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
Abstract
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.
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 α = 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%).
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.
Contributors
Irene Schmidtmann
Author
Walter Ageno
Author
Rupert M Bauersachs
Author
Cecilia Becattini
Author
Enrico Bernardi
Author
Jan Beyer-Westendorf
Author
Luca Bonacchini
Author
Johannes Brachmann
Author
Michael Christ
Author
Michael Czihal
Author
Daniel Duerschmied
Author
Klaus Empen
Author
Christine Espinola-Klein
Author
Joachim H Ficker
Author
Cândida Fonseca
Author
Sabine Genth-Zotz
Author
Veli-Pekka Harjola
Author
Matthias Held
Author
Lorenzo Iogna Prat
Author
Tobias J Lange
Author
Athanasios Manolis
Author
Andreas Meyer
Author
Pirjo Mustonen
Author
Ursula Rauch-Kroehnert
Author
Pedro Ruiz-Artacho
Author
Sebastian Schellong
Author
Martin Schwaiblmair
Author
Raoul Stahrenberg
Author
Peter E Westerweel
Author
Philipp S Wild
Author
Stavros V Konstantinides
Author
University Medical Centre of the Johannes Gutenberg University Mainz , Germany
Mareike Lankeit
Author
Stavros V Konstantinides
Author
Rupert Martin Bauersachs
Author
Christoph Bode
Author
Michael Christ
Author
Christine Espinola-Klein
Author
Annette Geibel
Author
Mareike Lankeit
Author
Michael Pfeifer
Author
Sebastian Schellong
Author
Philipp S Wild
Author
Harald Binder
Author
Kurt Quitzau
Author
Nadine Martin
Author
Dorothea Becker
Author
Stefano Barco
Author
Irene Schmidtmann
Author
Toni Anusic
Author
Martin Schwaiblmair
Author
Ursula Rauch-Kröhnert
Author
Martin Möckel
Author
Johannes Brachmann
Author
Jan Beyer-Westendorf
Author
Daniel Duerschmied
Author
Sabine Blaschke
Author
Marius M Hoeper
Author
Evangelos Giannitis
Author
Klaus Empen
Author
Rainer Schmiedel
Author
Ulrich Hoffman
Author
Ibrahim Akin
Author
Andreas Meyer
Author
Sabine Genth-Zotz
Author
Joachim Ficker
Author
Tobias Geisler
Author
Matthias Held
Author
Cecilia Becattini
Author
Ludovica Cimini
Author
Jörg Herold Walter Ageno
Author
Rodolfo Sbrojavacca
Author
Enrico Bernardi
Author
Giuseppe Bettoni
Author
Roberto Cosentini
Author
Paolo Moscatelli
Author
Cinzia Nitti
Author
Maria Pazzaglia
Author
Raffaele Pesavento
Author
Alessandra Ascani
Author
Francesca Cortellaro
Author
Nicola Montano
Author
Peter E Westerweel
Author
Pedro Ruiz-Artacho
Author
David Jiménez
Author
Aitor Ballaz-Quincoces
Author
Raquel Lopez Reyes
Author
Remedios Otero
Author
Candida Fonseca
Author
Tiago Judas
Author
Inês Araujo
Author
Sergio Batista
Author
Fabienne Goncalves
Author
Veli-Pekka Harjola
Author
Pirjo Mustonen
Author
Georgios Hahalis
Author
Athanassios Manginas
Author
Konstantinos Gougoulianis
Author
Athanasios Manolis
Author
Michael Czihal
Author
Tobias J Lange
Author
Raoul Stahrenberg
Author
Thomas Meinertz
Author
Menno V Huisman
Author
Paolo Prandoni
Author
Walter Lehmacher
Author
Stanislav Gorbulev
Author
Kai Kronfeld
Author
