Survival and quality of life after early discharge in low-risk pulmonary embolism

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.

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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.

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