Survival and Quality of Life after Early Discharge in Low-Risk Pulmonary Embolism
Stefano Barco 1 2 , Irene Schmidtmann 3 , Walter Ageno 4 , Toni Anušić 3 , Rupert M Bauersachs 5 , Cecilia Becattini 6 , Enrico Bernardi 7 , Jan Beyer-Westendorf 8 9 , Luca Bonacchini 10 , Johannes Brachmann 11 , Michael Christ 12 , Michael Czihal 13 , Daniel Duerschmied 14 , Klaus Empen 15 , Christine Espinola-Klein 16 , Joachim H Ficker 17 , Cândida Fonseca 18 , Sabine Genth-Zotz 19 , David Jiménez 20 , Veli-Pekka Harjola 21 , Matthias Held 22 , Lorenzo Iogna Prat 23 , Tobias J Lange 24 , Mareike Lankeit 1 25 26 , Athanasios Manolis 27 , Andreas Meyer 28 , Thomas Münzel 16 29 , Pirjo Mustonen 30 , Ursula Rauch-Kroehnert 31 32 , Pedro Ruiz-Artacho 33 34 35 36 , Sebastian Schellong 37 , Martin Schwaiblmair 38 , Raoul Stahrenberg 39 , Luca Valerio 1 , Peter E Westerweel 40 , Philipp S Wild 1 29 41 , Stavros V Konstantinides 1 42 , HoT-PE Investigators
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.
CITA DEL ARTÍCULO Eur Respir J . 2020 Aug 28;2002368. doi: 10.1183/13993003.02368-2020