Extended-duration venous thromboembolism prophylaxis in acutely Ill medical patients with recently reduced mobility: a randomized trial

Hull, Russell D. ; Schellong, Sebastian M. ; Tapson, Victor F. ; Monreal, Manuel ; Samama, Meyer-Michel ; Nicol, Philippe ; Vicaut, Eric ; Turpie, Alexander G. G. ; Yusen, Roger D. ; Sharma, S. K. (2010) Extended-duration venous thromboembolism prophylaxis in acutely Ill medical patients with recently reduced mobility: a randomized trial Annals of Internal Medicine, 153 (1). pp. 8-18. ISSN 0003-4819

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Official URL: http://www.annals.org/content/153/1/8.short

Abstract

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.

Item Type:Article
Source:Copyright of this article belongs to American College of Physicians.
ID Code:69179
Deposited On:08 Nov 2011 11:37
Last Modified:08 Nov 2011 11:37

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