Hokusai Post-Pe Study: A Follow-Up Study On Long-Term Outcomes Of Pulmonary Embolism In Patients Treated With Edoxaban Vs Warfarin

Background: Post-pulmonary embolism (Post-PE) syndrome, comprising persistent dyspnea, impaired exercise capacity and chronic thromboembolic pulmonary hypertension, is a long-term complication of pulmonary embolism (PE). Post-PE syndrome is associated with decreased quality of life (QoL) and prevention is of great importance. Direct oral anticoagulants (DOACs) have a more stable pharmacologic profile than vitamin K antagonists (VKA) and may lead to improved thrombus resolution. We therefore hypothesized that treatment of PE with edoxaban compared to VKA (both preceded by heparin), would lead to an improved long-term QoL of PE patients. Aim: To assess long-term generic and PE-specific QoL following PE, in patients treated with edoxaban vs. warfarin. Methods: This is a follow-up study of the original HOKUSAI VTE trial (NCT00986154) and we are collecting data from previously enrolled patients at least 5 years after the index PE. The primary outcome is the QoL, generated by the validated generic (SF-36) and PE-specific (PEmb-QoL) questionnaire. We will compare QoL between both treatment arms. Ethical approval was granted in all participating centers and patients signed informed consent. Results: Up to now, 24 of 76 (32%) of the centers that were invited managed to participate and we have currently included 245 patients. The analyses will be performed after completion of data collection (May 2020). Summary: So far, we have included 245 patients. Inclusions will continue until May 2020 and at the ERS 2020 we will be able to present our results on QoL after PE in patients treated with edoxaban compared to patients treated with warfarin.