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Association of stroke and bleed events in non-valvular atrial fibrillation patients with direct oral anticoagulant prescriptions in NHS England between 2013 and 2016.

ABSTRACT: Prescription of direct oral anticoagulants (DOAC) compared to warfarin for treating atrial fibrillation patients have increased substantially since their introduction in the England's National Health Service. Assessment of the risk of strokes and bleeds in relation to the large-scale uptake in DOACs compared to warfarin at the clinical commissioning group (CCG) level needs to be carried out. Publicly available- aggregated, CCG level, multi-source health and prescription records data were interrogated to investigate the association between prescription rate of DOACs and stroke/ bleed events during the period of 2013 to 2016. Variability of prescription rates and patient numbers across 208 CCGs were used to infer the effect of DOACs on stroke and bleed risk. Relative risk (RR) and 95% credible intervals (CI) were estimated using Markov chain Monte Carlo approach in JAGS. During the study period, the proportion of DOAC prescriptions increased at an average rate of 122% per annum. DOAC prescription was association with a 50% reduction in ischaemic (RR = 0.48, 95% CI = 0.39, 0.57) and haemorrhagic stroke (RR = 0.50, 95% CI = 0.26-0.77). In contrast, DOAC prescription reached significant association with reduction in gastrointestinal bleeds (RR = 0.86, 95% CI = 0.73-0.98) but not clinically relevant bleeds (RR = 0.95, 95% CI = 0.85-1.05). Sex stratified data showed significant association between DOAC prescription and reduction in haemorrhagic stroke risk (RR = 0.40, 95% CI = 0.28-0.52) and gastrointestinal bleeds (RR = 0.76, 95% CI = 0.63-0.93) in males only. Age stratified data suggested significant association with reduction in risk of both ischaemic and haemorrhagic strokes in patients aged 70 years and above, and reduction in risk of clinically relevant and gastrointestinal bleeds in patients aged 70-79 years only. Publicly available health and prescription data for the English population indicates reduction in stroke and bleed risk in specific age and sex sub-groups with the uptake of DOACs compared to warfarin between 2013 and 2016.

SUBMITTER: Sheth H

PROVIDER: S-EPMC6590892 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:This study examined characteristics and treatment persistence among patients prescribed oral anticoagulants (OACs) for stroke prevention in non-valvular atrial fibrillation (NVAF). We identified 15,244 patients (51.8% male, 72.7% aged ?70) with NVAF and no prior OAC therapy who were prescribed apixaban (n = 1,303), rivaroxaban (n = 5,742), dabigatran (n = 1,622) or vitamin-K antagonists (VKAs, n = 6,577) between 1-Dec-2012 and 31-Oct-2014 in German primary care (IMS® Disease Analyzer). We compared OAC persistence using Cox regression over patients' entire follow-up and using a data-driven time-partitioned approach (before/after 100 days) to handle non-proportional hazards. History of stroke risk factors (stroke/transient ischaemic attack [TIA] 15.2%; thromboembolism 14.1%; hypertension 84.3%) and high bleeding risk (HAS-BLED score?3 68.4%) was common. Apixaban-prescribed patients had more frequent history of stroke/TIA (19.7%) and high bleeding risk (72.6%) than other OACs. 12-month persistence rates were: VKA 57.5% (95% confidence interval (CI) 56.0-59.0%), rivaroxaban 56.6% (54.9-58.2%), dabigatran 50.1% (47.2-53.1%), apixaban 62.9% (58.8-67.0%). Over entire follow-up, compared to VKA, non-persistence was similar with apixaban (adjusted hazard ratio 1.08, 95% CI 0.95-1.24) but higher with rivaroxaban (1.21, 1.14-1.29) and dabigatran (1.53, 1.40-1.68). Using post-hoc time-partitioned approach: in first 100 days, non-persistence was higher with apixaban (1.37, 1.17-1.59), rivaroxaban (1.41, 1.30-1.53) and dabigatran (1.91, 1.70-2.14) compared to VKA. Compared to apixaban, rivaroxaban non-persistence was similar (1.03, 0.89-1.20), dabigatran was higher (1.39, 1.17-1.66). After 100 days, apixaban non-persistence was lower than VKA (0.66, 0.52-0.85); rivaroxaban (0.97, 0.87-1.07) and dabigatran (1.10, 0.95-1.28) were similar to VKA. Furthermore, rivaroxaban (1.46, 1.13-1.88) and dabigatran (1.67, 1.26-2.19) non-persistence was higher than apixaban. This study describes real-world observations on OAC use, particularly early apixaban use following approval for NVAF, in Germany. We identified potential differential OAC prescribing and higher persistence with apixaban than other OACs after 100 days' treatment. Larger studies are needed with longer follow-up to establish long-term patterns.

Project description:ObjectiveOur objective was to compare all-cause and stroke- and bleed-specific healthcare costs among patients with non-valvular atrial fibrillation (NVAF) treated with dabigatran or warfarin.MethodsAdministrative claims data from the MarketScan® Databases for 2009-2014 were used. Patients with NVAF newly treated with dabigatran were matched 1:1 to those treated with warfarin. All-cause and stroke- and bleed-specific costs per patient per month (PPPM) ($US, year 2015 values) up to a 12-month follow-up period were analyzed. Stroke- or bleed-specific costs were defined as hospitalizations with stroke or bleed as the primary discharge diagnosis and outpatient claims with stroke or bleed diagnosis in any position. Differences in costs between dabigatran and warfarin users were assessed using descriptive and multivariate analyses.ResultsA total of 18,980 dabigatran-treated patients were matched to corresponding warfarin-treated patients. Adjusted all-cause total healthcare, inpatient, and outpatient costs were significantly lower for the dabigatran cohort ($US3053 vs. 3433; $US904 vs. 1194; $US1594 vs. 1894, respectively; all p < 0.001), but mean pharmacy costs were significantly higher ($US556 vs. 345, p < 0.001). Stroke-specific total healthcare and outpatient costs were significantly lower for the dabigatran than for the warfarin cohort ($US30.37 vs. 40.99 and $US7.36 vs. 12.20, respectively; p < 0.05 for both values). Similarly, bleed-specific total healthcare and inpatient costs were significantly lower for the dabigatran than for the warfarin cohort ($US50.00 vs. 73.49 and $US27.75 vs. 48.66, respectively; p < 0.01 for both values).ConclusionPatients receiving dabigatran had significantly lower total all-cause, inpatient, and outpatient costs but higher pharmacy costs than those receiving warfarin. In addition, stroke-specific total and outpatient costs and bleed-specific total and inpatient costs were significantly lower in dabigatran users compared with warfarin users.

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Association of stroke and bleed events in non-valvular atrial fibrillation patients with direct oral anticoagulant prescriptions in NHS England between 2013 and 2016.

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