RT Journal Article
SR Electronic
T1 Survival and quality of life after early discharge in low-risk pulmonary embolism
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP 2002368
DO 10.1183/13993003.02368-2020
VO 57
IS 2
A1 Stefano Barco
A1 Irene Schmidtmann
A1 Walter Ageno
A1 Toni Anušić
A1 Rupert M. Bauersachs
A1 Cecilia Becattini
A1 Enrico Bernardi
A1 Jan Beyer-Westendorf
A1 Luca Bonacchini
A1 Johannes Brachmann
A1 Michael Christ
A1 Michael Czihal
A1 Daniel Duerschmied
A1 Klaus Empen
A1 Christine Espinola-Klein
A1 Joachim H. Ficker
A1 Cândida Fonseca
A1 Sabine Genth-Zotz
A1 David Jiménez
A1 Veli-Pekka Harjola
A1 Matthias Held
A1 Lorenzo Iogna Prat
A1 Tobias J. Lange
A1 Mareike Lankeit
A1 Athanasios Manolis
A1 Andreas Meyer
A1 Thomas Münzel
A1 Pirjo Mustonen
A1 Ursula Rauch-Kroehnert
A1 Pedro Ruiz-Artacho
A1 Sebastian Schellong
A1 Martin Schwaiblmair
A1 Raoul Stahrenberg
A1 Luca Valerio
A1 Peter E. Westerweel
A1 Philipp S. Wild
A1 Stavros V. Konstantinides
YR 2021
UL http://erj.ersjournals.com/content/57/2/2002368.abstract
AB Introduction Early discharge of patients with acute low-risk pulmonary embolism requires validation by prospective trials with clinical and quality-of-life outcomes.Methods The multinational Home Treatment of Patients with Low-Risk Pulmonary Embolism with the Oral Factor Xa Inhibitor Rivaroxaban (HoT-PE) single-arm management trial investigated early discharge followed by ambulatory treatment with rivaroxaban. The study was stopped for efficacy after the positive results of the predefined interim analysis at 50% of the planned population. The present analysis includes the entire trial population (576 patients). In addition to 3-month recurrence (primary outcome) and 1-year overall mortality, we analysed self-reported disease-specific (Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire) and generic (five-level five-dimension EuroQoL (EQ-5D-5L) scale) quality of life as well as treatment satisfaction (Anti-Clot Treatment Scale (ACTS)) after pulmonary embolism.Results The primary efficacy outcome occurred in three (0.5%, one-sided upper 95% CI 1.3%) patients. The 1-year mortality was 2.4%. The mean±sd PEmb-QoL decreased from 28.9±20.6% at 3 weeks to 19.9±15.4% at 3 months, a mean change (improvement) of −9.1% (p<0.0001). Improvement was consistent across all PEmb-QoL dimensions. The EQ-5D-5L was 0.89±0.12 at 3 weeks after enrolment and improved to 0.91±0.12 at 3 months (p<0.0001). Female sex and cardiopulmonary disease were associated with poorer disease-specific and generic quality of life; older age was associated with faster worsening of generic quality of life. The ACTS burden score improved from 40.5±6.6 points at 3 weeks to 42.5±5.9 points at 3 months (p<0.0001).Conclusions Our results further support early discharge and ambulatory oral anticoagulation for selected patients with low-risk pulmonary embolism. Targeted strategies may be necessary to further improve quality of life in specific patient subgroups.The results of the complete primary outcome analysis of the HoT-PE study, as well as long-term mortality and quality-of-life data, support early discharge and ambulatory oral anticoagulation with rivaroxaban for selected patients with acute low-risk PE https://bit.ly/32qX0mu