title: Home treatment of patients with low-risk pulmonary embolism with the oral factor Xa inhibitor rivaroxaban. Rationale and design of the HoT-PE Trial.
abstract: Pulmonary embolism (PE) is a potentially life-threatening acute cardiovascular syndrome. However, more than 95 % of patients are haemodynamically stable at presentation, and among them are patients at truly low risk who may qualify for immediate or early discharge. The Home Treatment of Pulmonary Embolism (HoT-PE) study is a prospective international multicentre single-arm phase 4 management (cohort) trial aiming to determine whether home treatment of acute low-risk PE with the oral factor Xa inhibitor rivaroxaban is feasible, effective, and safe. Patients with confirmed PE, who have no right ventricular dysfunction or free floating thrombi in the right atrium or ventricle, are eligible if they meet none of the exclusion criteria indicating haemodynamic instability, serious comorbidity or any condition mandating hospitalisation, or a familial/social environment unable to support home treatment. The first dose of rivaroxaban is given in hospital, and patients are discharged within 48 hours of presentation. Rivaroxaban is taken for at least three months. The primary outcome is symptomatic recurrent venous thromboembolism or PE-related death within three months of enrolment. Secondary outcomes include quality of life and patient satisfaction, and health care resource utilisation compared to existing data on standard-duration hospital treatment. HoT-PE is planned to analyse 1,050 enrolled patients, providing 80 % power to reject the null hypothesis that the recurrence rate of venous thromboembolism is >3 % with α≤0.05. If the hypothesis of HoT-PE is confirmed, early discharge and out-of-hospital treatment may become an attractive, potentially cost-saving option for a significant proportion of patients with acute PE.
authors.forename: Stefano
authors.initials: S
authors.lastname: Barco
authors.forename: Mareike
authors.initials: M
authors.lastname: Lankeit
authors.forename: Harald
authors.initials: H
authors.lastname: Binder
authors.forename: Sebastian
authors.initials: S
authors.lastname: Schellong
authors.forename: Michael
authors.initials: M
authors.lastname: Christ
authors.forename: Jan
authors.initials: J
authors.lastname: Beyer-Westendorf
authors.forename: Daniel
authors.initials: D
authors.lastname: Duerschmied
authors.forename: Rupert
authors.initials: R
authors.lastname: Bauersachs
authors.forename: Klaus
authors.initials: K
authors.lastname: Empen
authors.forename: Matthias
authors.initials: M
authors.lastname: Held
authors.forename: Martin
authors.initials: M
authors.lastname: Schwaiblmair
authors.forename: Cândida
authors.initials: C
authors.lastname: Fonseca
authors.forename: David
authors.initials: D
authors.lastname: Jiménez
authors.forename: Cecilia
authors.initials: C
authors.lastname: Becattini
authors.forename: Kurt
authors.initials: K
authors.lastname: Quitzau
authors.affiliation: Stavros V. Konstantinides, MD, FESC, Center for Thrombosis and Hemostasis, University Medical Center Mainz, Langenbeckstrasse 1, Building 403, 55131 Mainz, Germany, Tel.: +49 6131 17 8382, Fax: +49 6131 17 3456, E-mail: stavros.konstantinides@unimedizin-mainz.de.
authors.forename: Stavros
authors.initials: S
authors.lastname: Konstantinides
mesh_terms: D000284:Administration, Oral; D065427:Factor Xa Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D006699:Home Care Services; D006801:Humans; D010351:Patient Discharge; D011446:Prospective Studies; D011655:Pulmonary Embolism / Q000188:drug therapy*; D011788:Quality of Life; D012008:Recurrence; D012307:Risk Factors; D000069552:Rivaroxaban / Q000008:administration & dosage / Q000627:therapeutic use*; D012646:Self Administration
chemical_list: D065427:Factor Xa Inhibitors; D000069552:Rivaroxaban
keywords: Pulmonary embolism; home treatment; management trial; risk stratification; rivaroxaban