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

Lähdeviite

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

Julkaisun nimi: 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
Tekijä: HoT-PE Investigators; Barco, Stefano; Schmidtmann, Irene; Ageno, Walter; Harjola, Veli-Pekka; Lankeit, Mareike
Tekijän organisaatio: HUS Emergency Medicine and Services
Department of Diagnostics and Therapeutics
University of Helsinki
Päiväys: 2020-01-21
Kieli: eng
Sivumäärä: 10
Kuuluu julkaisusarjaan: European Heart Journal
ISSN: 0195-668X
DOI-tunniste: https://doi.org/10.1093/eurheartj/ehz367
URI: http://hdl.handle.net/10138/314238
Tiivistelmä: 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.
Avainsanat: 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
Vertaisarvioitu: Kyllä
Tekijänoikeustiedot: cc_by_nc
Pääsyrajoitteet: openAccess
Rinnakkaistallennettu versio: publishedVersion


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