TY - JOUR
T1 - Home treatment of patients with low-risk pulmonary embolism with the oral factor Xa inhibitor rivaroxaban
T2 - Rationale and design of the HoT-PE Trial
AU - Barco, Stefano
AU - Lankeit, Mareike
AU - Binder, Harald
AU - Schellong, Sebastian
AU - Christ, Michael
AU - Beyer-Westendorf, Jan
AU - Duerschmied, Daniel
AU - Bauersachs, Rupert
AU - Empen, Klaus
AU - Held, Matthias
AU - Schwaiblmair, Martin
AU - Fonseca, Cândida
AU - Jiménez, David
AU - Becattini, Cecilia
AU - Quitzau, Kurt
AU - Konstantinides, Stavros
PY - 2016/7/1
Y1 - 2016/7/1
N2 - 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. HoTPE 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.
AB - 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. HoTPE 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.
KW - Home treatment
KW - Management trial
KW - Pulmonary embolism
KW - Risk stratification
KW - Rivaroxaban
UR - http://www.scopus.com/inward/record.url?scp=84977474603&partnerID=8YFLogxK
U2 - 10.1160/TH16-01-0004
DO - 10.1160/TH16-01-0004
M3 - Article
C2 - 27010343
AN - SCOPUS:84977474603
SN - 0340-6245
VL - 116
SP - 191
EP - 197
JO - THROMBOSIS AND HAEMOSTASIS
JF - THROMBOSIS AND HAEMOSTASIS
IS - 1
ER -