2021

Barco, S.; Schmidtmann, I.; Ageno, W.; Anusić, T.; Bauersachs, R.M.; Becattini, C.; Bernardi, E.; Beyer-Westendorf, J.; Bonacchini, L.; Brachmann, J.; Christ, M.; Czihal, M.; Duerschmied, D.; Empen, K.; Espinola-Klein, C.; Ficker, J.H.; Fonseca, C.; Genth-Zotz, S.; Jiménez, D.; Harjola, V.; Held, M.; Iogna Prat, L.; Lange, T.J.; Lankeit, M.; Manolis, A.; Meyer, A.; Münzel, T.; Mustonen, P.; Rauch-Kroehnert, U.; Ruiz-Artacho, P.; Schellong, S.; Schwaiblmair, M.; Stahrenberg, R.; Valerio, L.; Westerweel, P.E.; Wild, P.S.; Konstantinides, S.V.

Background: Early discharge of patients with acute low-risk pulmonary embolism (PE) requires validation by prospective trials with clinical and quality of life outcomes. Methods: The multinational Home Treatment of Pulmonary Embolism (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 three-month recurrence (primary outcome) and one-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 PE. Results: The primary efficacy outcome occurred in three (0.5%; upper 95.0% CI 1.3%) patients. One-year mortality was 2.4%. The mean 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. EQ-5D-5L was 0.89±0.12 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, 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 at 3 months (p<0.0001). Conclusions: Our results further support early discharge and ambulatory oral anticoagulation for selected patients with low-risk PE. Targeted strategies may be necessary to further improve quality of life in specific patient subgroups.