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J. Thromb. Haemost. · Aug 2011
Multicenter Study Clinical TrialOutpatient treatment in patients with acute pulmonary embolism: the Hestia Study.
- W Zondag, I C M Mos, D Creemers-Schild, A D M Hoogerbrugge, O M Dekkers, J Dolsma, M Eijsvogel, L M Faber, H M A Hofstee, M M C Hovens, G J P M Jonkers, K W van Kralingen, M J H A Kruip, T Vlasveld, M J M de Vreede, M V Huisman, and Hestia Study Investigators.
- Section of Vascular Medicine, Department of General Internal Medicine-Endocrinology, LUMC, Leiden, The Netherlands. W.Zondag@LUMC.nl
- J. Thromb. Haemost. 2011 Aug 1; 9 (8): 1500-7.
BackgroundTraditionally, patients with pulmonary embolism (PE) are initially treated in the hospital with low molecular weight heparin (LMWH). The results of a few small non-randomized studies suggest that, in selected patients with proven PE, outpatient treatment is potentially feasible and safe.ObjectiveTo evaluate the efficacy and safety of outpatient treatment according to predefined criteria in patients with acute PE.Patients And MethodsA prospective cohort study of patients with objectively proven acute PE was conducted in 12 hospitals in The Netherlands between 2008 and 2010. Patients with acute PE were triaged with the predefined criteria for eligibility for outpatient treatment, with LMWH (nadroparin) followed by vitamin K antagonists. All patients eligible for outpatient treatment were sent home either immediately or within 24 h after PE was objectively diagnosed. Outpatient treatment was evaluated with respect to recurrent venous thromboembolism (VTE), including PE or deep vein thrombosis (DVT), major hemorrhage and total mortality during 3 months of follow-up.ResultsOf 297 included patients, who all completed the follow-up, six (2.0%; 95% confidence interval [CI] 0.8-4.3) had recurrent VTE (five PE [1.7%] and one DVT [0.3%]). Three patients (1.0%, 95% CI 0.2-2.9) died during the 3 months of follow-up, none of fatal PE. Two patients had a major bleeding event, one of which was fatal intracranial bleeding (0.7%, 95% CI 0.08-2.4).ConclusionPatients with PE selected for outpatient treatment with predefined criteria can be treated with anticoagulants on an outpatient basis. (Dutch Trial Register No 1319; http://www.trialregister.nl/trialreg/index.asp).© 2011 International Society on Thrombosis and Haemostasis.
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