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Home treatment of patients with low-risk pulmonary embolism with the oral factor Xa inhibitor rivaroxaban

Journal: Thrombosis and Haemostasis
ISSN: 0340-6245
DOI: https://doi.org/10.1160/TH16-01-0004
Issue: 2016: 116/1 (July) pp. 1-203
Pages: 191-197
Ahead of Print: 2016-03-24

Home treatment of patients with low-risk pulmonary embolism with the oral factor Xa inhibitor rivaroxaban

Rationale and design of the HoT-PE Trial

Online Supplementary Material

Erratum in Issue 116.4

S. Barco (1), M. Lankeit (1), H. Binder (2), S. Schellong (3), M. Christ (4), J. Beyer-Westendorf (5), D. Duerschmied (6), R. Bauersachs (7), K. Empen (8), M. Held (9), M. Schwaiblmair (10), C. Fonseca (11), D. Jiménez (12), C. Becattini (13), K. Quitzau (1), S. Konstantinides (1, 14)

(1) Center for Thrombosis and Hemostasis (CTH), University Medical Center of the Johannes Gutenberg University, Mainz, Germany; (2) Institute of Medical Biostatistics, Epidemiology and Informatics (IMBEI) at the University Medical Center Mainz, Germany; (3) Municipal Hospital of Dresden-Friedrichstadt, Dresden, Germany; (4) Department of Emergency and Critical Care Medicine, Paracelsus Medical University, General Hospital, Nuernberg, Germany; (5) Center for Vascular Medicine and Department of Medicine III, Division of Angiology, University Hospital ’Carl Gustav Carus’, Dresden, Germany; (6) Heart Center, University of Freiburg, Freiburg, Germany; (7) Department of Vascular Medicine, Klinikum Darmstadt GmbH, Darmstadt, Germany; (8) Department of Internal Medicine, Ernst Moritz Arndt University, Greifswald, Germany; (9) Medical Mission Hospital, Department of Internal Medicine, Academic Teaching Hospital of the Julius-Maximilian University of Wuerzburg, Wuerzburg, Germany; (10) Klinikum Augsburg, I. Medizinische Klinik, Augsburg, Germany; (11) Hospital S. Francisco Xavier/CHLO, Faculdade de Ciências Médicas, Universidade Nova de Lisboa, Lisbon, Portugal; (12) Respiratory Department, Ramón y Cajal Hospital, IRYCIS, Madrid, Spain; (13) Internal and Cardiovascular Medicine - Stroke Unit, University of Perugia, Italy; (14) Department of Cardiology, Democritus University of Thrace, Alexandroupolis, Greece

Keywords

pulmonary embolism, home treatment, risk stratification, rivaroxaban, management trial

Summary

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.

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