Thromb Haemostasis
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Randomized Controlled Trial Comparative Study
Oral dabigatran versus enoxaparin for thromboprophylaxis after primary total hip arthroplasty (RE-NOVATE II*). A randomised, double-blind, non-inferiority trial.
This trial compared the efficacy and safety of oral dabigatran, a direct thrombin inhibitor, versus subcutaneous enoxaparin for extended thromboprophylaxis in patients undergoing total hip arthroplasty. A total of 2,055 patients were randomised to 28-35 days treatment with oral dabigatran, 220 mg once-daily, starting with a half-dose 1-4 hours after surgery, or subcutaneous enoxaparin 40 mg once-daily, starting the evening before surgery. The primary efficacy outcome was a composite of total venous thromboembolism [VTE] (venographic or symptomatic) and death from all-causes. ⋯ The incidence of adverse events, including liver enzyme elevations and cardiac events, during treatment was similar between the groups. Extended prophylaxis with oral dabigatran 220 mg once-daily was as effective as subcutaneous enoxaparin 40 mg once-daily in reducing the risk of VTE after total hip arthroplasty, and superior to enoxaparin for reducing the risk of major VTE. The risk of bleeding and safety profiles were similar.
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The Pulmonary Embolism Severity Index (PESI) has been shown to predict 30 and 90 day mortality after PE. However, whether the PESI predicts patients who will be free of clinically adverse outcomes during a typical hospitalisation is not known. Retrospective analysis of Emergency Department patients with PE from May 2006 to April 2008. ⋯ Sixty-one (26%) patients had the outcome, of whom nine (14%) were characterised as low risk by the PESI. Test characteristics were: sensitivity 86% (95% confidence interval [CI]: 75%-93%), specificity 55% (95% CI: 47%-62%), NPV 63% (95% CI: 55%-70%), PPV 40% (95% CI: 31%-49%), LR(+) 1.9 (95% CI: 1.57-2.30) and LR(-) 0.26 (95% CI: 0.14-0.48). Of the patients who had an adverse clinical event or required a hospital-based intervention within the first five days after PE diagnosis, 14% were categorised by the PESI as safe for discharge [corrected] .