Kazuo Minematsu1,2, Takanori Ikeda3, Satoshi Ogawa4, Takanari Kitazono5, Jyoji Nakagawara6,7, Susumu Miyamoto8, Yuji Murakawa9, Makiko Takeichi10, Yoko Kidani10, Yutaka Okayama11, Toshiyuki Sunaya12, Shoichiro Sato11, Satoshi Yamanaka10. 1. Iseikai Medical Corporation, Osaka, Japan, kminemat@ncvc.go.jp. 2. National Cerebral and Cardiovascular Center, Suita, Osaka, Japan, kminemat@ncvc.go.jp. 3. Department of Cardiovascular Medicine, Toho University Graduate School of Medicine, Tokyo, Japan. 4. International University of Health & Welfare Mita Hospital, Tokyo, Japan. 5. Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. 6. National Cerebral and Cardiovascular Center, Suita, Osaka, Japan. 7. Osaka Namba Clinic, Osaka, Japan. 8. Department of Neurosurgery, Kyoto University Graduate School of Medicine, Kyoto, Japan. 9. The 4th Department of Internal Medicine, Teikyo University School of Medicine, Mizonokuchi Hospital, Kawasaki, Japan. 10. Medical Affairs Thrombosis, Medical Affairs, Bayer Yakuhin, Ltd., Osaka, Japan. 11. Pharmacovigilance & Medical Governance, Medical Affairs, Bayer Yakuhin, Ltd., Osaka, Japan. 12. Statistics & Data Insights, Data Sciences & Analytics, Research & Development Japan, Bayer Yakuhin, Ltd., Osaka, Japan.
Abstract
INTRODUCTION: Prior stroke is a risk factor for stroke and bleeding during anticoagulation in patients with atrial fibrillation (AF). Although rivaroxaban is widely prescribed to reduce their risk of stroke in patients with nonvalvular AF (NVAF), the real-world evidence on rivaroxaban treatment is limited. We aimed to examine the outcomes of rivaroxaban treatment in NVAF patients with prior ischemic stroke/transient ischemic attack (TIA) by using the data of the Xarelto Post-Authorization Safety and Effectiveness Study in Japanese -Patients with AF, a prospective, single-arm, observational study. METHODS: The clinical outcomes of 9,578 patients who completed the 1-year follow-up were evaluated. Safety and effectiveness outcomes were compared between patients with and without prior ischemic stroke/TIA. RESULTS: Among the patients, 2,153 (22.5%) had prior ischemic stroke/TIA. They were significantly older and had lower body weight, lower creatinine clearance, higher CHADS2, CHA2DS2-VASc, and modified HAS-BLED scores as compared to those without prior ischemic stroke/TIA. Any bleeding (9.1 vs. 7.2 events per 100 patient-years), major bleeding (2.3 vs. 1.6 events per 100 patient-years), and stroke/non-central nervous system systemic embolism/myocardial infarction (3.4 vs. 1.3 events per 100 patient-years) were more frequent in patients with prior ischemic stroke/TIA. Stepwise regression analysis suggested that body weight of ≤50 kg and diabetes mellitus were predictive of major bleeding in patients with prior ischemic stroke/TIA. CONCLUSIONS: Safety and effectiveness event rates were higher in patients with prior ischemic stroke/TIA than those without. This might be explained by differences in several risk profiles including age, body weight, renal function, and risk scores such as CHADS2 between the groups. Clinicaltrials.gov: NCT01582737.
INTRODUCTION: Prior stroke is a risk factor for stroke and bleeding during anticoagulation in patients with atrial fibrillation (AF). Although rivaroxaban is widely prescribed to reduce their risk of stroke in patients with nonvalvular AF (NVAF), the real-world evidence on rivaroxaban treatment is limited. We aimed to examine the outcomes of rivaroxaban treatment in NVAF patients with prior ischemic stroke/transient ischemic attack (TIA) by using the data of the Xarelto Post-Authorization Safety and Effectiveness Study in Japanese -Patients with AF, a prospective, single-arm, observational study. METHODS: The clinical outcomes of 9,578 patients who completed the 1-year follow-up were evaluated. Safety and effectiveness outcomes were compared between patients with and without prior ischemic stroke/TIA. RESULTS: Among the patients, 2,153 (22.5%) had prior ischemic stroke/TIA. They were significantly older and had lower body weight, lower creatinine clearance, higher CHADS2, CHA2DS2-VASc, and modified HAS-BLED scores as compared to those without prior ischemic stroke/TIA. Any bleeding (9.1 vs. 7.2 events per 100 patient-years), major bleeding (2.3 vs. 1.6 events per 100 patient-years), and stroke/non-central nervous system systemic embolism/myocardial infarction (3.4 vs. 1.3 events per 100 patient-years) were more frequent in patients with prior ischemic stroke/TIA. Stepwise regression analysis suggested that body weight of ≤50 kg and diabetes mellitus were predictive of major bleeding in patients with prior ischemic stroke/TIA. CONCLUSIONS: Safety and effectiveness event rates were higher in patients with prior ischemic stroke/TIA than those without. This might be explained by differences in several risk profiles including age, body weight, renal function, and risk scores such as CHADS2 between the groups. Clinicaltrials.gov: NCT01582737.
Authors: Md Khalid Anwer; Muqtader Mohammad; Muzaffar Iqbal; Mohd Nazam Ansari; Essam Ezzeldin; Farhat Fatima; Saad M Alshahrani; Mohammed F Aldawsari; Ahmed Alalaiwe; Aiman A Alzahrani; Abdullah M Aldayel Journal: J Thromb Thrombolysis Date: 2020-04 Impact factor: 2.300