Association between once- and twice-daily direct oral anticoagulant adherence in nonvalvular atrial fibrillation patients and rates of ischemic stroke

2016 ◽  
Vol 215 ◽  
pp. 11-13 ◽  
Author(s):  
Mark J. Alberts ◽  
W. Frank Peacock ◽  
Larry E. Fields ◽  
Thomas J. Bunz ◽  
Elaine Nguyen ◽  
...  
2022 ◽  
pp. 174749302110577
Author(s):  
Jonathan G Best ◽  
Liz Arram ◽  
Norin Ahmed ◽  
Maryam Balogun ◽  
Kate Bennett ◽  
...  

Rationale Atrial fibrillation causes one-fifth of ischemic strokes, with a high risk of early recurrence. Although long-term anticoagulation is highly effective for stroke prevention in atrial fibrillation, initiation after stroke is usually delayed by concerns over intracranial hemorrhage risk. Direct oral anticoagulants offer a significantly lower risk of intracranial hemorrhage than other anticoagulants, potentially allowing earlier anticoagulation and prevention of recurrence, but the safety and efficacy of this approach has not been established. Aim Optimal timing of anticoagulation after acute ischemic stroke with atrial fibrillation (OPTIMAS) will investigate whether early treatment with a direct oral anticoagulant, within four days of stroke onset, is as effective or better than delayed initiation, 7 to 14 days from onset, in atrial fibrillation patients with acute ischemic stroke. Methods and design OPTIMAS is a multicenter randomized controlled trial with blinded outcome adjudication. Participants with acute ischemic stroke and atrial fibrillation eligible for anticoagulation with a direct oral anticoagulant are randomized 1:1 to early or delayed initiation. As of December 2021, 88 centers in the United Kingdom have opened. Study outcomes The primary outcome is a composite of recurrent stroke (ischemic stroke or symptomatic intracranial hemorrhage) and systemic arterial embolism within 90 days. Secondary outcomes include major bleeding, functional status, anticoagulant adherence, quality of life, health and social care resource use, and length of hospital stay. Sample size target A total of 3478 participants assuming event rates of 11.5% in the control arm and 8% in the intervention arm, 90% power and 5% alpha. We will follow a non-inferiority gatekeeper analysis approach with a non-inferiority margin of 2 percentage points. Discussion OPTIMAS aims to provide high-quality evidence on the safety and efficacy of early direct oral anticoagulant initiation after atrial fibrillation-associated ischemic stroke. Trial registrations: ISRCTN: 17896007; ClinicalTrials.gov: NCT03759938


2020 ◽  
Vol 61 (5) ◽  
pp. 905-912 ◽  
Author(s):  
Mihoko Kawabata ◽  
Masahiko Goya ◽  
Shingo Maeda ◽  
Atsuhiko Yagishita ◽  
Yoshihide Takahashi ◽  
...  

2018 ◽  
Vol 13 (8) ◽  
pp. 1144-1152 ◽  
Author(s):  
Jung-Im Shin ◽  
Alex Secora ◽  
G. Caleb Alexander ◽  
Lesley A. Inker ◽  
Josef Coresh ◽  
...  

Background and objectivesAll randomized trials of direct oral anticoagulants in atrial fibrillation excluded patients with severe kidney disease. The safety and effectiveness of direct oral anticoagulants across the range of eGFR in real-world settings is unknown. Our objective is to quantify the risk of bleeding and benefit of ischemic stroke prevention for direct oral anticoagulants compared with warfarin in patients with atrial fibrillation with and without CKD.Design, setting, participants, & measurementsWe created a propensity score–matched cohort of 3206 patients with atrial fibrillation and direct oral anticoagulant use and 3206 patients with atrial fibrillation using warfarin from October of 2010 to February of 2017 in an electronic health record (Geisinger Health System). The risks of bleeding and ischemic stroke were compared between direct oral anticoagulant and warfarin users using Cox proportional hazards regression, stratified by eGFR (≥60 and <60 ml/min per 1.73 m2).ResultsThe mean (SD) age of the 6412 participants was 72 (12) years, 47% were women, and average eGFR was 69 (21) ml/min per 1.73 m2. There were 1181 bleeding events and 466 ischemic strokes over 7391 person-years of follow-up. Compared with warfarin use, the hazard ratios (HRs) (95% confidence interval [95% CI]) of bleeding associated with direct oral anticoagulant use were 1.01 (0.88 to 1.17) and 1.23 (1.02 to 1.48) for those with eGFR≥60 and eGFR<60 ml/min per 1.73 m2, respectively (P-interaction=0.10). There was no difference between direct oral anticoagulant and warfarin users in the risk of ischemic stroke: HRs (95% CI) of 0.94 (0.74 to 1.18) and 1.02 (0.76 to 1.37) for those with eGFR≥60 and eGFR<60 ml/min per 1.73 m2, respectively (P-interaction=0.70). Similar findings were observed with individual drugs.ConclusionsIn a large health care system, patients with eGFR<60 ml/min per 1.73 m2 who took direct oral anticoagulants for atrial fibrillation had slightly higher risk of bleeding compared with those on warfarin, but similar benefits from prevention of ischemic stroke.


2018 ◽  
Vol 2018 ◽  
pp. 1-4
Author(s):  
Oreoluwa Oladiran ◽  
Jared Segal ◽  
Ifeanyi Nwosu ◽  
Salik Nazir

Rivaroxaban is a direct oral anticoagulant (DOAC) approved as an important alternative to warfarin in patients with nonvalvular atrial fibrillation. We report the case of an 87-year-old man with past medical history of nonvalvular atrial fibrillation on rivaroxaban and recently started amiodarone for pulseless ventricular tachycardia who presented to our hospital with intermittent chest pain and was diagnosed with spontaneous hemopericardium causing cardiac tamponade. The culprit drugs were discontinued, and the patient was treated with emergent pericardiocentesis. Both rivaroxaban and amiodarone are substrates for the CYP3A4 hepatic pathway, and concomitant use can result in increased plasma rivaroxaban levels causing an increased propensity to bleeding. While most physicians are cognizant of the need for renal dosing of rivaroxaban, this article aims to increase awareness of its interactions with drugs that are also metabolized through the same hepatic CYP450 pathway.


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