Dataset Information

In atrial fibrillation epilepsy risk differs between oral anticoagulants: active comparator, nested case-control study.

ABSTRACT:

Aims

Atrial fibrillation (AF) is a risk factor for brain infarction, which can lead to epilepsy. We aimed to investigate whether treatment of AF with direct oral anticoagulants (DOACs) affects the risk of epilepsy in comparison to treatment with the vitamin K antagonist phenprocoumon (PPC).

Methods and results

We performed an active comparator, nested case-control study based on the German Pharmacoepidemiological Research Database that includes claims data from statutory health insurance providers of about 25 million persons since 2004. In 2011-17, 227 707 AF patients initiated treatment with a DOAC or PPC, of which 1828 cases developed epilepsy on current treatment with an oral anticoagulant. They were matched to 19 084 controls without epilepsy. Patients with DOAC treatment for AF had an overall higher risk of epilepsy with an odds ratio of 1.39, 95% CI (1.24; 1.55) compared to current PPC treatment. Cases had higher baseline CHA2DS2-VASc scores and more frequently a history of stroke than controls. After excluding patients with ischaemic stroke prior to the diagnosis of epilepsy, the risk of epilepsy was still higher on DOACs than on PPC. In contrast, within a cohort of patients with venous thromboembolism, the risk of epilepsy on treatment with DOACs was less elevated [adjusted odds ratio 1.15, 95% CI (0.98; 1.34)].

Conclusion

In patients with AF initiating oral anticoagulation, treatment with a DOAC was associated with an increased risk of epilepsy compared to the vitamin K antagonist PPC. Covert brain infarction may explain the observed elevated risk of epilepsy.

SUBMITTER: Platzbecker K

PROVIDER: S-EPMC10228540 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature

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Publications

In atrial fibrillation epilepsy risk differs between oral anticoagulants: active comparator, nested case-control study.

Platzbecker Katharina K Müller-Fielitz Helge H Foraita Ronja R Koepp Matthias J MJ Voss Annemarie A Pflock René R Linder Roland R Pigeot Iris I Schink Tania T Schwaninger Markus M

Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology 20230501 5

<h4>Aims</h4>Atrial fibrillation (AF) is a risk factor for brain infarction, which can lead to epilepsy. We aimed to investigate whether treatment of AF with direct oral anticoagulants (DOACs) affects the risk of epilepsy in comparison to treatment with the vitamin K antagonist phenprocoumon (PPC).<h4>Methods and results</h4>We performed an active comparator, nested case-control study based on the German Pharmacoepidemiological Research Database that includes claims data from statutory health in ...[more]

PMID: 37013704

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Project description:OBJECTIVES:Older adult patients are underrepresented in clinical trials comparing non-vitamin K antagonist oral anticoagulants (NOACs) and warfarin. This subgroup analysis of the ARISTOPHANES study used multiple data sources to compare the risk of stroke/systemic embolism (SE) and major bleeding (MB) among very old patients with nonvalvular atrial fibrillation (NVAF) prescribed NOACs or warfarin. DESIGN:Retrospective observational study. SETTING:The Centers for Medicare & Medicaid Services and three US commercial claims databases. PARTICIPANTS:A total of 88 582 very old (aged ≥80 y) NVAF patients newly initiating apixaban, dabigatran, rivaroxaban, or warfarin from January 1, 2013, to September 30, 2015. MEASUREMENTS:In each database, six 1:1 propensity score matched (PSM) cohorts were created for each drug comparison. Patient cohorts were pooled from all four databases after PSM. Cox proportional hazards models were used to estimate hazard ratios (HRs) of stroke/SE and MB. RESULTS:The patients in the six matched cohorts had a mean follow-up time of 7 to 9 months. Compared with warfarin, apixaban (HR = .58; 95% confidence interval [CI] = .49-.69), dabigatran (HR = .77; 95% CI = .60-.99), and rivaroxaban (HR = .74; 95% CI = .65-.85) were associated with lower risks of stroke/SE. For MB, apixaban (HR = .60; 95% CI = .54-.67) was associated with a lower risk; dabigatran (HR = .92; 95% CI = .78-1.07) was associated with a similar risk, and rivaroxaban (HR = 1.16; 95% CI = 1.07-1.24) was associated with a higher risk compared with warfarin. Apixaban was associated with a lower risk of stroke/SE and MB compared with dabigatran (stroke/SE: HR = .65; 95% CI = .47-.89; MB: HR = .60; 95% CI = .49-.73) and rivaroxaban (stroke/SE: HR = .72; 95% CI = .59-.86; MB: HR = .50; 95% CI = .45-.55). Dabigatran was associated with a lower risk of MB (HR = .77; 95% CI = .67-.90) compared with rivaroxaban. CONCLUSION:Among very old NVAF patients, NOACs were associated with lower rates of stroke/SE and varying rates of MB compared with warfarin. J Am Geriatr Soc 67:1662-1671, 2019.

Project description:INTRODUCTION: Oral anticoagulants (OAs) are significantly more effective than Aspirin in the prevention of cerebrovascular accidents among patients with atrial fibrillation (AF). Several studies, however, showed OAs to be widely underused in these patients. OBJECTIVE: To assess the appropriateness of antithrombotic therapy in an Italian population of AF patients. METHODS: Two hundred and fifty-five consecutive patients affected by nonvalvular AF participated in the study. Data were collected on demographic characteristics, risk factors for stroke, current prophylactic therapy, and perceived or actual risk factors for bleeding. INR levels were measured. Patients were stratified by their risk for stroke (214 at high risk, 21 moderate, 20 low), and their prophylactic therapy was analysed in light of international antithrombotic therapy recommendations. After therapy adjustment, 203 of our patients were followed-up for the occurrence of cerebrovascular events for an average of 27 months. RESULTS: Upon admission, 35% (n=75) of patients in the high-risk category were either taking no antithrombotic prophylaxis or were being treated with Aspirin. In addition, 38 of 139 patients receiving OAs had an INR<2. Thus, a total of 113 (52.8%) high-risk subjects were not receiving adequate antithrombotic therapy. Of high-risk patients not treated with OAs, 46.7% reported no perceived or actual risk factors for bleeding. The annual incidence of cerebrovascular accidents was 3.8% among 163 high-risk patients assigned to OA treatment, and 4.5% among 39 patients given Aspirin treatment. Relative to expected annual incidence rates, cerebrovascular risk in anticoagulated patients was reduced by about 70%. CONCLUSIONS: Underuse of OAs is still common in Italy, and much of it cannot be explained by the concern for haemorrhage. Support and training in the complex task of anticoagulation management may help to extend this efficacious prophylactic therapy to all patients who may benefit from it.

Project description:Background and Purpose- This ARISTOPHANES study (Anticoagulants for Reduction in Stroke: Observational Pooled Analysis on Health Outcomes and Experience of Patients) used multiple data sources to compare stroke/systemic embolism (SE) and major bleeding (MB) among a large number of nonvalvular atrial fibrillation patients on non-vitamin K antagonist oral anticoagulants (NOACs) or warfarin. Methods- A retrospective observational study of nonvalvular atrial fibrillation patients initiating apixaban, dabigatran, rivaroxaban, or warfarin from January 1, 2013, to September 30, 2015, was conducted pooling Centers for Medicare and Medicaid Services Medicare data and 4 US commercial claims databases. After 1:1 NOAC-warfarin and NOAC-NOAC propensity score matching in each database, the resulting patient records were pooled. Cox models were used to evaluate the risk of stroke/SE and MB across matched cohorts. Results- A total of 285 292 patients were included in the 6 matched cohorts: 57 929 apixaban-warfarin, 26 838 dabigatran-warfarin, 83 007 rivaroxaban-warfarin, 27 096 apixaban-dabigatran, 62 619 apixaban-rivaroxaban, and 27 538 dabigatran-rivaroxaban patient pairs. Apixaban (hazard ratio [HR], 0.61; 95% CI, 0.54-0.69), dabigatran (HR, 0.80; 95% CI, 0.68-0.94), and rivaroxaban (HR, 0.75; 95% CI, 0.69-0.82) were associated with lower rates of stroke/SE compared with warfarin. Apixaban (HR, 0.58; 95% CI, 0.54-0.62) and dabigatran (HR, 0.73; 95% CI, 0.66-0.81) had lower rates of MB, and rivaroxaban (HR, 1.07; 95% CI, 1.02-1.13) had a higher rate of MB compared with warfarin. Differences exist in rates of stroke/SE and MB across NOACs. Conclusions- In this largest observational study to date on NOACs and warfarin, the NOACs had lower rates of stroke/SE and variable comparative rates of MB versus warfarin. The findings from this study may help inform the discussion on benefit and risk in the shared decision-making process for stroke prevention between healthcare providers and nonvalvular atrial fibrillation patients. Clinical Trial Registration- URL: https://www.clinicaltrials.gov/ . Unique identifier: NCT03087487.

Dataset Information

In atrial fibrillation epilepsy risk differs between oral anticoagulants: active comparator, nested case-control study.

Aims

Methods and results

Conclusion

Publications

In atrial fibrillation epilepsy risk differs between oral anticoagulants: active comparator, nested case-control study.

Similar Datasets

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