Quality of life in patients with pulmonary embolism treated with edoxaban versus warfarin

Abstract

Background Long‐term sequelae of acute pulmonary embolism (PE) include decreased quality of life (QoL). Evidence suggests that adequacy of initial anticoagulant treatment in the acute phase of venous thrombosis has a key impact on late postthrombotic complications. We hypothesize that patients with acute PE treated with edoxaban for acute PE experience have improved QoL compared to those treated with warfarin. Methods Patients with PE who participated in the Hokusai‐VTE trial were contacted between June 2017 and September 2020 for a single long‐term follow‐up visit. Main outcomes were the generic and disease‐specific QoL measured by the 36‐Item Short Form Health Survey (SF‐36) and Pulmonary Embolism Quality of Life questionnaire. Results We included 251 patients from 26 centers in eight countries, of which 129 (51%) had been assigned to edoxaban and 122 (49%) to warfarin. Patient‐ and thrombus‐specific characteristics were similar in both groups. Mean time since randomization in the Hokusai‐VTE trial was 7.0 years (standard deviation, 1.0). No relevant or statistical differences were observed in the QoL for patients treated with edoxaban compared to patients treated with warfarin. The mean difference between patients treated with edoxaban and patients with PE treated with warfarin was 0.8 (95% confidence interval [CI]. −1.6 to 3.2) for the SF‐36 summary mental score and 1.6 (95% CI, −0.9 to 4.1) for summary physical score. Conclusion Our findings indicate that patients with an index PE treated with edoxaban or warfarin have a similar long‐term QoL. Since our study was a follow‐up study from a well‐controlled clinical trial setting, future studies should be designed in a daily clinical practice setting. We suggest a longitudinal design for investigation of changes in QoL over time.

Edoxaban in cardiovascular medicine from scientific evidence to clinical practice

“…In 2021, Bavalia et al published the quality of life results of 251 patients treated with edoxaban or warfarin for PE in the Hokusai-VTE trial at 7 years after randomization. In this single visit study, the authors observed no difference in QoL between the two groups based on the 36-item Short Form Health Questionnaire (SF-36) and Pulmonary Embolism Quality of Life Questionnaire (PEMB-QOL) scores [74].…”

Postthrombotic syndrome and quality of life after deep vein thrombosis in patients treated with edoxaban versus warfarin

“…We previously reported the methods and findings of the Hokusai post‐PE study. 38 In short, in 2016, we approached 78 study centers, based on the number of patients included in the original Hokusai‐VTE trial (>10 patients) and language, and located in Austria, Australia, Belgium, Canada, Denmark, France, Germany, Italy, the Netherlands, New Zealand, Norway, United Kingdom, and United States of America to participate in the Hokusai post‐VTE study. Patients were eligible for the current follow‐up study if they were recruited in one of these study centers and treated for DVT (with or without PE) as their index event for participation in the Hokusai‐VTE trial.…”

“…Statistical analysis was conducted according to the statistical analysis plan for the Hokusai post‐VTE studies and therefore similar to the Hokusai post‐PE study 38 . Differences in baseline characteristics between both groups were evaluated by means of the 2‐sample t tests for normally distributed variables and the Mann–Whitney test for skewed distributions; χ 2 tests were applied for categorical data.…”

“…The present Hokusai PTS study is part of the Hokusai post‐VTE study, which is dedicated to assessing long‐term outcomes (NCT04007653). We previously reported the methods and findings of the Hokusai post‐PE study 38 . In short, in 2016, we approached 78 study centers, based on the number of patients included in the original Hokusai‐VTE trial (>10 patients) and language, and located in Austria, Australia, Belgium, Canada, Denmark, France, Germany, Italy, the Netherlands, New Zealand, Norway, United Kingdom, and United States of America to participate in the Hokusai post‐VTE study.…”