Barco, Stefano and Schmidtmann, Irene and Ageno, Walter and Anusic, Toni 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 Lankeit, Mareike and Manolis, Athanasios and Meyer, Andreas and Muenzel, Thomas and Mustonen, Pirjo and Rauch-Kroehnert, Ursula and Ruiz-Artacho, Pedro and Schellong, Sebastian and Schwaiblmair, Martin and Stahrenberg, Raoul and Valerio, Luca and Westerweel, Peter E. and Wild, Philipp S. and Konstantinides, Stavros V. (2021) Survival and quality of life after early discharge in low-risk pulmonary embolism. EUROPEAN RESPIRATORY JOURNAL, 57 (2): 2002368. ISSN 0903-1936, 1399-3003
Full text not available from this repository. (Request a copy)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 PFmb-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 425 +/- 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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | VENOUS THROMBOEMBOLISM; OUTPATIENT TREATMENT; INPATIENT TREATMENT; ORAL RIVAROXABAN; HOSPITALIZATION; INHIBITOR; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin II |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 04 Oct 2022 09:29 |
| Last Modified: | 04 Oct 2022 09:29 |
| URI: | https://pred.uni-regensburg.de/id/eprint/48211 |
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