TY - JOUR
T1 - Risk of Stroke Outcomes in Atrial Fibrillation Patients Treated with Rivaroxaban and Warfarin
AU - Milentijevic, Dejan
AU - Lin, Jennifer H.
AU - Connolly, Nancy
AU - Chen, Yen Wen
AU - Kogan, Emily
AU - Shrivastava, Shubham
AU - Sjoeland, Erik
AU - Alberts, Mark J.
N1 - Funding Information:
Medical writing support was provided by Michelle McDermott, PharmD, of MedErgy (Yardley, PA), which was funded by Janssen Scientific Affairs, LLC (Titusville, NJ).
Funding Information:
This work was supported by Janssen Scientific Affairs, LLC. The sponsor was involved in study design; in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the article for publication.
Publisher Copyright:
© 2021 The Authors
PY - 2021/5
Y1 - 2021/5
N2 - Objectives: In a previous real-world study, rivaroxaban reduced the risk of stroke overall and severe stroke compared with warfarin in patients with nonvalvular atrial fibrillation (NVAF). The aim of this study was to assess the reproducibility in a different database of our previously observed results (Alberts M, et al. Stroke. 2020;51:549-555) on the risk of severe stroke among NVAF patients in a different population treated with rivaroxaban or warfarin. Material and Methods: This retrospective cohort study included patients from the IBM® MarketScan® Commercial and Medicare databases (2011-2019) who initiated rivaroxaban or warfarin after a diagnosis of NVAF, had ≥6 months of continuous health plan enrollment, had a CHA2DS2-VASc score ≥2, and had no history of stroke or anticoagulant use. Patient data were assessed until the earliest occurrence of a primary inpatient diagnosis of stroke, death, end of health plan enrollment, or end of study. Stroke severity was defined by National Institutes of Health Stroke Scale (NIHSS) score, imputed by random forest model. Cox proportional hazard regression was used to compare risk of stroke between cohorts, balanced by inverse probability of treatment weighting. Results: The mean observation period from index date to either stroke, or end of eligibility or end of data was 28 months. Data from 13,599 rivaroxaban and 39,861 warfarin patients were included. Stroke occurred in 272 rivaroxaban-treated patients (0.97/100 person-years [PY]) and 1,303 warfarin-treated patients (1.32/100 PY). Rivaroxaban patients had lower risk for stroke overall (hazard ratio [HR], 0.82; 95% confidence interval [CI], 0.76–0.88) and for minor (NIHSS 1 to <5; HR, 0.83; 95% CI, 0.74–0.93), moderate (NIHSS 5 to <16; HR, 0.88; 95% CI, 0.78–0.99), and severe stroke (NIHSS 16 to 42; HR, 0.44; 95% CI, 0.22–0.91). Conclusions: The results of this study in a larger population of NVAF patients align with previous real-world findings and the ROCKET-AF trial by showing improved stroke prevention with rivaroxaban versus warfarin across all stroke severities.
AB - Objectives: In a previous real-world study, rivaroxaban reduced the risk of stroke overall and severe stroke compared with warfarin in patients with nonvalvular atrial fibrillation (NVAF). The aim of this study was to assess the reproducibility in a different database of our previously observed results (Alberts M, et al. Stroke. 2020;51:549-555) on the risk of severe stroke among NVAF patients in a different population treated with rivaroxaban or warfarin. Material and Methods: This retrospective cohort study included patients from the IBM® MarketScan® Commercial and Medicare databases (2011-2019) who initiated rivaroxaban or warfarin after a diagnosis of NVAF, had ≥6 months of continuous health plan enrollment, had a CHA2DS2-VASc score ≥2, and had no history of stroke or anticoagulant use. Patient data were assessed until the earliest occurrence of a primary inpatient diagnosis of stroke, death, end of health plan enrollment, or end of study. Stroke severity was defined by National Institutes of Health Stroke Scale (NIHSS) score, imputed by random forest model. Cox proportional hazard regression was used to compare risk of stroke between cohorts, balanced by inverse probability of treatment weighting. Results: The mean observation period from index date to either stroke, or end of eligibility or end of data was 28 months. Data from 13,599 rivaroxaban and 39,861 warfarin patients were included. Stroke occurred in 272 rivaroxaban-treated patients (0.97/100 person-years [PY]) and 1,303 warfarin-treated patients (1.32/100 PY). Rivaroxaban patients had lower risk for stroke overall (hazard ratio [HR], 0.82; 95% confidence interval [CI], 0.76–0.88) and for minor (NIHSS 1 to <5; HR, 0.83; 95% CI, 0.74–0.93), moderate (NIHSS 5 to <16; HR, 0.88; 95% CI, 0.78–0.99), and severe stroke (NIHSS 16 to 42; HR, 0.44; 95% CI, 0.22–0.91). Conclusions: The results of this study in a larger population of NVAF patients align with previous real-world findings and the ROCKET-AF trial by showing improved stroke prevention with rivaroxaban versus warfarin across all stroke severities.
KW - Atrial fibrillation
KW - Direct-acting oral anticoagulants
KW - mortality
KW - Rivaroxaban
KW - Stroke
KW - Warfarin
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U2 - 10.1016/j.jstrokecerebrovasdis.2021.105715
DO - 10.1016/j.jstrokecerebrovasdis.2021.105715
M3 - Article
C2 - 33743312
AN - SCOPUS:85102634926
SN - 1052-3057
VL - 30
JO - Journal of Stroke and Cerebrovascular Diseases
JF - Journal of Stroke and Cerebrovascular Diseases
IS - 5
M1 - 105715
ER -