Shun Kohsaka1, Jun Katada2, Kumiko Saito3, Yasuo Terayama4. 1. a Department of Cardiology , Keio University School of Medicine , Tokyo , Japan. 2. b Pfizer Japan Inc. , Tokyo , Japan. 3. c Bristol-Myers Squibb K.K. , Tokyo , Japan. 4. d Department of Gerontology , School of Medicine, Iwate Medical University , Iwate , Japan.
Abstract
OBJECTIVE: To investigate the risk of bleeding events and stroke/systemic embolism (SE) among Japanese patients with nonvalvular atrial fibrillation (NVAF), focusing on the initial dosage of apixaban and patient age. METHODS: This retrospective cohort study used de-identified electronic health records based claims data from 314 acute-care hospitals in Japan. NVAF patients newly initiated on warfarin or apixaban, with no prescription during the 180-day blanking period, were eligible. Patients were allocated to receive warfarin or 5 or 2.5 mg twice daily (BID) apixaban. One-to-one propensity-score matching was used to balance patient characteristics between apixaban and warfarin. RESULTS: Among 31,006 eligible patients, 11,972 matched pairs were identified for apixaban versus warfarin. Mean age ± standard deviation was 77.7 ± 10.0 and 77.6 ± 10.0 years and CHADS2 score was 2.2 ± 1.4 and 2.2 ± 1.4 for warfarin and apixaban, respectively. In the apixaban cohort, 39.4% of patients received the standard dose (5 mg BID) and 60.6% received the reduced dose (2.5 mg BID). Incidence rates (events per 100 person-years) of major bleeding, any bleeding and stroke/SE were 3.7, 23.1 and 3.1, and 2.5, 18.6 and 2.0 for warfarin and apixaban cohorts, respectively. Apixaban was associated with a significantly lower risk of any bleeding (hazard ratio [HR] 0.809, 95% confidence interval [CI] 0.731-0.895; p < .001), major bleeding (HR 0.655, 95% CI 0.505-0.849; p = .001) and stroke/SE (HR 0.637, 95% CI 0.478-0.850; p = .002). CONCLUSIONS: Our observational data from clinical practice broadly confirms the safety and efficacy results of pivotal randomized controlled trials of apixaban for stroke prevention among NVAF patients.
OBJECTIVE: To investigate the risk of bleeding events and stroke/systemic embolism (SE) among Japanese patients with nonvalvular atrial fibrillation (NVAF), focusing on the initial dosage of apixaban and patient age. METHODS: This retrospective cohort study used de-identified electronic health records based claims data from 314 acute-care hospitals in Japan. NVAFpatients newly initiated on warfarin or apixaban, with no prescription during the 180-day blanking period, were eligible. Patients were allocated to receive warfarin or 5 or 2.5 mg twice daily (BID) apixaban. One-to-one propensity-score matching was used to balance patient characteristics between apixaban and warfarin. RESULTS: Among 31,006 eligible patients, 11,972 matched pairs were identified for apixaban versus warfarin. Mean age ± standard deviation was 77.7 ± 10.0 and 77.6 ± 10.0 years and CHADS2 score was 2.2 ± 1.4 and 2.2 ± 1.4 for warfarin and apixaban, respectively. In the apixaban cohort, 39.4% of patients received the standard dose (5 mg BID) and 60.6% received the reduced dose (2.5 mg BID). Incidence rates (events per 100 person-years) of major bleeding, any bleeding and stroke/SE were 3.7, 23.1 and 3.1, and 2.5, 18.6 and 2.0 for warfarin and apixaban cohorts, respectively. Apixaban was associated with a significantly lower risk of any bleeding (hazard ratio [HR] 0.809, 95% confidence interval [CI] 0.731-0.895; p < .001), major bleeding (HR 0.655, 95% CI 0.505-0.849; p = .001) and stroke/SE (HR 0.637, 95% CI 0.478-0.850; p = .002). CONCLUSIONS: Our observational data from clinical practice broadly confirms the safety and efficacy results of pivotal randomized controlled trials of apixaban for stroke prevention among NVAFpatients.
Authors: Benjamin J R Buckley; Deirdre A Lane; Peter Calvert; Juqian Zhang; David Gent; C Daniel Mullins; Paul Dorian; Shun Kohsaka; Stefan H Hohnloser; Gregory Y H Lip Journal: J Clin Med Date: 2022-06-30 Impact factor: 4.964
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