[Stroke prevention in patients with atrial fibrillation].
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Oral anticoagulation with vitamin K antagonists (VKA) was the cornerstone of stroke prevention in atrial fibrillation (AF). This review article presents the state of the art, with regard to the treatment options developed over the past few years, the new oral anticoagulants (NOAC). A search in PubMed for relevant published studies has been performed. Dabigatran and apixaban were superior to warfarin to reduce stroke risk or systemic embolism ; dabigatran, rivaroxaban and edoxaban were non-inferior. All NOAC are globally non-inferior to warfarin for stroke prevention in non-valvular AF and they have a superior safety profile, with a reduced intracranial bleeding risk. They are now the first choice for treatment.Les antagonistes de la vitamine K (AVK) ont été pendant longtemps la référence comme prévention de l’accident vasculaire cérébral (AVC) chez les patients souffrant de fibrillation auriculaire (FA). Cet article de revue propose une mise à jour des options thérapeutiques développées ces dernières années, à savoir les nouveaux anticoagulants oraux (NACO). Une recherche des études pertinentes a été effectuée dans PubMed. Il apparaît ainsi que le dabigatran et l’apixaban sont supérieurs à la warfarine pour réduire les AVC et les embolies systémiques ; le dabigatran, le rivaroxaban et l’édoxaban sont non inférieurs. Tous les NACO sont donc globalement non inférieurs à la warfarine pour prévenir les AVC dans la FA non valvulaire et ils ont un profil de sécurité supérieur, avec un moindre risque d’hémorragie intracrânienne. Ils représentent maintenant le traitement de premier choix.Keywords:
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Abstract: Atrial fibrillation is the most common arrhythmia in the elderly. It is responsible for significant morbidity and mortality from cardioembolic complications like stroke. As a result, atrial fibrillation patients are risk-stratified using the CHADS 2 or CHA 2 DS 2 -VASc scoring systems. Those at intermediate-to-high risk have traditionally been treated with therapeutic anticoagulation with warfarin for stroke prevention. Although effective, warfarin use is fraught with multiple concerns, such as a narrow therapeutic window, drug–drug and drug–food interactions, and excessive bleeding. Novel oral anticoagulant agents have recently become available as viable alternatives for warfarin therapy. Direct thrombin inhibitor dabigatran and factor Xa inhibitors like rivaroxaban and apixaban have already been approved by the US Food and Drug Administration (FDA) for stroke prevention in patients with nonvalvular atrial fibrillation. Edoxaban is the latest oral direct factor Xa inhibitor studied in the largest novel oral anticoagulant trial so far: ENGAGE AF-TIMI 48. Treatment with a 30 mg or 60 mg daily dose of edoxaban was found to be noninferior to dose-adjusted warfarin in reducing the rate of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, with a lower incidence of bleeding complications and cardiovascular deaths. Edoxaban was recently reviewed by an FDA advisory committee and recommended as a stroke-prophylaxis agent. Once approved, it promises to provide another useful alternative to warfarin therapy. Keywords: atrial fibrillation, stroke prevention, novel oral anticoagulants, factor Xa inhibitors, edoxaban
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T he rate of stroke among adults with atrial fibrilla- tion (AF) varies widely, ranging between 1% and 20% annually (mean 4.5% per year) depending on comorbidities and a patient's history of prior cerebrovascular events. 1 Stratification of stroke risk is important, because the major risk of antithrombotic medications used to lower the incidence of AF-related stroke is bleeding.2][3] The advent of several new antithrombotic agents offers alternatives to warfarin and may lower the threshold for thromboembolic risk for initiating therapy in patients with AF.In this update to the American Heart Association/ American Stroke Association (AHA/ASA) "Guidelines for the Primary Prevention of Stroke" 4 and the prevention of stroke in patients with stroke or transient ischemic attack (TIA), 5 we review recent trials testing the safety and efficacy of a thrombin inhibitor (dabigatran) and 2 factor Xa inhibitors (rivaroxaban and apixaban) in preventing stroke in patients with AF, and we revise management recommendations. 4,5Recommendations follow the AHA's and the American College of Cardiology's methods of classifying the level of certainty of the treatment effect and the class of evidence (Table 1). Summary of Current AHA/ASA Guidelines for Vitamin K Antagonists/Antithrombotics inPatients With AF Risk StratificationThe absolute risk of stroke varies 20-fold among AF patients according to age and associated vascular comorbidities.7][8] These, however, can yield differing results. 9Current AHA guidelines use the CHADS 2 stratification scheme 7 (CHADS 2 is an acronym for Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, and prior Stroke or TIA).The CHADS 2 score was derived from independent predictors of stroke risk in patients with nonvalvular AF. 7 The score assigns 1 point each for congestive heart failure, hypertension, age ≥75 years, and diabetes mellitus and 2 points for prior stroke or TIA. 7The score was validated in a large cohort study and in clinical trials. 6,10For Oral Antithrombotic Agents for the Prevention of Stroke in Nonvalvular Atrial Fibrillation
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Atrial fibrillation(AF)is a strong risk factor for ischemic cerebral stroke.Some inherent defects of Warfarin limit its clinic application,which accelerates research and development of new oral anticoagulants,such as Dabigatran,Apixaban,Rivaroxaban and Edoxaban etc..This article made an overview for these.
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No studies have directly compared the effectiveness and safety of direct oral anticoagulants (DOACs) and warfarin among patients with and without history of ischemic stroke and transient ischemic attack (TIA) using Medicare data. This is important since patients with atrial fibrillation (AF) and previous ischemic stroke or TIA have a particularly high risk of stroke.
Using 2012-2014 Medicare Part D data, we identified patients newly diagnosed with AF in 2013-2014 who initiated apixaban (n=2358), dabigatran (n=1415), rivaroxaban (n=5139), or warfarin (n=12,352). We categorized them according to history of stroke or TIA. Primary outcomes included ischemic stroke as a measure of effectiveness and bleeding as a measure of safety. We constructed Cox proportional hazard models including indicator variables for treatment, a history of stroke or TIA, and the interaction between treatment and clinical history, adjusted for demographics and clinical characteristics.
DOACs were more effective than warfarin for stroke prevention overall; however, the superiority of dabigatran was more pronounced in patients with a history of stroke or TIA: the hazard ratio (HR) for ischemic stroke with dabigatran compared to warfarin was 0.64(95%CI 0.48-0.85) for patients with a history of stroke or TIA, and was 0.94 (95%CI 0.75-1.16) for patients with no history of stroke or TIA (interaction p-value =0.034). Although there was no difference in the risk of stroke between apixaban and dabigatran (HR 0.94; 95%CI 0.71-1.24) or between apixaban and rivaroxaban (HR 1.01; 95%CI, 0.81-1.27) for patients with no history of stroke or TIA, the risk of ischemic stroke was lower with dabigatran (HR 0.61;95%CI 0.44-0.85) and with rivaroxaban (HR 0.70; 95%CI 0.56-0.87) in patients with a history of stroke or TIA compared to apixaban (both interaction p-values<0.05). The comparative safety of DOACs and warfarin did not differ between patients with and without a history of stroke or TIA.
The comparative effectiveness of DOACs differs substantially between patients with and without a history of stroke or TIA; specifically, apixaban is less effective in patients with a history of stroke or TIA. Our results reinforce the need to tailor anticoagulation to AF patient characteristics regarding the public health significance of stroke prevention.
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Warfarin has been the effective treatment in the prophylaxis of cardioembolism, in particular in patients with atrial fibrillation, for more than 50 years. Nevertheless, many patients with atrial fibrillation are not currently treated because of the numerous limits of oral anticoagulation and in those treated the quality of anticoagulation is often poor. Novel oral anticoagulant drugs, the direct thrombin antagonist dabigatran and factor Xa inhibitors such as rivaroxaban, apixaban, edoxaban, and betrixaban are more predictable and convenient anticoagulants in comparison with warfarin, mainly because of the non-requirement of regular laboratory monitoring and dose adjustments. Current data from phase III clinical trials are available for dabigatran, rivaroxaban and apixaban, which show to be at least noninferior in efficacy to warfarin for the prevention of stroke in patients with atrial fibrillation. This review focuses on the potential of novel anticoagulants to replace warfarin in patients with atrial fibrillation. Also the place in therapy and the potential limitations of the new agents in clinical practice represent important issues to be considered. The promise of new oral anticoagulants gives us the hope that warfarin will finally be replaced in a near future, but more importantly that anticoagulant undertreatment of atrial fibrillation will be partially overcome.
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Oral anticoagulation (OAC) remains the mainstay for prevention of ischaemic stroke in atrial fibrillation. This article reviews the latest evidence and development of new oral anticoagulants for the prevention of ischaemic stroke, as well as bleeding risk assessment, mitigation and management.Decision-making for stroke prevention has evolved towards the initial identification of 'low-risk' patients who do not need any antithrombotic therapy. Subsequent to this step, patients with at least 1 stroke risk factor can be offered effective stroke prevention, which is OAC. There is increased morbidity and mortality amongst warfarin users, if time in therapeutic range is poor. New oral anticoagulants (such as dabigatran, rivaroxaban, apixaban and edoxaban) offer relative efficacy, safety and convenience compared to warfarin, in relation to stroke prevention in atrial fibrillation. Bleeding risk can be assessed by HAS-BLED score, whereas the new SAMe-TT2R2 score can predict the patient's suitability for vitamin K antagonists.The landscape for stroke prevention in atrial fibrillation has greatly changed. It is no longer a question of 'if we treat' but more of 'how to treat', as the presence of one or more stroke risk factors in atrial fibrillation confers a risk of fatal and devastating strokes. OAC use, whether as well controlled vitamin K antagonists or nonvitamin K antagonists oral anticoagulant, will reduce the burden of stroke in atrial fibrillation.
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To analyse clinical outcomes with direct oral anticoagulants in patients with atrial fibrillation according to geographic region.We systematically searched MEDLINE, CENTRAL, websites of regulatory agencies, clinical trials registers and conference proceedings for randomized controlled trials of direct oral anticoagulants (DOAC: dabigatran, rivaroxaban, apixaban or edoxaban) against warfarin for prophylaxis of stroke and systemic embolic events (SEE) in patients with atrial fibrillation (AF). Two investigators independently extracted data. Relative risks of stroke and SEE as well as major bleeding depending on geographic region were estimated using a random effect meta-analysis.Five trials in 72 963 patients were analysed; 32 089 (44%) patients were recruited in Europe (Western Europe: 13 676; Eastern Europe: 18 413). We found significant subgroup differences for stroke/SEE depending on the geographic region (interaction P = 0.003; I(2) 88.5%), with a neutral effect of the DOAC vs. warfarin in Europe [relative risk (RR) 0.97, 95% confidence interval (CI) 0.85-1.11, I(2) 0%] and a significant reduction of stroke/SEE in other regions including North America, Latin America and Asia-Pacific/other (RR 0.72, 95% CI 0.63-0.83, I(2) 33%). There was a similar reduction in risk of major bleeding in Europe (RR 0.82, 95% CI 0.73-0.92, I(2) 0%) and in other regions (RR 0.86, 95% CI 0.72-1.02, I(2) 78%).The DOAC did not provide additional benefit in reducing the risk of stroke/SEE compared with warfarin in European patients with AF, but were generally associated with a lower bleeding tendency than warfarin regardless of geographic region.
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The prevalence of atrial fibrillation is lower in females than in men, but the risk of stroke and systemic thromboembolism is comparable or even higher. Administration of anticoagulant therapy does not modify this difference. Two classes of non-vitamin K antagonist oral anticoagulants were studied in atrial fibrillation: direct thrombin inhibitors, like Dabigatran, and activated factor X inhibitors, like Rivaroxaban, Apixaban and Edoxaban. Response to oral anticoagulants could differ between the gender. This medication was evaluated in phase III randomized controlled trials. Non-vitamin K antagonist oral anticoagulants have been proved more efficacious than Warfarin for stroke and systemic embolism prevention in women, but conclusions regarding the safety and the bleeding are heterogeneous. As in men, before prescribing a NOAC to a female with AF, the stroke and the bleeding risk have to be carefully estimated. It is important that future studies to be targeted on comparison between of non-vitamin K antagonist oral anticoagulants versus Warfarin in females with non-valvular atrial fibrillation.
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