SYMPTOMS
Trial question
What is the role of enoxaparin in medically ill, hospitalized older adult patients with symptomatic VTE?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
60.0% female
40.0% male
N = 2541
2541 patients (1513 female, 1028 male).
Inclusion criteria: older patients aged > 70 years hospitalized for acute medical conditions.
Key exclusion criteria: hospitalization for a planned medical procedure or for reasons other than an acute medical condition; contraindication to LMWH; requirement of anticoagulant therapy for any indication or receipt of any anticoagulant therapy > 48 hours before inclusion; organ lesion prone to bleeding, hemorrhagic events, or bleeding tendency due to hemostasis disorders.
Interventions
N=1278 enoxaparin (at a dose of 40 mg/day for 6-14 days).
N=1263 placebo (matching placebo for 6-14 days).
Primary outcome
Symptomatic venous thromboembolism or venous thromboembolism-related death at day 30
1.8%
2.2%
2.2 %
1.7 %
1.1 %
0.6 %
0.0 %
Enoxaparin
Placebo
No significant
difference ↔
No significant difference in symptomatic VTE or VTE-related death at day 30 (1.8% vs. 2.2%; ARD -0.4, 95% CI -1.5 to 0.7).
Secondary outcomes
No significant difference in symptomatic VTE or VTE-related death at day 90 (2% vs. 3%; ARD -1, 95% CI -2.2 to 0.2).
No significant difference in atherothrombotic CV events at day 30 (0.7% vs. 0.6%; AD 0.1%, 95% CI -0.5 to 0.7).
No significant difference in CV death at day 30 (1.3% vs. 0.8%; AD 0.5%, 95% CI -1.2 to 2.2).
Safety outcomes
No significant difference in major bleeding or clinically relevant nonmajor bleeding at day 30.
Conclusion
In older patients aged > 70 years hospitalized for acute medical conditions, enoxaparin was not superior to placebo with respect to symptomatic VTE or VTE-related death at day 30.
Reference
Dominique Mottier, Philippe Girard, Francis Couturaud et al. Enoxaparin versus Placebo to Prevent Symptomatic Venous Thromboembolism in Hospitalized Older Adult Medical Patients. NEJM Evid. 2023 Aug;2(8):EVIDoa2200332.
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