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SAIL Study of Stroke, Systemic Embolism and Bleeding, Outcomes with Warfarin Anticoagulation in Non Valvular Atrial Fibrillation (S4-BOW-AF)

Daniel Harris, Fatemeh Torabi Orcid Logo, Daniel Mallory, Ashley Akbari Orcid Logo, Daniel Thayer Orcid Logo, Ting Wang, Sarah Grundy, Michael Gravenor Orcid Logo, Raza Alikhan, Steven Lister, Julian Halcox Orcid Logo

European Heart Journal Open

Swansea University Authors: Daniel Harris, Fatemeh Torabi Orcid Logo, Ashley Akbari Orcid Logo, Daniel Thayer Orcid Logo, Ting Wang, Michael Gravenor Orcid Logo, Julian Halcox Orcid Logo

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DOI (Published version): 10.1093/ehjopen/oead037

Abstract

AbstractAimsIn 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 p...

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Published in: European Heart Journal Open
ISSN: 2752-4191
Published: Oxford University Press (OUP) 2023
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URI: https://cronfa.swan.ac.uk/Record/cronfa63179
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fullrecord <?xml version="1.0" encoding="utf-8"?><rfc1807 xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns:xsd="http://www.w3.org/2001/XMLSchema"><bib-version>v2</bib-version><id>63179</id><entry>2023-04-17</entry><title>SAIL Study of Stroke, Systemic Embolism and Bleeding, Outcomes with Warfarin Anticoagulation in Non Valvular Atrial Fibrillation (S4-BOW-AF)</title><swanseaauthors><author><sid>e60c9c73b645f0e8033ae26fa8e634b8</sid><firstname>Daniel</firstname><surname>Harris</surname><name>Daniel Harris</name><active>true</active><ethesisStudent>false</ethesisStudent></author><author><sid>f569591e1bfb0e405b8091f99fec45d3</sid><ORCID>0000-0002-5853-4625</ORCID><firstname>Fatemeh</firstname><surname>Torabi</surname><name>Fatemeh Torabi</name><active>true</active><ethesisStudent>false</ethesisStudent></author><author><sid>aa1b025ec0243f708bb5eb0a93d6fb52</sid><ORCID>0000-0003-0814-0801</ORCID><firstname>Ashley</firstname><surname>Akbari</surname><name>Ashley Akbari</name><active>true</active><ethesisStudent>false</ethesisStudent></author><author><sid>e1a6d9b30965cc61a76371fc8a1bf232</sid><ORCID>0000-0003-1847-4362</ORCID><firstname>Daniel</firstname><surname>Thayer</surname><name>Daniel Thayer</name><active>true</active><ethesisStudent>false</ethesisStudent></author><author><sid>07cadc7e2e640735ae1f5bd948b74f6c</sid><ORCID></ORCID><firstname>Ting</firstname><surname>Wang</surname><name>Ting Wang</name><active>true</active><ethesisStudent>false</ethesisStudent></author><author><sid>70a544476ce62ba78502ce463c2500d6</sid><ORCID>0000-0003-0710-0947</ORCID><firstname>Michael</firstname><surname>Gravenor</surname><name>Michael Gravenor</name><active>true</active><ethesisStudent>false</ethesisStudent></author><author><sid>3676f695eeda169d0f8c618adf27c04b</sid><ORCID>0000-0001-6926-2947</ORCID><firstname>Julian</firstname><surname>Halcox</surname><name>Julian Halcox</name><active>true</active><ethesisStudent>false</ethesisStudent></author></swanseaauthors><date>2023-04-17</date><deptcode>MEDS</deptcode><abstract>AbstractAimsIn 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 resultsIndividual-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) &lt;65%, two INRs &lt;1.5 or two INRs &gt;5 in a 6-month period or any INR &gt;8]. A total of 35 891 patients were included for SSE and 35 035 for bleeding outcome analyses. Mean CHA2DS2-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 &lt; 0.001] and bleeding [HR = 1.40 (95%CI 1.33–1.48), P &lt; 0.001] in Cox-multivariable models.ConclusionGuideline-defined poor INR control is associated with significantly higher SSE and bleeding event rates, independent of recognised risk factors for stroke or bleeding.</abstract><type>Journal Article</type><journal>European Heart Journal Open</journal><volume>0</volume><journalNumber/><paginationStart/><paginationEnd/><publisher>Oxford University Press (OUP)</publisher><placeOfPublication/><isbnPrint/><isbnElectronic/><issnPrint/><issnElectronic>2752-4191</issnElectronic><keywords>Atrial fibrillation, Warfarin, INR control, Stroke, Bleeding, Pharmacotherapy</keywords><publishedDay>13</publishedDay><publishedMonth>4</publishedMonth><publishedYear>2023</publishedYear><publishedDate>2023-04-13</publishedDate><doi>10.1093/ehjopen/oead037</doi><url>http://dx.doi.org/10.1093/ehjopen/oead037</url><notes/><college>COLLEGE NANME</college><department>Medical School</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>MEDS</DepartmentCode><institution>Swansea University</institution><apcterm>SU Library paid the OA fee (TA Institutional Deal)</apcterm><funders>This study makes use of anonymised data held in the Secure Anonymised Information Linkage (SAIL) Databank. We would like to acknowledge all the data providers who make anonymised data available for research. This work uses data provided by patients and collected by the NHS as part of their care and support. This work was supported by Health Data Research UK, which receives its funding from HDR UK Ltd (HDR-9006) funded by the UK Medical Research Council, Engineering and Physical Sciences Research Council, Economic and Social Research Council, Department of Health and Social Care (England), Chief Scientist Office of the Scottish Government Health and Social Care Directorates, Health and Social Care Research and Development Division (Welsh Government), Public Health Agency (Northern Ireland), British Heart Foundation (BHF) and the Wellcome Trust. This study was supported by an unrestricted research grant from Pfizer and Bristol Myers Squibb.</funders><projectreference/><lastEdited>2024-07-15T12:17:11.9192781</lastEdited><Created>2023-04-17T19:27:18.8345624</Created><path><level id="1">Faculty of Medicine, Health and Life Sciences</level><level id="2">Swansea University Medical School - Health Data Science</level></path><authors><author><firstname>Daniel</firstname><surname>Harris</surname><order>1</order></author><author><firstname>Fatemeh</firstname><surname>Torabi</surname><orcid>0000-0002-5853-4625</orcid><order>2</order></author><author><firstname>Daniel</firstname><surname>Mallory</surname><order>3</order></author><author><firstname>Ashley</firstname><surname>Akbari</surname><orcid>0000-0003-0814-0801</orcid><order>4</order></author><author><firstname>Daniel</firstname><surname>Thayer</surname><orcid>0000-0003-1847-4362</orcid><order>5</order></author><author><firstname>Ting</firstname><surname>Wang</surname><orcid></orcid><order>6</order></author><author><firstname>Sarah</firstname><surname>Grundy</surname><order>7</order></author><author><firstname>Michael</firstname><surname>Gravenor</surname><orcid>0000-0003-0710-0947</orcid><order>8</order></author><author><firstname>Raza</firstname><surname>Alikhan</surname><order>9</order></author><author><firstname>Steven</firstname><surname>Lister</surname><order>10</order></author><author><firstname>Julian</firstname><surname>Halcox</surname><orcid>0000-0001-6926-2947</orcid><order>11</order></author></authors><documents><document><filename>63179__27438__aa2d79905a154bcfb753980b59e96bad.pdf</filename><originalFilename>63179.pdf</originalFilename><uploaded>2023-05-11T13:21:49.2018396</uploaded><type>Output</type><contentLength>613929</contentLength><contentType>application/pdf</contentType><version>Version of Record</version><cronfaStatus>true</cronfaStatus><documentNotes>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.</documentNotes><copyrightCorrect>true</copyrightCorrect><language>eng</language><licence>https://creativecommons.org/licenses/by/4.0/</licence></document></documents><OutputDurs/></rfc1807>
spelling v2 63179 2023-04-17 SAIL Study of Stroke, Systemic Embolism and Bleeding, Outcomes with Warfarin Anticoagulation in Non Valvular Atrial Fibrillation (S4-BOW-AF) e60c9c73b645f0e8033ae26fa8e634b8 Daniel Harris Daniel Harris true false f569591e1bfb0e405b8091f99fec45d3 0000-0002-5853-4625 Fatemeh Torabi Fatemeh Torabi true false aa1b025ec0243f708bb5eb0a93d6fb52 0000-0003-0814-0801 Ashley Akbari Ashley Akbari true false e1a6d9b30965cc61a76371fc8a1bf232 0000-0003-1847-4362 Daniel Thayer Daniel Thayer true false 07cadc7e2e640735ae1f5bd948b74f6c Ting Wang Ting Wang true false 70a544476ce62ba78502ce463c2500d6 0000-0003-0710-0947 Michael Gravenor Michael Gravenor true false 3676f695eeda169d0f8c618adf27c04b 0000-0001-6926-2947 Julian Halcox Julian Halcox true false 2023-04-17 MEDS AbstractAimsIn 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 resultsIndividual-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 CHA2DS2-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.ConclusionGuideline-defined poor INR control is associated with significantly higher SSE and bleeding event rates, independent of recognised risk factors for stroke or bleeding. Journal Article European Heart Journal Open 0 Oxford University Press (OUP) 2752-4191 Atrial fibrillation, Warfarin, INR control, Stroke, Bleeding, Pharmacotherapy 13 4 2023 2023-04-13 10.1093/ehjopen/oead037 http://dx.doi.org/10.1093/ehjopen/oead037 COLLEGE NANME Medical School COLLEGE CODE MEDS Swansea University SU Library paid the OA fee (TA Institutional Deal) This study makes use of anonymised data held in the Secure Anonymised Information Linkage (SAIL) Databank. We would like to acknowledge all the data providers who make anonymised data available for research. This work uses data provided by patients and collected by the NHS as part of their care and support. This work was supported by Health Data Research UK, which receives its funding from HDR UK Ltd (HDR-9006) funded by the UK Medical Research Council, Engineering and Physical Sciences Research Council, Economic and Social Research Council, Department of Health and Social Care (England), Chief Scientist Office of the Scottish Government Health and Social Care Directorates, Health and Social Care Research and Development Division (Welsh Government), Public Health Agency (Northern Ireland), British Heart Foundation (BHF) and the Wellcome Trust. This study was supported by an unrestricted research grant from Pfizer and Bristol Myers Squibb. 2024-07-15T12:17:11.9192781 2023-04-17T19:27:18.8345624 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Health Data Science Daniel Harris 1 Fatemeh Torabi 0000-0002-5853-4625 2 Daniel Mallory 3 Ashley Akbari 0000-0003-0814-0801 4 Daniel Thayer 0000-0003-1847-4362 5 Ting Wang 6 Sarah Grundy 7 Michael Gravenor 0000-0003-0710-0947 8 Raza Alikhan 9 Steven Lister 10 Julian Halcox 0000-0001-6926-2947 11 63179__27438__aa2d79905a154bcfb753980b59e96bad.pdf 63179.pdf 2023-05-11T13:21:49.2018396 Output 613929 application/pdf Version of Record true 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. true eng https://creativecommons.org/licenses/by/4.0/
title SAIL Study of Stroke, Systemic Embolism and Bleeding, Outcomes with Warfarin Anticoagulation in Non Valvular Atrial Fibrillation (S4-BOW-AF)
spellingShingle SAIL Study of Stroke, Systemic Embolism and Bleeding, Outcomes with Warfarin Anticoagulation in Non Valvular Atrial Fibrillation (S4-BOW-AF)
Daniel Harris
Fatemeh Torabi
Ashley Akbari
Daniel Thayer
Ting Wang
Michael Gravenor
Julian Halcox
title_short SAIL Study of Stroke, Systemic Embolism and Bleeding, Outcomes with Warfarin Anticoagulation in Non Valvular Atrial Fibrillation (S4-BOW-AF)
title_full SAIL Study of Stroke, Systemic Embolism and Bleeding, Outcomes with Warfarin Anticoagulation in Non Valvular Atrial Fibrillation (S4-BOW-AF)
title_fullStr SAIL Study of Stroke, Systemic Embolism and Bleeding, Outcomes with Warfarin Anticoagulation in Non Valvular Atrial Fibrillation (S4-BOW-AF)
title_full_unstemmed SAIL Study of Stroke, Systemic Embolism and Bleeding, Outcomes with Warfarin Anticoagulation in Non Valvular Atrial Fibrillation (S4-BOW-AF)
title_sort SAIL Study of Stroke, Systemic Embolism and Bleeding, Outcomes with Warfarin Anticoagulation in Non Valvular Atrial Fibrillation (S4-BOW-AF)
author_id_str_mv e60c9c73b645f0e8033ae26fa8e634b8
f569591e1bfb0e405b8091f99fec45d3
aa1b025ec0243f708bb5eb0a93d6fb52
e1a6d9b30965cc61a76371fc8a1bf232
07cadc7e2e640735ae1f5bd948b74f6c
70a544476ce62ba78502ce463c2500d6
3676f695eeda169d0f8c618adf27c04b
author_id_fullname_str_mv e60c9c73b645f0e8033ae26fa8e634b8_***_Daniel Harris
f569591e1bfb0e405b8091f99fec45d3_***_Fatemeh Torabi
aa1b025ec0243f708bb5eb0a93d6fb52_***_Ashley Akbari
e1a6d9b30965cc61a76371fc8a1bf232_***_Daniel Thayer
07cadc7e2e640735ae1f5bd948b74f6c_***_Ting Wang
70a544476ce62ba78502ce463c2500d6_***_Michael Gravenor
3676f695eeda169d0f8c618adf27c04b_***_Julian Halcox
author Daniel Harris
Fatemeh Torabi
Ashley Akbari
Daniel Thayer
Ting Wang
Michael Gravenor
Julian Halcox
author2 Daniel Harris
Fatemeh Torabi
Daniel Mallory
Ashley Akbari
Daniel Thayer
Ting Wang
Sarah Grundy
Michael Gravenor
Raza Alikhan
Steven Lister
Julian Halcox
format Journal article
container_title European Heart Journal Open
container_volume 0
publishDate 2023
institution Swansea University
issn 2752-4191
doi_str_mv 10.1093/ehjopen/oead037
publisher Oxford University Press (OUP)
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Health Data Science{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Health Data Science
url http://dx.doi.org/10.1093/ehjopen/oead037
document_store_str 1
active_str 0
description AbstractAimsIn 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 resultsIndividual-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 CHA2DS2-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.ConclusionGuideline-defined poor INR control is associated with significantly higher SSE and bleeding event rates, independent of recognised risk factors for stroke or bleeding.
published_date 2023-04-13T12:17:10Z
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score 11.016235

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