Extended-duration enoxaparin reduced VTE incidence compared with placebo (2.5% vs. 4%; absolute risk difference -1.53%) but increased major bleeding events (0.8% vs. 0.3%).
RCT (n=5,963)
Double-blind
Computer-generated
Yes
Does extended-duration enoxaparin reduce venous thromboembolism in acutely ill medical patients with recently reduced mobility?
Extended-duration enoxaparin prophylaxis reduces VTE risk but increases major bleeding in acutely ill medical patients with reduced mobility.
Absolute Risk Reduction: 1.53 (95% CI 0.52–2.54)
Absolute Event Rate: 2.5% vs 4%
Absolute Risk Reduction: 1.53%
BACKGROUND: Extended-duration low-molecular-weight heparin has been shown to prevent venous thromboembolism (VTE) in high-risk surgical patients. OBJECTIVE: To evaluate the efficacy and safety of extended-duration enoxaparin thromboprophylaxis in acutely ill medical patients. DESIGN: Randomized, parallel, placebo-controlled trial. Randomization was computer-generated. Allocation was centralized. Patients, caregivers, and outcome assessors were blinded to group assignment. (ClinicalTrials.gov registration number: NCT00077753) SETTING: 370 sites in 20 countries across North and South America, Europe, and Asia. PATIENTS: Acutely ill medical patients 40 years or older with recently reduced mobility (bed rest or sedentary without level 1 or with level 2 bathroom privileges). Eligibility criteria for patients with level 2 immobility were amended to include only those who had additional VTE risk factors (age >75 years, history of VTE, or active or previous cancer) after interim analyses suggested lower-than-expected VTE rates. INTERVENTION: Enoxaparin, 40 mg/d subcutaneously (2975 patients), or placebo (2988 patients), for 28 +/- 4 days after receiving open-label enoxaparin for an initial 10 +/- 4 days. MEASUREMENTS: Incidence of VTE up to day 28 and of major bleeding events up to 48 hours after the last study treatment dose. RESULTS: Extended-duration enoxaparin reduced VTE incidence compared with placebo (2.5% vs. 4%; absolute risk difference favoring enoxaparin, -1.53% 95.8% CI, -2.54% to -0.52%). Enoxaparin increased major bleeding events (0.8% vs. 0.3%; absolute risk difference favoring placebo, 0.51% 95% CI, 0.12% to 0.89%). The benefits of extended-duration enoxaparin seemed to be restricted to women, patients older than 75 years, and those with level 1 immobility. LIMITATION: Estimates of efficacy and safety for the overall trial population are difficult to interpret because of the change in eligibility criteria during the trial. CONCLUSION: Use of extended-duration enoxaparin reduces VTE more than it increases major bleeding events in acutely ill medical patients with level 1 immobility, those older than 75 years, and women. PRIMARY FUNDING SOURCE: Sanofi-aventis.
Hull et al. (Tue,) conducted a rct in Acutely ill medical patients with recently reduced mobility (n=5,963). Enoxaparin vs. Placebo was evaluated on Incidence of VTE up to day 28 (Absolute risk difference -1.53%, 95% CI -2.54% to -0.52%). Extended-duration enoxaparin reduced VTE incidence compared with placebo (2.5% vs. 4%; absolute risk difference -1.53%) but increased major bleeding events (0.8% vs. 0.3%).
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