Published: 4 February 2021
Authors: Stefano Barco, Irene Schmidtmann, Walter Ageno, Toni Anušić, Rupert M. Bauersachs, Cecilia Becattini, Enrico Bernardi, Jan Beyer-Westendorf, Luca Bonacchini, Johannes Brachmann, Michael Christ, Michael Czihal, Daniel Duerschmied, Klaus Empen, Christine Espinola-Klein, Joachim H. Ficker, Cândida Fonseca, Sabine Genth-Zotz, David Jiménez, Veli-Pekka Harjola, Matthias Held, Lorenzo Iogna Prat, Tobias J. Lange, Mareike Lankeit, Athanasios Manolis, Andreas Meyer, Thomas Münzel, Pirjo Mustonen, Ursula Rauch-Kroehnert, Pedro Ruiz-Artacho, Sebastian Schellong, Martin Schwaiblmair, Raoul Stahrenberg, Luca Valerio, Peter E. Westerweel, Philipp S. Wild, Stavros V. Konstantinides on behalf of the HoT-PE Investigators
Source: This abstract has been sourced from NZ Respiratory Research Review Issue 183
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.
NZ Respiratory Research Review Issue 183