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
1  Center for Thrombosis and Hemostasis (CTH), University Medical Center of the Johannes Gutenberg University, Mainz, Germany
,
Mareike Lankeit
1  Center for Thrombosis and Hemostasis (CTH), University Medical Center of the Johannes Gutenberg University, Mainz, Germany
,
Harald Binder
2  Institute of Medical Biostatistics, Epidemiology and Informatics (IMBEI) at the University Medical Center Mainz, Germany
,
Sebastian Schellong
3  Municipal Hospital of Dresden-Friedrichstadt, Dresden, Germany
,
Michael Christ
4  Department of Emergency and Critical Care Medicine, Paracelsus Medical University, General Hospital, Nuernberg, Germany
,
Jan Beyer-Westendorf
5  Center for Vascular Medicine and Department of Medicine III, Division of Angiology, University Hospital ‘Carl Gustav Carus’, Dresden, Germany
,
Daniel Duerschmied
6  Heart Center, University of Freiburg, Freiburg, Germany
,
Rupert Bauersachs
7  Department of Vascular Medicine, Klinikum Darmstadt GmbH, Darmstadt, Germany
,
Klaus Empen
8  Department of Internal Medicine, Ernst Moritz Arndt University, Greifswald, Germany
,
Matthias Held
9  Medical Mission Hospital, Department of Internal Medicine, Academic Teaching Hospital of the Julius-Maximilian University of Wuerzburg, Wuerzburg, Germany
,
Martin Schwaiblmair
10  Klinikum Augsburg, I. Medizinische Klinik, Augsburg, Germany
,
Cândida Fonseca
11  Hospital S. Francisco Xavier/CHLO, Faculdade de Ciências Médicas, Universidade Nova de Lisboa, Lisbon, Portugal
,
David Jiménez
12  Respiratory Department, Ramón y Cajal Hospital, IRYCIS, Madrid, Spain
,
Cecilia Becattini
13  Internal and Cardiovascular Medicine Stroke Unit, University of Perugia, Italy
,
Kurt Quitzau
1  Center for Thrombosis and Hemostasis (CTH), University Medical Center of the Johannes Gutenberg University, Mainz, Germany
,
Stavros Konstantinides
1  Center for Thrombosis and Hemostasis (CTH), University Medical Center of the Johannes Gutenberg University, Mainz, Germany
14  Department of Cardiology, Democritus University of Thrace, Alexandroupolis, Greece
› Author Affiliations
Financial support: HoT-PE is an independent, investigator-initiated trial. The study has an academic sponsor (Center for Thrombosis and Hemostasis, University Medical Center Mainz, Germany) and is supported by public funding (German Federal Ministry of Education and Research; BMBF 01E01003). In addition, the sponsor has obtained the study drug (rivaroxaban) and a grant from the market authorisation holder of rivaroxaban, Bayer HealthCare. The authors are solely responsible for the design and conduct of the HoT PE trial study, for all future study analyses, and for the drafting and editing of reports and publications and their final contents.
Further Information

Publication History

Received: 05 January 2016

Accepted after major revision: 03 March 2016

Publication Date:
27 November 2017 (online)

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.