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

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dc.contributor.author HoT-PE Investigators
dc.contributor.author Barco, Stefano
dc.contributor.author Schmidtmann, Irene
dc.contributor.author Ageno, Walter
dc.contributor.author Harjola, Veli-Pekka
dc.contributor.author Lankeit, Mareike
dc.date.accessioned 2020-04-22T08:24:01Z
dc.date.available 2020-04-22T08:24:01Z
dc.date.issued 2020-01-21
dc.identifier.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
dc.identifier.other PURE: 135841885
dc.identifier.other PURE UUID: cde22e36-3c37-4449-98d4-8a2718d82eb6
dc.identifier.other WOS: 000521323000008
dc.identifier.uri http://hdl.handle.net/10138/314238
dc.description.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. en
dc.format.extent 10
dc.language.iso eng
dc.relation.ispartof European Heart Journal
dc.rights cc_by_nc
dc.rights.uri info:eu-repo/semantics/openAccess
dc.subject Pulmonary embolism
dc.subject Home treatment
dc.subject Right ventricular dysfunction
dc.subject Management trial
dc.subject Rivaroxaban
dc.subject Risk stratification
dc.subject OUTPATIENT TREATMENT
dc.subject INPATIENT TREATMENT
dc.subject EUROPEAN-SOCIETY
dc.subject MANAGEMENT
dc.subject HOSPITALIZATION
dc.subject THROMBOSIS
dc.subject 3126 Surgery, anesthesiology, intensive care, radiology
dc.subject 3121 General medicine, internal medicine and other clinical medicine
dc.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 en
dc.type Article
dc.contributor.organization HUS Emergency Medicine and Services
dc.contributor.organization Department of Diagnostics and Therapeutics
dc.contributor.organization University of Helsinki
dc.description.reviewstatus Peer reviewed
dc.relation.doi https://doi.org/10.1093/eurheartj/ehz367
dc.relation.issn 0195-668X
dc.rights.accesslevel openAccess
dc.type.version publishedVersion

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