Outpatient Treatment In Patients with Acute Pulmonary Embolism: The Hestia Study

Abstract

AbstractAbstract LBA-1 Introduction:Patients with pulmonary embolism (PE) are initially treated in the hospital with low molecular weight heparin (LMWH). The most recent guideline of the American College of Chest Physicians on Antithrombotic therapy 2008 reports some small studies on outpatient treatment in patients with pulmonary embolism, which suggest outpatient treatment in selected patients with PE is potentially effective and safe but firm recommendations for clinical practice are lacking. Clinicians urgently need reliable, easy-to-use selection criteria for selection of patients with pulmonary embolism eligible for outpatient treatment. Objective:To evaluate the efficacy and safety of outpatient treatment according to predefined criteria (Hestia criteria) in patients with acute PE. Patients and Methods:Open-label, single-arm, multicenter clinical trial of patients with objectively proven acute pulmonary embolism, conducted in twelve hospitals in the Netherlands from 2008 to 2010. Follow-up was completed in September 2010. Patients with acute PE were triaged with the predefined Hestia criteria for eligibility for outpatient treatment starting with therapeutic weight adjusted doses of LMWH (Nadroparin), followed by vitamin K antagonists. All patients eligible for outpatient treatment according to the Hestia criteria, were sent home either immediately or within 24 hours after PE was objectively diagnosed. Outcome:Outpatient treatment was evaluated with respect to recurrent venous thromboembolism (VTE), including PE or deep venous thrombosis (DVT), major haemorrhage and total mortality during initial LMWH treatment and 3 months follow up. We considered outpatient treatment to be effective if the upper limit of the 95% confidence interval of the incidence of recurrent VTE would not exceed 7%. Results:Of 297 included patients, who all completed follow-up, 6 patients (2.0%; 95% confidence interval [CI], 0.8–4.3) had recurrent VTE (5 PE (1.7%), 1 DVT (0.3 %)). Three patients (1.0%, 95% CI 0.2–2.9) died during three months follow-up, but none as a result of fatal PE. One patient died of fatal intracerebral haemorrhage, the other two patients died of progressive malignancy. In addition to the patient with intracranial bleeding, one other patient had a major bleeding event (0.7 %, 95% CI 0.08%-2.4%). Conclusion:Outpatient anticoagulant treatment is effective and safe for patients with pulmonary embolism who have been selected with the Hestia criteria. (Dutch Trial Register NTR1319).Hestia criteriaIs the patient hemodynamically instable?Yes NoIs trombolysis or embolectomy necessary?Yes NoActive bleeding or high risk for bleeding?Yes NoMore than 24 hours of oxygen supply to maintain oxygen saturation > 90%?Yes NoIs pulmonary embolism diagnosed during anticoagulant treatment?Yes NoSevere pain needing intravenous pain medication for more than 24 hours?Yes NoMedical or social reason for treatment in the hospital for more than 24 hours? (infection, malignancy, no support system ie)Yes NoDoes the patient have a creatinine clearance of less than 30 ml/min?Yes NoDoes the patient have severe liver impairment?Yes NoIs the patient pregnant?Yes NoDoes the patient have a documented history of heparin induced thrombocytopenia?Yes NoIf one of the questions is answered with YES, the patient can not be treated at home in the Hestia study Disclosures:Huisman:GSK: Research Funding; Actelion: Research Funding; Bayer: Speakers Bureau; Boehringer Ingelheim: Speakers Bureau; Pfizer: Speakers Bureau.