Early discharge and home treatment of patients with low-risk pulmonary embolism with the oral factor Xa inhibitor rivaroxaban : an international multicentre single-arm clinical trial

Show full item record



Permalink

http://hdl.handle.net/10138/314238

Citation

HoT-PE Investigators , Barco , S , Schmidtmann , I , Ageno , W , Harjola , V-P & Lankeit , M 2020 , ' Early discharge and home treatment of patients with low-risk pulmonary embolism with the oral factor Xa inhibitor rivaroxaban : an international multicentre single-arm clinical trial ' , European Heart Journal , vol. 41 , no. 4 , pp. 509-518 . https://doi.org/10.1093/eurheartj/ehz367

Title: Early discharge and home treatment of patients with low-risk pulmonary embolism with the oral factor Xa inhibitor rivaroxaban : an international multicentre single-arm clinical trial
Author: HoT-PE Investigators; Barco, Stefano; Schmidtmann, Irene; Ageno, Walter; Harjola, Veli-Pekka; Lankeit, Mareike
Other contributor: University of Helsinki, HUS Emergency Medicine and Services


Date: 2020-01-21
Language: eng
Number of pages: 10
Belongs to series: European Heart Journal
ISSN: 0195-668X
DOI: https://doi.org/10.1093/eurheartj/ehz367
URI: http://hdl.handle.net/10138/314238
Abstract: Aims To investigate the efficacy and safety of early transition from hospital to ambulatory treatment in low-risk acute PE, using the oral factor Xa inhibitor rivaroxaban. Methods and results We conducted a prospective multicentre single-arm investigator initiated and academically sponsored management trial in patients with acute low-risk PE (EudraCT Identifier 2013-001657-28). Eligibility criteria included absence of (i) haemodynamic instability, (ii) right ventricular dysfunction or intracardiac thrombi, and (iii) serious comorbidities. Up to two nights of hospital stay were permitted. Rivaroxaban was given at the approved dose for PE for >= 3 months. The primary outcome was symptomatic recurrent venous thromboembolism (VTE) or PE-related death within 3 months of enrolment. An interim analysis was planned after the first 525 patients, with prespecified early termination of the study if the null hypothesis could be rejected at the level of alpha = 0.004 ( Conclusion Early discharge and home treatment with rivaroxaban is effective and safe in carefully selected patients with acute low-risk PE. The results of the present trial support the selection of appropriate patients for ambulatory treatment of PE.
Subject: Pulmonary embolism
Home treatment
Right ventricular dysfunction
Management trial
Rivaroxaban
Risk stratification
OUTPATIENT TREATMENT
INPATIENT TREATMENT
EUROPEAN-SOCIETY
MANAGEMENT
HOSPITALIZATION
THROMBOSIS
3126 Surgery, anesthesiology, intensive care, radiology
3121 General medicine, internal medicine and other clinical medicine
Rights:


Files in this item

Total number of downloads: Loading...

Files Size Format View
ehz367.pdf 700.7Kb PDF View/Open

This item appears in the following Collection(s)

Show full item record