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Rivaroxaban as an oral anticoagulant for stroke prevention in atrial fibrillation.

ABSTRACT: Atrial fibrillation (AF) is the most common cardiac arrhythmia in the developed world and is associated with a fivefold increase in the risk of stroke, accounting for up to 15% of strokes in the general population. The European Society of Cardiology now recommends direct oral anticoagulants, such as rivaroxaban, apixaban, and dabigatran, in preference to vitamin K antagonist therapy for the prevention of stroke in patients with A F. This review focuses on the direct Factor Xa inhibitor rivaroxaban, summarizing the properties that make rivaroxaban appropriate for anticoagulant therapy in this indication (including its predictable pharmacokinetic and pharmacodynamic profile and once-daily dosing regimen) and describing data from the Phase III ROCKET AF trial, which showed once-daily rivaroxaban to be noninferior to warfarin for the prevention of stroke in patients with nonvalvular AF. In this trial, similar rates of major and nonmajor clinically relevant bleeding were observed; however, when compared with warfarin, rivaroxaban was associated with clinically significant reductions in intracranial and fatal bleeding. On the basis of these results, rivaroxaban was approved in both the United States and the European Union for the prevention of stroke and systemic embolism in patients with nonvalvular AF. Subanalyses of ROCKET AF data showed rivaroxaban to have consistent efficacy and safety across a wide range of patients, and studies to confirm these results in real-world settings are underway. This review also describes practical considerations for treatment with rivaroxaban in clinical practice (including dose reductions in specific high-risk patients, eg, those with renal impairment), recommendations for the transition from vitamin K antagonists to rivaroxaban, the management of bleeding events, and the measurement of rivaroxaban exposure.

SUBMITTER: Turpie AG

PROVIDER: S-EPMC3968084 | biostudies-other | 2014

REPOSITORIES: biostudies-other

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Rivaroxaban as an oral anticoagulant for stroke prevention in atrial fibrillation.

Turpie Alexander Gg AG

Therapeutics and clinical risk management 20140322

Atrial fibrillation (AF) is the most common cardiac arrhythmia in the developed world and is associated with a fivefold increase in the risk of stroke, accounting for up to 15% of strokes in the general population. The European Society of Cardiology now recommends direct oral anticoagulants, such as rivaroxaban, apixaban, and dabigatran, in preference to vitamin K antagonist therapy for the prevention of stroke in patients with A F. This review focuses on the direct Factor Xa inhibitor rivaroxab ...[more]

PMID: 24711702

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Project description:ObjectiveTo do an indirect comparison analysis of apixaban against dabigatran etexilate (2 doses) and rivaroxaban (1 dose), as well as of rivaroxaban against dabigatranetexilate (2 doses), for their relative efficacy and safety against each other, with particular focus on the secondary prevention population for stroke prevention in atrial fibrillation. A secondary objective was to do the same analysis in the primary prevention cohort.DesignIndirect treatment comparisons of phase III clinical trials of stroke prevention in atrial fibrillation, with a focus on the secondary prevention cohorts. A secondary analysis was done on the primary prevention cohort.Data sourcesMedline and Central (up to June 2012), clinical trials registers, conference proceedings, and websites of regulatory agencies.Study selectionRandomised controlled trials of rivaroxaban, dabigatran, or apixaban compared with warfarin for stroke prevention in atrial fibrillation.ResultsIn the secondary prevention (previous stroke) subgroup, when apixaban was compared with dabigatran (110 mg and 150 mg twice daily) for efficacy and safety endpoints, the only significant difference seen was less myocardial infarction (hazard ratio 0.39, 95% confidence interval 0.16 to 0.95) with apixaban compared with dabigatran 150 mg twice daily. No significant differences were seen in efficacy and most safety endpoints between apixaban or dabigatran 150 mg twice daily versus rivaroxaban. Less haemorrhagic stroke (hazard ratio 0.15, 0.03 to 0.66), vascular death (0.64, 0.42 to 0.99), major bleeding (0.68, 0.47 to 0.99), and intracranial bleeding (0.27, 0.10 to 0.73) were seen with dabigatran 110 mg twice daily versus rivaroxaban. In the primary prevention (no previous stroke) subgroup, apixaban was superior to dabigatran 110 mg twice daily for disabling or fatal stroke (hazard ratio 0.59, 0.36 to 0.97). Compared with dabigatran 150 mg twice daily, apixaban was associated with more stroke (hazard ratio 1.45, 1.01 to 2.08) and with less major bleeding (0.75, 0.60 to 0.94), gastrointestinal bleeding (0.61, 0.42 to 0.89), and other location bleeding (0.74, 0.58 to 0.94). Compared with rivaroxaban, dabigatran 110 mg twice daily was associated with more myocardial infarction events. No significant differences were seen for the main efficacy and safety endpoints between dabigatran 150 mg twice daily and rivaroxaban, or in efficacy endpoints between apixaban and rivaroxaban. Apixaban was associated with less major bleeding (hazard ratio 0.61, 0.48 to 0.78) than rivaroxaban.ConclusionsFor secondary prevention, apixaban, rivaroxaban, and dabigatran had broadly similar efficacy for the main endpoints, although the endpoints of haemorrhagic stroke, vascular death, major bleeding, and intracranial bleeding were less common with dabigatran 110 mg twice daily than with rivaroxaban. For primary prevention, the three drugs showed some differences in relation to efficacy and bleeding. These results are hypothesis generating and should be confirmed in a head to head randomised trial.

Project description:It is not known whether patients with atrial fibrillation (AF) with ischemic stroke despite oral anticoagulant therapy are at increased risk for further recurrent strokes or how ongoing secondary prevention should be managed. We conducted an individual patient data pooled analysis of 7 prospective cohort studies that recruited patients with AF and recent cerebral ischemia. We compared patients taking oral anticoagulants (vitamin K antagonists [VKA] or direct oral anticoagulants [DOAC]) prior to index event (OACprior ) with those without prior oral anticoagulation (OACnaive ). We further compared those who changed the type (ie, from VKA or DOAC, vice versa, or DOAC to DOAC) of anticoagulation (OACchanged ) with those who continued the same anticoagulation as secondary prevention (OACunchanged ). Time to recurrent acute ischemic stroke (AIS) was analyzed using multivariate competing risk Fine-Gray models to calculate hazard ratios (HRs) and 95% confidence intervals (CIs). We included 5,413 patients (median age = 78 years [interquartile range (IQR) = 71-84 years]; 5,136 [96.7%] had ischemic stroke as the index event, median National Institutes of Health Stroke Scale on admission = 6 [IQR = 2-12]). The median CHA2 DS2 -Vasc score (congestive heart failure, hypertension, age≥ 75 years, diabetes mellitus, stroke/transient ischemic attack, vascular disease, age 65-74 years, sex category) was 5 (IQR = 4-6) and was similar for OACprior (n = 1,195) and OACnaive (n = 4,119, p = 0.103). During 6,128 patient-years of follow-up, 289 patients had AIS (4.7% per year, 95% CI = 4.2-5.3%). OACprior was associated with an increased risk of AIS (HR = 1.6, 95% CI = 1.2-2.3, p = 0.005). OACchanged (n = 307) was not associated with decreased risk of AIS (HR = 1.2, 95% CI = 0.7-2.1, p = 0.415) compared with OACunchanged (n = 585). Patients with AF who have an ischemic stroke despite previous oral anticoagulation are at a higher risk for recurrent ischemic stroke despite a CHA2 DS2 -Vasc score similar to those without prior oral anticoagulation. Better prevention strategies are needed for this high-risk patient group. ANN NEUROL 2020.

Project description:BackgroundAtrial fibrillation detected after stroke (AFDAS) has a lower risk of ischemic stroke recurrence than known atrial fibrillation (KAF). While the benefit of oral anticoagulants (OAC) for preventing ischemic stroke recurrence in KAF is well established, their role in patients with AFDAS is more controversial. This study aimed to evaluate the association between OAC use and the risk of recurrent ischemic stroke in patients with AFDAS in a real-world setting.MethodsThis nationwide retrospective cohort study was conducted using the Taiwan National Health Insurance Research Database. Patients hospitalized with a first-ever ischemic stroke and AFDAS confirmed within 30 days after hospitalization were assigned to OAC and non-OAC cohorts. Inverse probability of treatment weighting was applied to balance the baseline characteristics of the cohorts. The primary outcome was ischemic stroke recurrence. Secondary outcomes were intracranial hemorrhage (ICH), death, and the composite outcome of "ischemic stroke recurrence, ICH, or death." Multivariate Cox proportional hazard models were used to estimate adjusted hazard ratios (aHR) and 95% confidence intervals (CI).ResultsA total of 4,508 hospitalized patients with stroke and AFDAS were identified. Based on OAC use, 2,856 and 1,652 patients were assigned to the OAC and non-OAC groups, respectively. During the follow-up period (median duration, 2.76 years), the OAC cohort exhibited a lower risk of ischemic stroke recurrence (aHR, 0.84; 95% CI, 0.70-0.99), death (aHR, 0.65; 95% CI, 0.58-0.73), and composite outcome (aHR, 0.70; 95% CI, 0.63-0.78) than did the non-OAC cohort. The risk of ICH (aHR, 0.96; 95% CI, 0.62-1.50) was not significantly different between the two cohorts.ConclusionOAC use in patients with AFDAS was associated with reduced risk of ischemic stroke recurrence, without an increased risk of ICH. This supports current guidelines recommending OACs for secondary stroke prevention in patients with AF, regardless of the time of diagnosis.

Dataset Information

Rivaroxaban as an oral anticoagulant for stroke prevention in atrial fibrillation.

Publications

Rivaroxaban as an oral anticoagulant for stroke prevention in atrial fibrillation.

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