Thromboprophylaxis
KW - Venous thromboembolism
UR - http://www.scopus.com/inward/record.url?scp=84888405189&partnerID=8YFLogxK
U2 - 10.1160/TH13-02-0170
DO - 10.1160/TH13-02-0170
M3 - Article
C2 - 24085227
AN - SCOPUS:84888405189
SN - 0340-6245
VL - 110
SP - 1152
EP - 1163
JO - Thrombosis and haemostasis
JF - Thrombosis and haemostasis
IS - 6
ER -