Abstract 63: Three-month Outcomes in Japanese Stroke /TIA Patients With Non-valvular Atrial Fibrillation After Initiating Oral Anticoagulants: The SAMURAI-NVAF Study

Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Shoji Arihiro ◽  
Kenichi Todo ◽  
Masatoshi Koga ◽  
Hiroshi Yamagami ◽  
Tadashi Terasaki ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Intracranial Hemorrhage ◽  
Recurrent Stroke ◽  
Oral Anticoagulants ◽  
Bleeding Events ◽  
Nonvalvular Atrial Fibrillation ◽  
Fatal Bleeding ◽  
Index Stroke ◽  
Ischemic Events

Backgound and Purpose: Recently, three non-vitamin K antagonist oral anticoagulants (NOACs) became available for patients with nonvalvular atrial fibrillation (NVAF) in Japan. We aimed to determine 3-month outcomes in ischemic stroke/TIA patients receiving NOACs or warfarin from a multicenter prospective registry (SAMURAI-NVAF registry, NCT01581502). Methods: Among 1,191 acute ischemic stroke /TIA patients enrolled between September 2011 and March 2014, we studied 916 patients (389 women, 77±10 y) who took oral anticoagulants (OACs) after index stroke and completed 3-month follow-up survey. Primary outcome measures were ischemic events, including recurrent stroke/TIA and thromboembolism, and major bleedings events, such as fatal bleeding and/or symptomatic bleeding in a critical area or organ according to the International Society on Thrombosis and Haemostasis statement. We assessed the incidence and clinical factors associated with primary outcomes within 90 days after initiating OACs. Results: NOACs were given for 370 patients (126 women, 74±9 y; dabigatran 168, rivaroxaban 183 and apixaban 19) and warfarin for 546 (263 women, 79±10 y). NOAC users had lower scores of CHADS2 (median 3 in NOAC, 4 in warfarin, p<0.001) and HAS-BLED (3, 3, p<0.001) than warfarin users. Ischemic events occurred in 14 NOAC users (3.8%; 2 women, 76±6 y, including 8 lower dose users between two approved dose for each NOAC) and 25 warfarin users (4.6%; 13 women, 81±9 y). Of these, 13 NOAC users (3.5%) and 16 warfarin users (2.9%) developed ischemic stroke/TIA. Among NOAC users, patients with ischemic events had lower body weights (53±11 vs 60±11kg, p= 0.017), more frequently had congestive heart failure (36 vs 10%, p = 0.003) and intracardiac thrombus (27 vs 4%, p < 0.001) than those without. Major bleeding events occurred in 5 NOAC users (1.4%, all using lower dose), and 14 warfarin users (2.6%). Of these, one NOAC user (0.3%) and 4 warfarin users (0.7%) developed intracranial hemorrhage. Conclusion: The 3-month incidence of ischemic events in stroke/TIA patients with NVAF was approximately 4% in both NOAC and warfarin users. Intracranial hemorrhage was relatively infrequent in NOAC users.

Abstract WMP115: Hemorrhagic and Ischemic Stroke in Patients on Oral Anticoagulants for Nonvalvular Atrial Fibrillation With and Without Antiplatelet Therapy

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Takeshi Morimoto ◽  
Norito Kinjo ◽  
Fumihiro Sakakibara ◽  
Kazutaka Uchida ◽  
Shinichiro Ueda
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Combination Therapy ◽  
Hemorrhagic Stroke ◽  
Oral Anticoagulants ◽  
Nonvalvular Atrial Fibrillation ◽  
Eligibility Criteria ◽  
Coronary Syndrome ◽  
All Cause Mortality ◽  
Ischemic Events

Introduction: Antiplatelet (APT) therapy is challenging in patients on oral anticoagulants (OACs) for nonvalvular atrial fibrillation (NVAF) who have coronary artery diseases (CAD). Analyzing large scale registry of consecutive patients with NVAF should provide further guide for the safety and efficacy of combination therapy. Methods: We conducted historical multicenter registry at 71 centers in Japan between March 2017 and March 2018. The eligibility criteria were patients on OACs for NVAF on February 2013. There were no exclusion criteria and consecutive patients who met the eligibility criteria were registered. All patients were followed until March 2017. Co-primary endpoints were ischemic strokes including transient ischemic attack and hemorrhagic stroke including subarachnoid hemorrhage. The secondary endpoints were all-cause mortality, ischemic events (acute coronary syndrome, ischemic strokes, or systemic embolism), and major bleedings defined by ISTH and TIMI criteria. We estimated HRs of OACs and APT combination relative to OACs alone by Cox proportional hazard model adjusting for clinically relevant confounders. Results: Median age was 74 (range 20-101) years of 7826 registered patients. Sustained NVAF accounted for 49% and 73% of patients had history of CAD. Cumulative incidences of ischemic stroke and hemorrhagic stroke at 4 years were 3.8% and 0.91% in No-APT group while 5.3% and 1.2% in APT group, respectively (Figure). Adjusted HRs (95%CI) of APT group for ischemic stroke and hemorrhagic stroke were 1.03 (0.76-1.40) and 1.27 (0.67-2.4), respectively. Adjusted HRs (95%CI) for all-cause mortality, ischemic events, and major bleedings were 0.98 (0.79-1.23), 0.98 (0.74-1.32), and 1.25 (1.00-1.57), respectively. Conclusions: Adding APT in patients on AOC for NVAF did not decrease ischemic strokes and not increase hemorrhagic strokes. Because combination therapy might increase the risk of major bleedings, OAC alone should be prioritized.

P4787Use of direct oral anticoagulants in patients with atrial fibrillation having a history of intracranial hemorrhage

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
T F Chao ◽  
S A Chen
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Intracranial Hemorrhage ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Research Database ◽  
Bleeding Events ◽  
Risk Of Mortality ◽  
Taiwan National Health Insurance ◽  
History Of

Abstract Background Patients with atrial fibrillation (AF) having a history of intracranial hemorrhage (ICH) were excluded from the pivotal randomized trials comparing direct oral anticoagulants (DOACs) and warfarin. We aimed to compare the effectiveness and safety of DOACs and warfarin among AF patients having a history of ICH. Method A total of 4,540 AF patients having a CHA2DS2-VASc score ≥1 for males and ≥2 for females who had a history of ICH and received oral anticoagulants (DOACs in 3,493 and warfarin in 1,047) were identified from the Taiwan National Health Insurance Research Database. A propensity matching analysis was performed to balance the baseline differences, and 973 patients were finally identified in each groups. Results The risk of ischemic stroke did not differ significantly between warfarin and DOACs (4.41%/yr vs 4.87%/yr; HR 0.985, p=0.927). The risks of bleeding events were lower with DOACs compared to warfarin with a HR (95% CI) of 0.752 (0.573–0.986, p=0.040) for major bleeding and 0.614 (0.379–0.995, p 0.048) for ICH. The risk of mortality was also lower in patients treated with DOACs (HR = 0.539; 95% CI = 0.453–0.642, p<0.001). The cumulative incidence curves of each events for 2 groups are shown in Figure. Conclusion Compared to warfarin, DOACs were associated with a similar risk of ischemic stroke and better safety profiles among AF patient with a history of ICH.

scholarly journals Effectiveness and Safety of Contemporary Oral Anticoagulants Among Asians With Nonvalvular Atrial Fibrillation

Stroke ◽  
2019 ◽  
Vol 50 (8) ◽  
pp. 2245-2249 ◽  
Author(s):  
So-Ryoung Lee ◽  
Eue-Keun Choi ◽  
Soonil Kwon ◽  
Kyung-Do Han ◽  
Jin-Hyung Jung ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Clinical Outcome ◽  
Gastrointestinal Bleeding ◽  
Intracranial Hemorrhage ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Asian Population ◽  
Nonvalvular Atrial Fibrillation ◽  
Observational Cohort

Background and Purpose— Limited evidence exists on the effectiveness and safety of warfarin and all 4 available non-vitamin K antagonist oral anticoagulants (NOACs) from current clinical practice in the Asian population with nonvalvular atrial fibrillation. We aimed to evaluate the comparative effectiveness and safety of warfarin and 4 NOACs. Methods— We studied a retrospective nonrandomized observational cohort of oral anticoagulant naïve nonvalvular patients with atrial fibrillation treated with warfarin or NOACs (rivaroxaban, dabigatran, apixaban, or edoxaban) from January 2015 to December 2017, based on the Korean Health Insurance Review and Assessment database. For the comparisons, warfarin to 4 NOACs and NOAC to NOAC comparison cohorts were balanced using the inverse probability of treatment weighting. Ischemic stroke, intracranial hemorrhage, gastrointestinal bleeding, major bleeding, and a composite clinical outcome were evaluated. Results— A total of 116 804 patients were included (25 420 with warfarin, 35 965 with rivaroxaban, 17 745 with dabigatran, 22 177 with apixaban, and 15 496 with edoxaban). Compared with warfarin, all NOACs were associated with lower risks of ischemic stroke, intracranial hemorrhage, gastrointestinal bleeding, major bleeding, and composite outcome. Apixaban and edoxaban showed a lower rate of ischemic stroke compared with rivaroxaban and dabigatran. Apixaban, dabigatran, and edoxaban had a lower rate of gastrointestinal bleeding and major bleeding compared with rivaroxaban. The composite clinical outcome was nonsignificantly different for apixaban versus edoxaban. Conclusions— In this large contemporary nonrandomized Asian cohort, all 4 NOACs were associated with lower rates of ischemic stroke and major bleeding compared with warfarin. Differences in clinical outcomes between NOACs may give useful guidance for physicians to choose drugs to fit their particular patient clinical profile.

scholarly journals Efficacy and Safety of Direct Oral Anticoagulants in Patients with Diabetes and Nonvalvular Atrial Fibrillation: Meta-Analysis of Observational Studies

2021 ◽  
Vol 2021 ◽  
pp. 1-14
Author(s):  
Bo Cao ◽  
Xingcan Yao ◽  
Lifang Zhang ◽  
Xiaobo Hu ◽  
Min Chen ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Observational Studies ◽  
Meta Analysis ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Efficacy And Safety ◽  
Nonvalvular Atrial Fibrillation ◽  
Patients With Diabetes

Background. This meta-analysis was performed to compare the efficacy and safety of direct oral anticoagulants (DOACs) with vitamin K antagonists (VKAs) for stroke prevention in real-world patients with diabetes and nonvalvular atrial fibrillation (NVAF) through observational studies. Methods. PubMed, Embase, and Web of Science databases were searched up to August 2020 for eligible studies. Outputs were presented as risk ratios (RRs) and corresponding 95% confidence intervals (CIs) by using a random-effect model. Results. Seven observational studies involving 249,794 diabetic NVAF patients were selected. Compared with VKAs, the use of DOACs was associated with significantly reduced risks of stroke ( RR = 0.56 , 95% CI 0.45-0.70; p < 0.00001 ), ischemic stroke ( RR = 0.61 , 95% CI 0.48-0.78; p < 0.0001 ), stroke or systemic embolism (SSE) ( RR = 0.81 , 95% CI 0.68-0.95; p = 0.01 ), myocardial infarction ( RR = 0.69 , 95% CI 0.55-0.88; p = 0.002 ), major bleeding ( RR = 0.75 , 95% CI 0.63-0.90; p = 0.002 ), intracranial hemorrhage ( RR = 0.50 , 95% CI 0.44-0.56; p < 0.00001 ), and major gastrointestinal bleeding ( RR = 0.77 , 95% CI 0.62-0.95; p = 0.02 ), and a borderline significant decrease in major adverse cardiac events ( RR = 0.87 , 95% CI 0.75-1.00; p = 0.05 ) in NVAF patients with diabetes. Conclusion. For patients with NVAF and diabetes in real-world clinical settings, DOACs showed superior efficacy and safety profile over VKAs and significantly reduced risks of stroke, ischemic stroke, SSE, myocardial infarction, major bleeding, intracranial hemorrhage, and major gastrointestinal bleeding.

scholarly journals Recurrent ischemic stroke in patients with atrial fibrillation: frequency, heterogeneity, prevention

2020 ◽  
pp. 7-16
Author(s):  
L. A. Geraskina ◽  
M. M. Alieva ◽  
A. V. Fonyakin ◽  
M. Yu. Maximova ◽  
N. I. Garabova ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Recurrent Stroke ◽  
Dynamic Assessment ◽  
Oral Anticoagulants ◽  
Antiplatelet Agents ◽  
Antithrombotic Agent ◽  
Retrospective Assessment ◽  
Prevention Therapy

Introduction. For the prevention of recurrent ischemic stroke (IS) in patients with atrial fibrillation (AF), oral anticoagulants (OAC) are considered a priority. The comorbidity of AF patients raises a discussion about the non-alternative feasibility and exceptional clinical efficacy of OAC. The validity of the choice of a specific antithrombotic agent can be assessed using a dynamic assessment of the causes of the first and recurrent stroke in patients with AF.Aim. To assess the frequency recurrent IS and quality of medicament prevention therapy in patients with AF depend on heterogeneity of stroke leading pathogenetic mechanism.Materials and methods. The data from the register of 200 patients with IS and AF were analyzed. 55 (27.5%) patients suffered recurrent IS (24 (43,6%) men, 31 (56,4%) women, mean age 72,3 ± 10,2 years). The pathogenetic subtype of recurrent IS was determined, including a retrospective assessment of the pathogenetic subtype of a previous IS. We studied the presence and nature of antithrombotic therapy (ATT) preceding a second stroke.Results. The first IS was due to cardiogenic embolism in 36.4% of patients, the atherothrombotic subtype occurred in 18.2%, and the lacunar subtype in 34.5% of patients. Embolic stroke from an undetermined source (ESUS) - in 10.9% of patients. OACs were prescribed only to 31.7% of patients, antiplatelet agents - to 14.6% of patients, 53.7% of patients did not receive ATT. The leading pathogenetic subtype of recurrent stroke was cardiogenic embolism (70.7%), the frequency of lacunar stroke decreased (4.9%), and the frequency of atherothrombotic stroke remained unchanged. In 14 patients with recurrent stroke, AF was first detected, including all patients with ESUS.Conclusion. The proportion of recurrent stroke in patients with AF is 27.5%. Compared with the first stroke, recurrent stroke in patients with AF is characterized by an increase in the proportion of cardiogenic embolism up to 70.7%, which is due to the insufficient prescription of OAC, which must be recommended, including for patients with non-cardioembolic subtypes of stroke.

scholarly journals Early Initiation of Direct Oral Anticoagulants After Onset of Stroke and Short- and Long-Term Outcomes of Patients With Nonvalvular Atrial Fibrillation

Stroke ◽  
2020 ◽  
Vol 51 (3) ◽  
pp. 883-891 ◽  
Author(s):  
Tadataka Mizoguchi ◽  
Kanta Tanaka ◽  
Kazunori Toyoda ◽  
Sohei Yoshimura ◽  
Ryo Itabashi ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Hazard Ratio ◽  
Interquartile Range ◽  
Systemic Embolism ◽  
Nonvalvular Atrial Fibrillation ◽  
Ischemic Attack

Background and Purpose— We aimed to compare outcomes of ischemic stroke patients with nonvalvular atrial fibrillation between earlier and later initiation of direct oral anticoagulants (DOACs) after stroke onset. Methods— From data for 1192 nonvalvular atrial fibrillation patients with acute ischemic stroke or transient ischemic attack in a prospective, multicenter, observational study, patients who started DOACs during acute hospitalization were included and divided into 2 groups according to a median day of DOAC initiation after onset. Outcomes included stroke or systemic embolism, major bleeding, and death at 3 months, as well as those at 2 years. Results— DOACs were initiated during acute hospitalization in 499 patients in median 4 (interquartile range, 2–7) days after onset. Thus, 223 patients (median age, 74 [interquartile range, 68–81] years; 78 women) were assigned to the early group (≤3 days) and 276 patients (median age, 75 [interquartile range, 69–82] years; 101 women) to the late (≥4 days) group. The early group had lower baseline National Institutes of Health Stroke Scale score and smaller infarcts than the late group. The rate at which DOAC administration persisted at 2 years was 85.2% overall, excluding patients who died or were lost to follow-up. Multivariable Cox shared frailty models showed comparable hazards between the groups at 2 years for stroke or systemic embolism (hazard ratio, 0.86 [95% CI, 0.47–1.57]), major bleeding (hazard ratio, 1.39 [95% CI, 0.42–4.60]), and death (hazard ratio, 0.61 [95% CI, 0.28–1.33]). Outcome risks at 3 months also did not significantly differ between the groups. Conclusions— Risks for events including stroke or systemic embolism, major bleeding, and death were comparable whether DOACs were started within 3 days or from 4 days or more after the onset of nonvalvular atrial fibrillation–associated ischemic stroke or transient ischemic attack. Registration— URL: https://www.clinicaltrials.gov . Unique identifier: NCT01581502.

Abstract 159: Evaluation of Clinical Outcomes among Nonvalvular Atrial Fibrillation Patients Treated With Warfarin or Rivaroxaban Stratified by Presence or Absence of CKD in a Claims Database

2017 ◽  
Vol 10 (suppl_3) ◽  
Author(s):  
Matthew R Weir ◽  
Lloyd Haskell ◽  
Jeffrey S Berger ◽  
Veronica Ashton ◽  
François Laliberté ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Major Bleeding ◽  
Bleeding Event ◽  
Data Availability ◽  
Thromboembolic Events ◽  
Bleeding Events ◽  
Nonvalvular Atrial Fibrillation ◽  
Claims Database ◽  
Increased Risk

Introduction: Renal functional impairment is linked to an increased risk of thromboembolic and bleeding events in patients with nonvalvular atrial fibrillation (NVAF) treated with warfarin and rivaroxaban. Anticoagulants such as warfarin and rivaroxaban are often recommended to reduce the risk of stroke in NVAF patients. The purpose of this study was to evaluate and compare thromboembolic and bleeding event rates for warfarin and rivaroxaban patients stratified by presence of chronic kidney disease (CKD). Methods: Claims from the IMS Health Real-World Data Adjudicated Claims database from 05/2011-6/2015 were analyzed. Adult patients with NVAF who had ≥6 months of baseline data prior to the first dispensing of warfarin or rivaroxaban after 11/2011 were included. Patients were followed until the end of index therapy or end of data availability/insurance coverage. Outcomes were stratified by presence of CKD for ischemic stroke, major bleeding, and a composite measure of thromboembolic events (ischemic stroke, myocardial infarction (MI) or venous thromboembolism (VTE)) and analyzed using hazard ratios (HRs). Adjustments for confounding were made with inverse probability of treatment weights (IPTW). Results: The analysis included 39,872 rivaroxaban (9.0% [3,572 of 39,872] with CKD) and 48,637 warfarin patients (16.9% [8,230 of 48,637] with CKD). As expected, thromboembolic and bleeding events were more common in patients with CKD than those without CKD. Rivaroxaban patients had significantly lower risk of ischemic stroke, both in the overall population (HR = 0.79 [0.68-0.90], p=0.0008) and for those with CKD (HR = 0.55 [0.40-0.77], p=0.0004). A composite of thromboembolic events were lower with rivaroxaban irrespective of CKD. Major bleeding rates were comparable across all groups. Table 1 reports incidence rates and HRs stratified by presence of CKD. Conclusions: This study suggests that, in an adult population with NVAF, rivaroxaban-treated patients had fewer ischemic strokes across all patients, including patients with renal impairment. Rivaroxaban-treated patients also had significantly better outcomes for the composite (VTE, MI, or stroke) measure across all groups. Bleeding rates were comparable across all groups.

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