Subscribe to RSS
Home treatment of patients with low-risk pulmonary embolism with the oral factor Xa inhibitor rivaroxabanRationale and design of the HoT-PE Trial 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.
05 January 2016
Accepted after major revision: 03 March 2016
27 November 2017 (online)
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.
- 1 Raskob GE. et al. Thrombosis: A major contributor to global disease burden. Thromb Haemost 2014; 112: 843-852.
- 2 Konstantinides SV. et al. 2014 ESC Guidelines on the diagnosis and management of acute pulmonary embolism: The Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC)Endorsed by the European Respiratory Society (ERS). Eur Heart J 2014; 35: 3033-3073.
- 3 Aujesky D. et al. Outpatient versus inpatient treatment for patients with acute pulmonary embolism: an international, open-label, randomised, non-inferiority trial. Lancet 2011; 378: 41-48.
- 4 Zondag W. et al. Outpatient treatment in patients with acute pulmonary embolism: the Hestia Study. J Thromb Haemost 2011; 09: 1500-1507.
- 5 Agterof MJ. et al. Out of hospital treatment of acute pulmonary embolism in patients with a low NT-proBNP level. J Thromb Haemost 2010; 08: 1235-1241.
- 6 Otero R. et al. Home treatment in pulmonary embolism. Thromb Res 2010; 126: e1-e5.
- 7 Agnelli G. et al. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med 2013; 369: 799-808.
- 8 Buller HR. et al. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med 2012; 366: 1287-1297.
- 9 Mahan CE. et al. Venous thromboembolism: annualised United States models for total, hospital-acquired and preventable costs utilising long-term attack rates. Thromb Haemost 2012; 108: 291-302.
- 10 Barco S. et al. European Union-28: An annualised cost-of-illness model for venous thromboembolism. Thromb Haemost 2016; 115: 800-808.
- 11 Herdman M. et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res 2011; 20: 1727-1736.
- 12 Klok FA. et al. Quality of life after pulmonary embolism: validation of the PEmb-QoL Questionnaire. J Thromb Haemost 2010; 08: 523-532.
- 13 Cano SJ. et al. The Anti-Clot Treatment Scale (ACTS) in clinical trials: crosscultural validation in venous thromboembolism patients. Health Qual Life Outcomes 2012; 10: 120.
- 14 Schulman S, Kearon C. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost 2005; 03: 692-694.
- 15 Zondag W. et al. Outpatient versus inpatient treatment in patients with pulmonary embolism: a meta-analysis. Eur Respir J 2013; 42: 134-144.
- 16 Aujesky D. et al. Derivation and validation of a prognostic model for pulmonary embolism. Am J Respir Crit Care Med 2005; 172: 1041-1046.
- 17 Venetz C. et al. A comparison of the original and simplified Pulmonary Embolism Severity Index. Thromb Haemost 2011; 106: 423-428.
- 18 Jimenez D. et al. Simplification of the pulmonary embolism severity index for prognostication in patients with acute symptomatic pulmonary embolism. Arch Intern Med 2010; 170: 1383-1389.
- 19 Aujesky D. et al. Validation of a model to predict adverse outcomes in patients with pulmonary embolism. Eur Heart J 2006; 27: 476-481.
- 20 Bauersachs R. et al. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010; 363: 2499-2510.
- 21 Eerenberg ES. et al. Clinical impact and course of major bleeding with rivaroxaban and vitamin K antagonists. J Thromb Haemost 2015; 13: 1590-1596.
- 22 Prins MH. et al. Patient-reported treatment satisfaction with oral rivaroxaban versus standard therapy in the treatment of pulmonary embolism; results from the EINSTEIN PE trial. Thromb Res 2015; 135: 281-288.
- 23 Bamber L. et al. Cost-effectiveness analysis of treatment of venous thromboembolism with rivaroxaban compared with combined low molecular weight heparin/vitamin K antagonist. Thromb J 2015; 13: 20.