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

Stefano Barco; Mareike Lankeit; Harald Binder; Sebastian Schellong; Michael Christ; Jan Beyer-Westendorf; Daniel Duerschmied; Rupert Bauersachs; Klaus Empen; Matthias Held; Martin Schwaiblmair; Cândida Fonseca; David Jiménez; Cecilia Becattini; Kurt Quitzau; Stavros Konstantinides

doi:10.1160/TH16-01-0004

Thrombosis and Haemostasis, Inhaltsverzeichnis

Thromb Haemost 2016; 116(01): 191-197
DOI: 10.1160/TH16-01-0004

Trial Protocol Design Paper

Schattauer GmbH

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

Rationale and design of the HoT-PE Trial

Stefano Barco

¹Center for Thrombosis and Hemostasis (CTH), University Medical Center of the Johannes Gutenberg University, Mainz, Germany

,

Mareike Lankeit

¹Center for Thrombosis and Hemostasis (CTH), University Medical Center of the Johannes Gutenberg University, Mainz, Germany

,

Harald Binder

²Institute of Medical Biostatistics, Epidemiology and Informatics (IMBEI) at the University Medical Center Mainz, Germany

,

Sebastian Schellong

³Municipal Hospital of Dresden-Friedrichstadt, Dresden, Germany

,

Michael Christ

⁴Department of Emergency and Critical Care Medicine, Paracelsus Medical University, General Hospital, Nuernberg, Germany

,

Jan Beyer-Westendorf

⁵Center for Vascular Medicine and Department of Medicine III, Division of Angiology, University Hospital ‘Carl Gustav Carus’, Dresden, Germany

,

Daniel Duerschmied

⁶Heart Center, University of Freiburg, Freiburg, Germany

,

Rupert Bauersachs

⁷Department of Vascular Medicine, Klinikum Darmstadt GmbH, Darmstadt, Germany

,

Klaus Empen

⁸Department of Internal Medicine, Ernst Moritz Arndt University, Greifswald, Germany

,

Matthias Held

⁹Medical Mission Hospital, Department of Internal Medicine, Academic Teaching Hospital of the Julius-Maximilian University of Wuerzburg, Wuerzburg, Germany

,

Martin Schwaiblmair

¹⁰Klinikum Augsburg, I. Medizinische Klinik, Augsburg, Germany

,

Cândida Fonseca

¹¹Hospital S. Francisco Xavier/CHLO, Faculdade de Ciências Médicas, Universidade Nova de Lisboa, Lisbon, Portugal

,

David Jiménez

¹²Respiratory Department, Ramón y Cajal Hospital, IRYCIS, Madrid, Spain

,

Cecilia Becattini

¹³Internal and Cardiovascular Medicine Stroke Unit, University of Perugia, Italy

,

Kurt Quitzau

¹Center for Thrombosis and Hemostasis (CTH), University Medical Center of the Johannes Gutenberg University, Mainz, Germany

,

Stavros Konstantinides

¹Center for Thrombosis and Hemostasis (CTH), University Medical Center of the Johannes Gutenberg University, Mainz, Germany

¹⁴Department of Cardiology, Democritus University of Thrace, Alexandroupolis, Greece

› Institutsangaben

Abstract

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 lowrisk 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.

Keywords

Pulmonary embolism - home treatment - management trial - rivaroxaban - risk stratification

Volltext

Referenzen

References
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