Survival and quality of life after early discharge in low-risk pulmonary embolism
Stefano Barco, Irene Schmidtmann, Walter Ageno, Toni Anušić, Rupert 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 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 Konstantinides
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.