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

I.M. Bistervels; R. Bavalia; J. Beyer-Westendorf; A.J. ten Cate-Hoek; S.M. Schellong; M.J. Kovacs; N. Falvo; K. Meijer; D. Stephan; W.G. Boersma; M. ten Wolde; F. Couturaud; P. Verhamme; D. Brisot; S.R. Kahn; W. Ghanima; K. Montaclair; A. Hugman; P. Carroll; G. Pernod; O. Sanchez; E. Ferrari; P.M. Roy; M.A. Sevestre-Pietri; S. Birocchi; H.S. Wik; B.A. Hutten; M. Coppens; C. Naue; M.A. Grosso; M.G. Shi; Y. Lin; I. Quere; S. Middeldorp; Hokusai PTS Investigators

doi:10.1002/rth2.12748

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

I.M. Bistervels^*, R. Bavalia, J. Beyer-Westendorf, A.J. ten Cate-Hoek, S.M. Schellong, M.J. Kovacs, N. Falvo, K. Meijer, D. Stephan, W.G. Boersma, M. ten Wolde, F. Couturaud, P. Verhamme, D. Brisot, S.R. Kahn, W. Ghanima, K. Montaclair, A. Hugman, P. Carroll, G. PernodO. Sanchez, E. Ferrari, P.M. Roy, M.A. Sevestre-Pietri, S. Birocchi, H.S. Wik, B.A. Hutten, M. Coppens, C. Naue, M.A. Grosso, M.G. Shi, Y. Lin, I. Quere, S. Middeldorp, Hokusai PTS Investigators

^*Corresponding author for this work

Carim - Clinical thrombosis and Haemostasis

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

Background Postthrombotic syndrome (PTS) is a long-term complication after deep vein thrombosis (DVT) and can affect quality of life (QoL). Pathogenesis is not fully understood but inadequate anticoagulant therapy with vitamin K antagonists is a known risk factor for the development of PTS. Objectives To compare the prevalence of PTS after acute DVT and the long-term QoL following DVT between patients treated with edoxaban or warfarin. Methods We performed a long-term follow-up study in a subset of patients with DVT who participated in the Hokusai-VTE trial between 2010 and 2012 (NCT00986154). Primary outcome was the prevalence of PTS, defined by the Villalta score. The secondary outcome was QoL, assessed by validated disease-specific (VEINES-QOL) and generic health-related (SF-36) questionnaires. Results Between 2017 and 2020, 316 patients were enrolled in 26 centers in eight countries, of which 168 (53%) patients had been assigned to edoxaban and 148 (47%) to warfarin during the Hokusai-VTE trial. Clinical, demographic, and thrombus-specific characteristics were comparable for both groups. Mean (SD) time since randomization in the Hokusai-VTE trial was 7.0 (1.0) years. PTS was diagnosed in 85 (51%) patients treated with edoxaban and 62 (42%) patients treated with warfarin (adjusted odds ratio 1.6, 95% CI 1.0-2.6). Mean differences in QoL scores between treatment groups were not clinically relevant. Conclusion Contrary to our hypothesis, the prevalence of PTS tended to be higher in patients treated with edoxaban compared with warfarin. No differences in QoL were observed. Further research is warranted to unravel the role of anticoagulant therapy on development of PTS.

Original language	English
Article number	e12748
Number of pages	13
Journal	Research and practice in thrombosis and haemostasis
Volume	6
Issue number	5
DOIs	https://doi.org/10.1002/rth2.12748
Publication status	Published - 1 Jul 2022

Keywords

edoxaban
postthrombotic syndrome
quality of life
venous thrombosis
warfarin
CATHETER-DIRECTED THROMBOLYSIS
COMPRESSION STOCKINGS
VENOUS THROMBOSIS
QOL/SYM QUESTIONNAIRE
K ANTAGONISTS
RIVAROXABAN
PREVENTION
THROMBOEMBOLISM
COMPLICATIONS
SF-36

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Bistervels, I. M., Bavalia, R., Beyer-Westendorf, J., ten Cate-Hoek, A. J., Schellong, S. M., Kovacs, M. J., Falvo, N., Meijer, K., Stephan, D., Boersma, W. G., ten Wolde, M., Couturaud, F., Verhamme, P., Brisot, D., Kahn, S. R., Ghanima, W., Montaclair, K., Hugman, A., Carroll, P., ... Hokusai PTS Investigators (2022). Postthrombotic syndrome and quality of life after deep vein thrombosis in patients treated with edoxaban versus warfarin. Research and practice in thrombosis and haemostasis, 6(5), Article e12748. https://doi.org/10.1002/rth2.12748

@article{918b852ff1d949a6bfeaf8324a2665be,

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

abstract = "Background Postthrombotic syndrome (PTS) is a long-term complication after deep vein thrombosis (DVT) and can affect quality of life (QoL). Pathogenesis is not fully understood but inadequate anticoagulant therapy with vitamin K antagonists is a known risk factor for the development of PTS. Objectives To compare the prevalence of PTS after acute DVT and the long-term QoL following DVT between patients treated with edoxaban or warfarin. Methods We performed a long-term follow-up study in a subset of patients with DVT who participated in the Hokusai-VTE trial between 2010 and 2012 (NCT00986154). Primary outcome was the prevalence of PTS, defined by the Villalta score. The secondary outcome was QoL, assessed by validated disease-specific (VEINES-QOL) and generic health-related (SF-36) questionnaires. Results Between 2017 and 2020, 316 patients were enrolled in 26 centers in eight countries, of which 168 (53%) patients had been assigned to edoxaban and 148 (47%) to warfarin during the Hokusai-VTE trial. Clinical, demographic, and thrombus-specific characteristics were comparable for both groups. Mean (SD) time since randomization in the Hokusai-VTE trial was 7.0 (1.0) years. PTS was diagnosed in 85 (51%) patients treated with edoxaban and 62 (42%) patients treated with warfarin (adjusted odds ratio 1.6, 95% CI 1.0-2.6). Mean differences in QoL scores between treatment groups were not clinically relevant. Conclusion Contrary to our hypothesis, the prevalence of PTS tended to be higher in patients treated with edoxaban compared with warfarin. No differences in QoL were observed. Further research is warranted to unravel the role of anticoagulant therapy on development of PTS.",

keywords = "edoxaban, postthrombotic syndrome, quality of life, venous thrombosis, warfarin, CATHETER-DIRECTED THROMBOLYSIS, COMPRESSION STOCKINGS, VENOUS THROMBOSIS, QOL/SYM QUESTIONNAIRE, K ANTAGONISTS, RIVAROXABAN, PREVENTION, THROMBOEMBOLISM, COMPLICATIONS, SF-36",

author = "I.M. Bistervels and R. Bavalia and J. Beyer-Westendorf and {ten Cate-Hoek}, A.J. and S.M. Schellong and M.J. Kovacs and N. Falvo and K. Meijer and D. Stephan and W.G. Boersma and {ten Wolde}, M. and F. Couturaud and P. Verhamme and D. Brisot and S.R. Kahn and W. Ghanima and K. Montaclair and A. Hugman and P. Carroll and G. Pernod and O. Sanchez and E. Ferrari and P.M. Roy and M.A. Sevestre-Pietri and S. Birocchi and H.S. Wik and B.A. Hutten and M. Coppens and C. Naue and M.A. Grosso and M.G. Shi and Y. Lin and I. Quere and S. Middeldorp and {Hokusai PTS Investigators}",

note = "Funding Information: We thank all participating patients and study staff and nurses who contributed to this study. A special thanks to Whitney Cheung and Pythia Nieuwkerk (Amsterdam UMC, University of Amsterdam, the Netherlands) for their help in protocol preparation and analyses. Funding Information: J.B.W. reports personal fees and other from Bayer HealthCare, personal fees and other from Boehringer. Ingelheim, personal fees and other from BMS/Pfizer, personal fees and other from CSL Behring, personal fees and other personal fees and other from Daiichi Sankyo, personal fees and other from LEO Pharma, outside the submitted work. F.C. reports grants from BMS/Pfizer, personal fees and other from Bayer HealthCare, personal fees and other from AstraZeneka, personal fees and other from MSD, personal fees and other from GSK, other from Janssen, personal fees and other from Novartis, outside the submitted work. M.C. reports personal fees from Bayer HealthCare, personal fees from Boehringer Ingelheim, personal fees from Bristol‐Myers Squib, personal fees from CSL Behring, personal fees from Daiichi Sankyo, personal fees from Pfizer, personal fees from Portola, personal fees from Sanquin Blood Supply, outside the submitted work. W.G. reports grants and other from Bayer HealthCare, grants and other from Pfizer, other from Novartis, other from Amgen, other from Principia, from Sanofi, other from MSD, other from Sobi, outside the submitted work. K. Meijer receives other from Bayer HealthCare, other from Uniqure, other from Alexion, other from Octapharma, outside the submitted work. S.M. reports grants from GSK, grants from BMS/Pfizer, grants from Aspen, grants from Daiichi Sankyo, grants from Bayer HealthCare, grants from Boehringer Ingelheim, grants from Sanofi, grants from Portola, outside the submitted work. M.A.S.P. reports honoraria from Bayer, Pfizer, and Leo Pharma. O.S. reports grants from Daiichi‐Sankyo, during the conduct of the study; grants, personal fees, and nonfinancial support from Bayer HealthCare, grants, personal fees and nonfinancial support from BMS, personal fees and non‐financial support from Pfizer, grants, personal fees and non‐financial support from Boehringer Ingelheim, grants and personal fees from MSD, personal fees from Chiesi, grants and personal fees from Boston Scientifics, outside the submitted work. S.M.S. reports receiving consulting fees from Bayer and Boehringer Ingelheim, and lecture fees from Bayer, Boehringer Ingelheim, and Bristol‐Myers Squibb–Pfizer. P.V. reports grants and personal fees from Bayer HealthCare, grants and personal fees from Boehringer Ingelheim, grants and personal fees from BMS/Pfizer, personal fees from Daiichi Sankyo, personal fees from LEO Pharma, personal fees from Anthos therapeutics, personal fees from Portola Pharmaceuticals/Alexion, outside the submitted work. M.G., M.S., and Y.L. report being an employee of Daiichi‐Sankyo. No other potential conflict of interest with relation to this study were reported. Publisher Copyright: {\textcopyright} 2022 The Authors. Research and Practice in Thrombosis and Haemostasis published by Wiley Periodicals LLC on behalf of International Society on Thrombosis and Haemostasis (ISTH).",

year = "2022",

month = jul,

day = "1",

doi = "10.1002/rth2.12748",

language = "English",

volume = "6",

journal = "Research and practice in thrombosis and haemostasis",

issn = "2475-0379",

publisher = "Wiley",

number = "5",

}

Bistervels, IM, Bavalia, R, Beyer-Westendorf, J, ten Cate-Hoek, AJ, Schellong, SM, Kovacs, MJ, Falvo, N, Meijer, K, Stephan, D, Boersma, WG, ten Wolde, M, Couturaud, F, Verhamme, P, Brisot, D, Kahn, SR, Ghanima, W, Montaclair, K, Hugman, A, Carroll, P, Pernod, G, Sanchez, O, Ferrari, E, Roy, PM, Sevestre-Pietri, MA, Birocchi, S, Wik, HS, Hutten, BA, Coppens, M, Naue, C, Grosso, MA, Shi, MG, Lin, Y, Quere, I, Middeldorp, S & Hokusai PTS Investigators 2022, 'Postthrombotic syndrome and quality of life after deep vein thrombosis in patients treated with edoxaban versus warfarin', Research and practice in thrombosis and haemostasis, vol. 6, no. 5, e12748. https://doi.org/10.1002/rth2.12748

TY - JOUR

T1 - Postthrombotic syndrome and quality of life after deep vein thrombosis in patients treated with edoxaban versus warfarin

AU - Bistervels, I.M.

AU - Bavalia, R.

AU - Beyer-Westendorf, J.

AU - ten Cate-Hoek, A.J.

AU - Schellong, S.M.

AU - Kovacs, M.J.

AU - Falvo, N.

AU - Meijer, K.

AU - Stephan, D.

AU - Boersma, W.G.

AU - ten Wolde, M.

AU - Couturaud, F.

AU - Verhamme, P.

AU - Brisot, D.

AU - Kahn, S.R.

AU - Ghanima, W.

AU - Montaclair, K.

AU - Hugman, A.

AU - Carroll, P.

AU - Pernod, G.

AU - Sanchez, O.

AU - Ferrari, E.

AU - Roy, P.M.

AU - Sevestre-Pietri, M.A.

AU - Birocchi, S.

AU - Wik, H.S.

AU - Hutten, B.A.

AU - Coppens, M.

AU - Naue, C.

AU - Grosso, M.A.

AU - Shi, M.G.

AU - Lin, Y.

AU - Quere, I.

AU - Middeldorp, S.

AU - Hokusai PTS Investigators

N1 - Funding Information: We thank all participating patients and study staff and nurses who contributed to this study. A special thanks to Whitney Cheung and Pythia Nieuwkerk (Amsterdam UMC, University of Amsterdam, the Netherlands) for their help in protocol preparation and analyses. Funding Information: J.B.W. reports personal fees and other from Bayer HealthCare, personal fees and other from Boehringer. Ingelheim, personal fees and other from BMS/Pfizer, personal fees and other from CSL Behring, personal fees and other personal fees and other from Daiichi Sankyo, personal fees and other from LEO Pharma, outside the submitted work. F.C. reports grants from BMS/Pfizer, personal fees and other from Bayer HealthCare, personal fees and other from AstraZeneka, personal fees and other from MSD, personal fees and other from GSK, other from Janssen, personal fees and other from Novartis, outside the submitted work. M.C. reports personal fees from Bayer HealthCare, personal fees from Boehringer Ingelheim, personal fees from Bristol‐Myers Squib, personal fees from CSL Behring, personal fees from Daiichi Sankyo, personal fees from Pfizer, personal fees from Portola, personal fees from Sanquin Blood Supply, outside the submitted work. W.G. reports grants and other from Bayer HealthCare, grants and other from Pfizer, other from Novartis, other from Amgen, other from Principia, from Sanofi, other from MSD, other from Sobi, outside the submitted work. K. Meijer receives other from Bayer HealthCare, other from Uniqure, other from Alexion, other from Octapharma, outside the submitted work. S.M. reports grants from GSK, grants from BMS/Pfizer, grants from Aspen, grants from Daiichi Sankyo, grants from Bayer HealthCare, grants from Boehringer Ingelheim, grants from Sanofi, grants from Portola, outside the submitted work. M.A.S.P. reports honoraria from Bayer, Pfizer, and Leo Pharma. O.S. reports grants from Daiichi‐Sankyo, during the conduct of the study; grants, personal fees, and nonfinancial support from Bayer HealthCare, grants, personal fees and nonfinancial support from BMS, personal fees and non‐financial support from Pfizer, grants, personal fees and non‐financial support from Boehringer Ingelheim, grants and personal fees from MSD, personal fees from Chiesi, grants and personal fees from Boston Scientifics, outside the submitted work. S.M.S. reports receiving consulting fees from Bayer and Boehringer Ingelheim, and lecture fees from Bayer, Boehringer Ingelheim, and Bristol‐Myers Squibb–Pfizer. P.V. reports grants and personal fees from Bayer HealthCare, grants and personal fees from Boehringer Ingelheim, grants and personal fees from BMS/Pfizer, personal fees from Daiichi Sankyo, personal fees from LEO Pharma, personal fees from Anthos therapeutics, personal fees from Portola Pharmaceuticals/Alexion, outside the submitted work. M.G., M.S., and Y.L. report being an employee of Daiichi‐Sankyo. No other potential conflict of interest with relation to this study were reported. Publisher Copyright: © 2022 The Authors. Research and Practice in Thrombosis and Haemostasis published by Wiley Periodicals LLC on behalf of International Society on Thrombosis and Haemostasis (ISTH).

PY - 2022/7/1

Y1 - 2022/7/1

N2 - Background Postthrombotic syndrome (PTS) is a long-term complication after deep vein thrombosis (DVT) and can affect quality of life (QoL). Pathogenesis is not fully understood but inadequate anticoagulant therapy with vitamin K antagonists is a known risk factor for the development of PTS. Objectives To compare the prevalence of PTS after acute DVT and the long-term QoL following DVT between patients treated with edoxaban or warfarin. Methods We performed a long-term follow-up study in a subset of patients with DVT who participated in the Hokusai-VTE trial between 2010 and 2012 (NCT00986154). Primary outcome was the prevalence of PTS, defined by the Villalta score. The secondary outcome was QoL, assessed by validated disease-specific (VEINES-QOL) and generic health-related (SF-36) questionnaires. Results Between 2017 and 2020, 316 patients were enrolled in 26 centers in eight countries, of which 168 (53%) patients had been assigned to edoxaban and 148 (47%) to warfarin during the Hokusai-VTE trial. Clinical, demographic, and thrombus-specific characteristics were comparable for both groups. Mean (SD) time since randomization in the Hokusai-VTE trial was 7.0 (1.0) years. PTS was diagnosed in 85 (51%) patients treated with edoxaban and 62 (42%) patients treated with warfarin (adjusted odds ratio 1.6, 95% CI 1.0-2.6). Mean differences in QoL scores between treatment groups were not clinically relevant. Conclusion Contrary to our hypothesis, the prevalence of PTS tended to be higher in patients treated with edoxaban compared with warfarin. No differences in QoL were observed. Further research is warranted to unravel the role of anticoagulant therapy on development of PTS.

AB - Background Postthrombotic syndrome (PTS) is a long-term complication after deep vein thrombosis (DVT) and can affect quality of life (QoL). Pathogenesis is not fully understood but inadequate anticoagulant therapy with vitamin K antagonists is a known risk factor for the development of PTS. Objectives To compare the prevalence of PTS after acute DVT and the long-term QoL following DVT between patients treated with edoxaban or warfarin. Methods We performed a long-term follow-up study in a subset of patients with DVT who participated in the Hokusai-VTE trial between 2010 and 2012 (NCT00986154). Primary outcome was the prevalence of PTS, defined by the Villalta score. The secondary outcome was QoL, assessed by validated disease-specific (VEINES-QOL) and generic health-related (SF-36) questionnaires. Results Between 2017 and 2020, 316 patients were enrolled in 26 centers in eight countries, of which 168 (53%) patients had been assigned to edoxaban and 148 (47%) to warfarin during the Hokusai-VTE trial. Clinical, demographic, and thrombus-specific characteristics were comparable for both groups. Mean (SD) time since randomization in the Hokusai-VTE trial was 7.0 (1.0) years. PTS was diagnosed in 85 (51%) patients treated with edoxaban and 62 (42%) patients treated with warfarin (adjusted odds ratio 1.6, 95% CI 1.0-2.6). Mean differences in QoL scores between treatment groups were not clinically relevant. Conclusion Contrary to our hypothesis, the prevalence of PTS tended to be higher in patients treated with edoxaban compared with warfarin. No differences in QoL were observed. Further research is warranted to unravel the role of anticoagulant therapy on development of PTS.

KW - edoxaban

KW - postthrombotic syndrome

KW - quality of life

KW - venous thrombosis

KW - warfarin

KW - CATHETER-DIRECTED THROMBOLYSIS

KW - COMPRESSION STOCKINGS

KW - VENOUS THROMBOSIS

KW - QOL/SYM QUESTIONNAIRE

KW - K ANTAGONISTS

KW - RIVAROXABAN

KW - PREVENTION

KW - THROMBOEMBOLISM

KW - COMPLICATIONS

KW - SF-36

U2 - 10.1002/rth2.12748

DO - 10.1002/rth2.12748

M3 - Article

C2 - 35992565

SN - 2475-0379

VL - 6

JO - Research and practice in thrombosis and haemostasis

JF - Research and practice in thrombosis and haemostasis

IS - 5

M1 - e12748

ER -