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SAIL Study of Stroke, Systemic Embolism and Bleeding, Outcomes with Warfarin Anticoagulation in Non Valvular Atrial Fibrillation (S4-BOW-AF)
European Heart Journal Open
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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...
|Published in:||European Heart Journal Open|
Oxford University Press (OUP)
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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.
Atrial fibrillation, Warfarin, INR control, Stroke, Bleeding, Pharmacotherapy
Faculty of Medicine, Health and Life Sciences
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.