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RESEARCH PRODUCT
Survival and quality of life after early discharge in low-risk pulmonary embolism.
Michael CzihalPhilipp S. WildLuca ValerioRupert BauersachsCecilia BecattiniIrene SchmidtmannRaoul StahrenbergVeli-pekka HarjolaTobias J. LangePeter E. WesterweelMichael ChristStavros KonstantinidesStavros KonstantinidesDaniel DuerschmiedChristine Espinola-kleinMatthias HeldDavid JiménezPirjo MustonenSabine Genth-zotzLorenzo Iogna PratRuiz-artacho PedroEnrico BernardiJan Beyer-westendorfAthanasios J. ManolisAndreas MeyerCândida FonsecaToni AnusicU Rauch-kroehnertThomas MünzelMartin SchwaiblmairJohannes BrachmannJoachim H. FickerMareike LankeitMareike LankeitMareike LankeitLuca BonacchiniBarco StefanoStefano BarcoSebastian SchellongWalter AgenoKlaus Empensubject
Pulmonary and Respiratory Medicinemedicine.medical_specialtyPopulationPatient subgroups030204 cardiovascular system & hematology03 medical and health sciences0302 clinical medicineQuality of lifeInternal medicineSurveys and QuestionnairesMedicineHumansProspective StudieseducationEarly dischargeAgededucation.field_of_studyRivaroxabanbusiness.industrymedicine.diseaseInterim analysisPatient Discharge3. Good healthPulmonary embolism030228 respiratory systemAmbulatoryQuality of LifeFemalebusinessPulmonary Embolismmedicine.drugdescription
IntroductionEarly discharge of patients with acute low-risk pulmonary embolism requires validation by prospective trials with clinical and quality-of-life outcomes.MethodsThe 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.ResultsThe 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±sdPEmb-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).ConclusionsOur 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.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2020-01-01 | The European respiratory journal |