Barco, Stefano and Schmidtmann, Irene and Ageno, Walter and Bauersachs, Rupert M. and Becattini, Cecilia and Bernardi, Enrico and Beyer-Westendorf, Jan and Bonacchini, Luca and Brachmann, Johannes and Christ, Michael and Czihal, Michael and Duerschmied, Daniel and Empen, Klaus and Espinola-Klein, Christine and Ficker, Joachim H. and Fonseca, Candida and Genth-Zotz, Sabine and Jimenez, David and Harjola, Veli-Pekka and Held, Matthias and Prat, Lorenzo Iogna and Lange, Tobias J. and Manolis, Athanasios and Meyer, Andreas and Mustonen, Pirjo and Rauch-Kroehnert, Ursula and Ruiz-Artacho, Pedro and Schellong, Sebastian and Schwaiblmair, Martin and Stahrenberg, Raoul and Westerweel, Peter E. and Wild, Philipp S. and Konstantinides, Stavros and Lankeit, Mareike (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, 41 (4). pp. 509-518. ISSN 0195-668X, 1522-9645
Full text not available from this repository. (Request a copy)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 (<6 primary outcome events). From May 2014 through June 2018, consecutive patients were enrolled in seven countries. Of the 525 patients included in the interim analysis, three (0.6%; one-sided upper 99.6% confidence interval 2.1%) suffered symptomatic non-fatal VTE recurrence, a number sufficiently low to fulfil the condition for early termination of the trial. Major bleeding occurred in 6 (1.2%) of the 519 patients comprising the safety population. There were two cancer-related deaths (0.4%). 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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | OUTPATIENT TREATMENT; INPATIENT TREATMENT; EUROPEAN-SOCIETY; MANAGEMENT; HOSPITALIZATION; THROMBOSIS; Pulmonary embolism; Home treatment; Right ventricular dysfunction; Management trial; Rivaroxaban; Risk stratification |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin II |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 01 Apr 2021 10:28 |
| Last Modified: | 01 Apr 2021 10:28 |
| URI: | https://pred.uni-regensburg.de/id/eprint/45330 |
Actions (login required)
 |
View Item |
