Survival and Quality of Life after Early Discharge in Low-Risk Pulmonary Embolism

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 HarjolaMatthias 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

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
JournalThe European respiratory journal
DOIs
Publication statusE-pub ahead of print - 28 Aug 2020

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