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

Roisin Bavalia, Ingrid M Bistervels, Wim G Boersma, Isabelle Quere, Dominique Brisot, Nicolas Falvo, Dominique Stephan, Francis Couturaud, Sebastian Schellong, Jan Beyer-Westendorf, Karine Montaclair, Waleed Ghanima, Marije Ten Wolde, Michiel Coppens, Emile Ferrari, Olivier Sanchez, Patrick Carroll, Pierre-Marie Roy, Susan R Kahn, Karina Meijer, Simone Birocchi, Michael J Kovacs, Amanda Hugman, Hugo Ten Cate, Hilde Wik, Gilles Pernod, Marie-Antoinette Sevestre-Pietri, Michael A Grosso, Minggao Shi, Yong Lin, Barbara A Hutten, Peter Verhamme, Saskia Middeldorp, Hokusai post‐PE study investigators, Roisin Bavalia, Ingrid M Bistervels, Wim G Boersma, Isabelle Quere, Dominique Brisot, Nicolas Falvo, Dominique Stephan, Francis Couturaud, Sebastian Schellong, Jan Beyer-Westendorf, Karine Montaclair, Waleed Ghanima, Marije Ten Wolde, Michiel Coppens, Emile Ferrari, Olivier Sanchez, Patrick Carroll, Pierre-Marie Roy, Susan R Kahn, Karina Meijer, Simone Birocchi, Michael J Kovacs, Amanda Hugman, Hugo Ten Cate, Hilde Wik, Gilles Pernod, Marie-Antoinette Sevestre-Pietri, Michael A Grosso, Minggao Shi, Yong Lin, Barbara A Hutten, Peter Verhamme, Saskia Middeldorp, Hokusai post‐PE study investigators

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.

Keywords: edoxaban; pulmonary embolism; quality of life; warfarin.

© 2021 The Authors. Research and Practice in Thrombosis and Haemostasis published by Wiley Periodicals LLC on behalf of International Society on Thrombosis and Haemostasis (ISTH).

Figures

FIGURE 1
FIGURE 1
Flowchart of invited participating centers and included patients
FIGURE 2
FIGURE 2
Generic quality of life in patients with pulmonary embolism treated with edoxaban or warfarin. Mean SF‐36 scores of patients with a history of acute pulmonary embolism in patients on edoxaban (n = 129) and warfarin (n = 122), stratified per dimension. SF‐36, 36‐Item Short Form Health Survey
FIGURE 3
FIGURE 3
Mean difference of generic quality of life in patients with pulmonary embolism treated with edoxaban or warfarin. Mean difference and 95% confidence interval; of SF‐36 scores of patients with a history of acute pulmonary embolism in patients on edoxaban (n = 129) and warfarin (n = 122), stratified per dimension. This graph is not corrected for any baseline characteristics. The dotted purple line is the minimal clinically important difference of 10 points as described in the Methods section. SF‐36, 36‐Item Short Form Health Survey
FIGURE 4
FIGURE 4
Pulmonary embolism–specific quality of life in patients with pulmonary embolism treated with edoxaban or warfarin. Results of the PEmb‐QoL scores of patients with a history of acute pulmonary embolism in patients on edoxaban (n = 129) and warfarin (n = 122) Scores are presented as means. Higher PEmb‐QoL scores indicate improved quality of life. PEmb‐QoL, Pulmonary Embolism Quality of Life
FIGURE 5
FIGURE 5
Mean difference of pulmonary embolism–specific quality of life in PE patients treated with edoxaban or warfarin. Mean differences of the six dimensions of the PEmb‐QoL scores in patients with a history of acute pulmonary embolism treated with edoxaban (n = 129) and warfarin (n = 122). Scores are presented as mean differences between both groups with 95% confidence interval. The dotted purple line is the minimal clinically important difference of 15 points as described in the methods section. PEmb‐QoL, Pulmonary Embolism Quality of Life

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