Patient self-management of warfarin therapy – a long-term follow up study

Abstract Background Patient self-management (PSM) of anticoagulant treatment with vitamin K antagonist (VKA) has emerged as an effective approach for maintaining the international normalized ratio (INR) within the therapeutic range. The objective of this quality assurance project, conducted in clini...

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Main Authors: Erland Hegardt Hall, Marit Holm Sølsnes, Sverre Sandberg, Una Ørvim Sølvik
Format: Article
Language:English
Published: BMC 2025-02-01
Series:Thrombosis Journal
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Online Access:https://doi.org/10.1186/s12959-025-00694-z
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author Erland Hegardt Hall
Marit Holm Sølsnes
Sverre Sandberg
Una Ørvim Sølvik
author_facet Erland Hegardt Hall
Marit Holm Sølsnes
Sverre Sandberg
Una Ørvim Sølvik
author_sort Erland Hegardt Hall
collection DOAJ
description Abstract Background Patient self-management (PSM) of anticoagulant treatment with vitamin K antagonist (VKA) has emerged as an effective approach for maintaining the international normalized ratio (INR) within the therapeutic range. The objective of this quality assurance project, conducted in clinical practice, was to evaluate the long-term effectiveness and safety of anticoagulant treatment with warfarin during PSM compared to conventional treatment administered by general practitioners (GPs). Methods This cohort study, using a retrospective and prospective design, included 400 patients who underwent PSM training for a 21-week period between 2011 and 2020. Clinical data extracted from the patient journal systems included hospitalization due to severe clinical complications. The primary outcome was any difference in the yearly risk of hospitalization between the conventional and PSM periods. Secondary outcomes included variations in time within the therapeutic range (TTR), INR fluctuations, and incidence of extreme INR values. Results The median treatment duration was 2.45 years (25th—75th percentile 0.80, 7.35) for the conventional period and 4.99 years (25th—75th percentile 2.41, 7.43) for the PSM period. The annual risk for hospitalization due to severe bleeding was 1.25% during PSM compared to 1.69% during conventional treatment (p = 0.885). The yearly risk for hospitalization due to thrombosis was 0.67% during PSM versus 1.48% during conventional treatment (p = 0.256), and the annual risk for hospitalization due to spontaneous bleeding, thrombosis, or thromboemboli was 1.12% versus 2.76% (p = 0.112). Median TTR (25th—75th percentile) increased from 71.6% (60.0, 82.7) to 78.6% (67.9, 91.7) (p < 0.001), while INR variance decreased from 21.0% to 16.5% (p < 0.001). The proportion of extreme subtherapeutic INR values (≤ 2.0 (≤ 1.5 for patients with mechanical ON-X aortic valve prostheses)) decreased from 14.0% to 5.0% (p < 0.001) during PSM, whereas the proportion of high-level INR (≥ 5.0) remained unchanged (0.6%). Conclusions The long-term evaluation of PSM of warfarin treatment in clinical practice suggests that PSM for suitable patients selected by GPs is as safe as conventional GP treatment.
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spelling doaj-art-ce5aad99cd01435d9263d934dfb51ca02025-08-20T02:25:16ZengBMCThrombosis Journal1477-95602025-02-0123111010.1186/s12959-025-00694-zPatient self-management of warfarin therapy – a long-term follow up studyErland Hegardt Hall0Marit Holm Sølsnes1Sverre Sandberg2Una Ørvim Sølvik3Department of Laboratory Medicine, Nordland Hospital in BodøDepartment of Laboratory Medicine, Nordland Hospital in BodøNorwegian Organization of Quality Improvement of Laboratory Examinations (Noklus), Haraldsplass Deaconess HospitalDepartment of Global Public Health and Primary Care, Faculty of Medicine, University of BergenAbstract Background Patient self-management (PSM) of anticoagulant treatment with vitamin K antagonist (VKA) has emerged as an effective approach for maintaining the international normalized ratio (INR) within the therapeutic range. The objective of this quality assurance project, conducted in clinical practice, was to evaluate the long-term effectiveness and safety of anticoagulant treatment with warfarin during PSM compared to conventional treatment administered by general practitioners (GPs). Methods This cohort study, using a retrospective and prospective design, included 400 patients who underwent PSM training for a 21-week period between 2011 and 2020. Clinical data extracted from the patient journal systems included hospitalization due to severe clinical complications. The primary outcome was any difference in the yearly risk of hospitalization between the conventional and PSM periods. Secondary outcomes included variations in time within the therapeutic range (TTR), INR fluctuations, and incidence of extreme INR values. Results The median treatment duration was 2.45 years (25th—75th percentile 0.80, 7.35) for the conventional period and 4.99 years (25th—75th percentile 2.41, 7.43) for the PSM period. The annual risk for hospitalization due to severe bleeding was 1.25% during PSM compared to 1.69% during conventional treatment (p = 0.885). The yearly risk for hospitalization due to thrombosis was 0.67% during PSM versus 1.48% during conventional treatment (p = 0.256), and the annual risk for hospitalization due to spontaneous bleeding, thrombosis, or thromboemboli was 1.12% versus 2.76% (p = 0.112). Median TTR (25th—75th percentile) increased from 71.6% (60.0, 82.7) to 78.6% (67.9, 91.7) (p < 0.001), while INR variance decreased from 21.0% to 16.5% (p < 0.001). The proportion of extreme subtherapeutic INR values (≤ 2.0 (≤ 1.5 for patients with mechanical ON-X aortic valve prostheses)) decreased from 14.0% to 5.0% (p < 0.001) during PSM, whereas the proportion of high-level INR (≥ 5.0) remained unchanged (0.6%). Conclusions The long-term evaluation of PSM of warfarin treatment in clinical practice suggests that PSM for suitable patients selected by GPs is as safe as conventional GP treatment.https://doi.org/10.1186/s12959-025-00694-zPatient self-managementConventional treatmentAnticoagulation treatmentComplicationsTTRINR variation
spellingShingle Erland Hegardt Hall
Marit Holm Sølsnes
Sverre Sandberg
Una Ørvim Sølvik
Patient self-management of warfarin therapy – a long-term follow up study
Thrombosis Journal
Patient self-management
Conventional treatment
Anticoagulation treatment
Complications
TTR
INR variation
title Patient self-management of warfarin therapy – a long-term follow up study
title_full Patient self-management of warfarin therapy – a long-term follow up study
title_fullStr Patient self-management of warfarin therapy – a long-term follow up study
title_full_unstemmed Patient self-management of warfarin therapy – a long-term follow up study
title_short Patient self-management of warfarin therapy – a long-term follow up study
title_sort patient self management of warfarin therapy a long term follow up study
topic Patient self-management
Conventional treatment
Anticoagulation treatment
Complications
TTR
INR variation
url https://doi.org/10.1186/s12959-025-00694-z
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