Survival and quality of life after early discharge in low-risk pulmonary embolism. Issue 2 (4th February 2021)

• Record Type: Journal Article
• Authors: Barco, Stefano; Schmidtmann, Irene; Ageno, Walter; Anušić, Toni; Bauersachs, Rupert M.; Becattini, Cecilia; Bernardi, Enrico; Beyer-Westendorf, Jan; Bonacchini, Luca; Brachmann, Johannes; Christ, Michael; Czihal, Michael; Duerschmied, Daniel; Empen, Klaus; Espinola-Klein, Christine; Ficker, Joachim H.; Fonseca, Cândida; Genth-Zotz, Sabine; Jiménez, David; Harjola, Veli-Pekka; Held, Matthias; Iogna Prat, Lorenzo; Lange, Tobias J.; Lankeit, Mareike; Manolis, Athanasios; Meyer, Andreas; Münzel, Thomas; Mustonen, Pirjo; Rauch-Kroehnert, Ursula; Ruiz-Artacho, Pedro; Schellong, Sebastian; Schwaiblmair, Martin; Stahrenberg, Raoul; Valerio, Luca; Westerweel, Peter E.; Wild, Philipp S.; Konstantinides, Stavros V.;
• Other Names: author non-byline.; Konstantinides Stavros V. author non-byline.; Bauersachs Rupert Martin author non-byline.; Bode Christoph author non-byline.; Christ Michael author non-byline.; Espinola-Klein Christine author non-byline.; Geibel Annette author non-byline.; Lankeit Mareike author non-byline.; Pfeifer Michael author non-byline.; Schellong Sebastian author non-byline.; Wild Philipp S. author non-byline.; Binder Harald author non-byline.; Valerio Luca author non-byline.; Quitzau Kurt author non-byline.; Martin Nadine author non-byline.; Becker Dorothea author non-byline.; Barco Stefano author non-byline.; Schmidtmann Irene author non-byline.; Anusic Toni author non-byline.; Schwaiblmair Martin author non-byline.; Rauch-Kröhnert Ursula author non-byline.; Möckel Martin author non-byline.; Brachmann Johannes author non-byline.; Beyer-Westendorf Jan author non-byline.; Duerschmied Daniel author non-byline.; Blaschke Sabine author non-byline.; Hoeper Marius M. author non-byline.; Giannitis Evangelos author non-byline.; Empen Klaus author non-byline.; Schmiedel Rainer author non-byline.; Hoffman Ulrich author non-byline.; Akin Ibrahim author non-byline.; Meyer Andreas author non-byline.; Genth-Zotz Sabine author non-byline.; Ficker Joachim author non-byline.; Geisler Tobias author non-byline.; Held Matthias author non-byline.; Becattini Cecilia author non-byline.; Cimini Ludovica author non-byline.; Ageno Walter author non-byline.; Sbrojavacca Rodolfo author non-byline.; Bernardi Enrico author non-byline.; Bettoni Giuseppe author non-byline.; Cosentini Roberto author non-byline.; Moscatelli Paolo author non-byline.; Nitti Cinzia author non-byline.; Pazzaglia Maria author non-byline.; Pesavento Raffaele author non-byline.; Ascani Alessandra author non-byline.; Cortellaro Francesca author non-byline.; Montano Nicola author non-byline.; Westerweel Peter E. author non-byline.; Ruiz-Artacho Pedro author non-byline.; Jiménez David author non-byline.; Ballaz-Quincoces Aitor author non-byline.; Lopez Reyes Raquel author non-byline.; Otero Remedios author non-byline.; Fonseca Candida author non-byline.; Judas Tiago author non-byline.; Araujo Inês author non-byline.; Batista Sergio author non-byline.; Goncalves Fabienne author non-byline.; Harjola Veli-Pekka author non-byline.; Mustonen Pirjo author non-byline.; Hahalis Georgios author non-byline.; Manginas Athanassios author non-byline.; Gougoulianis Konstantinos author non-byline.; Manolis Athanasios author non-byline.; Czihal Michael author non-byline.; Lange Tobias J. author non-byline.; Stahrenberg Raoul author non-byline.; Meinertz Thomas author non-byline.; Menno V. Huisman author non-byline.; Paolo Prandoni author non-byline.; Walter Lehmacher author non-byline.;
• Is Part Of: European respiratory journal. Volume 57:Issue 2(2021)
• Publication Date: 2021-02-04
• Subjects: Respiratory organs -- Diseases -- Periodicals; Respiration -- Periodicals; 616.2
• DOI: 10.1183/13993003.02368-2020
• Languages: English
• ISSNs: 0903-1936

Abstract

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