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SAIL study of stroke, systemic embolism and bleeding outcomes with warfarin anticoagulation in non-valvular atrial fibrillation (S(4)-BOW-AF)

AIMS: In patients with non-valvular atrial fibrillation (NVAF) prescribed warfarin, the association between guideline defined international normalised ratio (INR) control and adverse outcomes in unknown. We aimed to (i) determine stroke and systemic embolism (SSE) and bleeding events in NVAF patient...

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Autores principales: Harris, Daniel E, Torabi, Fatemeh, Mallory, Daniel, Akbari, Ashley, Thayer, Daniel, Wang, Ting, Grundy, Sarah, Gravenor, Mike, Alikhan, Raza, Lister, Steven, Halcox, Julian
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10153743/
https://www.ncbi.nlm.nih.gov/pubmed/37143610
http://dx.doi.org/10.1093/ehjopen/oead037
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author Harris, Daniel E
Torabi, Fatemeh
Mallory, Daniel
Akbari, Ashley
Thayer, Daniel
Wang, Ting
Grundy, Sarah
Gravenor, Mike
Alikhan, Raza
Lister, Steven
Halcox, Julian
author_facet Harris, Daniel E
Torabi, Fatemeh
Mallory, Daniel
Akbari, Ashley
Thayer, Daniel
Wang, Ting
Grundy, Sarah
Gravenor, Mike
Alikhan, Raza
Lister, Steven
Halcox, Julian
author_sort Harris, Daniel E
collection PubMed
description AIMS: In patients with non-valvular atrial fibrillation (NVAF) prescribed warfarin, the association between guideline defined international normalised ratio (INR) control and adverse outcomes in unknown. We aimed to (i) determine stroke and systemic embolism (SSE) and bleeding events in NVAF patients prescribed warfarin; and (ii) estimate the increased risk of these adverse events associated with poor INR control in this population. METHODS AND RESULTS: Individual-level population-scale linked patient data were used to investigate the association between INR control and both SSE and bleeding events using (i) the National Institute for Health and Care Excellence (NICE) criteria of poor INR control [time in therapeutic range (TTR) <65%, two INRs <1.5 or two INRs >5 in a 6-month period or any INR >8]. A total of 35 891 patients were included for SSE and 35 035 for bleeding outcome analyses. Mean CHA(2)DS(2)-VASc score was 3.5 (SD = 1.7), and the mean follow up was 4.3 years for both analyses. Mean TTR was 71.9%, with 34% of time spent in poor INR control according to NICE criteria. SSE and bleeding event rates (per 100 patient years) were 1.01 (95%CI 0.95–1.08) and 3.4 (95%CI 3.3–3.5), respectively, during adequate INR control, rising to 1.82 (95%CI 1.70–1.94) and 4.8 (95% CI 4.6–5.0) during poor INR control. Poor INR control was independently associated with increased risk of both SSE [HR = 1.69 (95%CI = 1.54–1.86), P < 0.001] and bleeding [HR = 1.40 (95%CI 1.33–1.48), P < 0.001] in Cox-multivariable models. CONCLUSION: Guideline-defined poor INR control is associated with significantly higher SSE and bleeding event rates, independent of recognised risk factors for stroke or bleeding.
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spelling pubmed-101537432023-05-03 SAIL study of stroke, systemic embolism and bleeding outcomes with warfarin anticoagulation in non-valvular atrial fibrillation (S(4)-BOW-AF) Harris, Daniel E Torabi, Fatemeh Mallory, Daniel Akbari, Ashley Thayer, Daniel Wang, Ting Grundy, Sarah Gravenor, Mike Alikhan, Raza Lister, Steven Halcox, Julian Eur Heart J Open Original Article AIMS: In patients with non-valvular atrial fibrillation (NVAF) prescribed warfarin, the association between guideline defined international normalised ratio (INR) control and adverse outcomes in unknown. We aimed to (i) determine stroke and systemic embolism (SSE) and bleeding events in NVAF patients prescribed warfarin; and (ii) estimate the increased risk of these adverse events associated with poor INR control in this population. METHODS AND RESULTS: Individual-level population-scale linked patient data were used to investigate the association between INR control and both SSE and bleeding events using (i) the National Institute for Health and Care Excellence (NICE) criteria of poor INR control [time in therapeutic range (TTR) <65%, two INRs <1.5 or two INRs >5 in a 6-month period or any INR >8]. A total of 35 891 patients were included for SSE and 35 035 for bleeding outcome analyses. Mean CHA(2)DS(2)-VASc score was 3.5 (SD = 1.7), and the mean follow up was 4.3 years for both analyses. Mean TTR was 71.9%, with 34% of time spent in poor INR control according to NICE criteria. SSE and bleeding event rates (per 100 patient years) were 1.01 (95%CI 0.95–1.08) and 3.4 (95%CI 3.3–3.5), respectively, during adequate INR control, rising to 1.82 (95%CI 1.70–1.94) and 4.8 (95% CI 4.6–5.0) during poor INR control. Poor INR control was independently associated with increased risk of both SSE [HR = 1.69 (95%CI = 1.54–1.86), P < 0.001] and bleeding [HR = 1.40 (95%CI 1.33–1.48), P < 0.001] in Cox-multivariable models. CONCLUSION: Guideline-defined poor INR control is associated with significantly higher SSE and bleeding event rates, independent of recognised risk factors for stroke or bleeding. Oxford University Press 2023-04-13 /pmc/articles/PMC10153743/ /pubmed/37143610 http://dx.doi.org/10.1093/ehjopen/oead037 Text en © The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Article
Harris, Daniel E
Torabi, Fatemeh
Mallory, Daniel
Akbari, Ashley
Thayer, Daniel
Wang, Ting
Grundy, Sarah
Gravenor, Mike
Alikhan, Raza
Lister, Steven
Halcox, Julian
SAIL study of stroke, systemic embolism and bleeding outcomes with warfarin anticoagulation in non-valvular atrial fibrillation (S(4)-BOW-AF)
title SAIL study of stroke, systemic embolism and bleeding outcomes with warfarin anticoagulation in non-valvular atrial fibrillation (S(4)-BOW-AF)
title_full SAIL study of stroke, systemic embolism and bleeding outcomes with warfarin anticoagulation in non-valvular atrial fibrillation (S(4)-BOW-AF)
title_fullStr SAIL study of stroke, systemic embolism and bleeding outcomes with warfarin anticoagulation in non-valvular atrial fibrillation (S(4)-BOW-AF)
title_full_unstemmed SAIL study of stroke, systemic embolism and bleeding outcomes with warfarin anticoagulation in non-valvular atrial fibrillation (S(4)-BOW-AF)
title_short SAIL study of stroke, systemic embolism and bleeding outcomes with warfarin anticoagulation in non-valvular atrial fibrillation (S(4)-BOW-AF)
title_sort sail study of stroke, systemic embolism and bleeding outcomes with warfarin anticoagulation in non-valvular atrial fibrillation (s(4)-bow-af)
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10153743/
https://www.ncbi.nlm.nih.gov/pubmed/37143610
http://dx.doi.org/10.1093/ehjopen/oead037
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