1,724,979 research outputs found

    Dabigatran in clinical practice: Contemporary overview of the evidence

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    Oral anticoagulation is the cornerstone of stroke prevention in non-valvular atrial fibrillation (AF) and management of venous thromboembolism (VTE), resulting in a reduction in thrombotic complications and mortality. Benefit of vitamin K antagonists (VKAs) in such patients has been unambiguously confirmed, but VKA use is complicated by need for regular monitoring of the international normalized ratio and multiple drug and food interactions. Dabigatran is an oral direct thrombin inhibitor that can be used with fixed doses, without the need for routine anticoagulation laboratory monitoring and the advantage of few drug or diet interactions. Dabigatran is effective for stroke and systemic thromboembolism in AF and for the prophylaxis and treatment of VTE. The drug has a good safety profile and consistently shows a reduction in intracranial hemorrhage risk compared to warfarin. A specific reversal agent for dabigatran has been approved by FDA and EU. This review provides a summary of publications assessing clinical utility of dabigatran for different indications

    Antidotes to non-vitamin K oral anticoagulants: Necessary or not?

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    In the last few years, a new category of anticoagulants have been developed, the non-vitamin K oral anticoagulants (NOACs). The NOACs are of two classes: the direct thrombin inhibitor, namely dabigatran etexilate; and the oral factor Xa inhibitors rivaroxaban, apixaban and edoxaban, which have been proven to be as effective and safe (and sometimes, superior) compared to warfarin in the treatment of both atrial fibrillation (AF) and venous thromboembolism (VTE). One major concern about their use has always been the lack of an effective antidote or reversal strategy. The objective of this editorial is to provide an overview of the characteristics of NOAC antidotes that are in development. Moreover, we review their likely place in the management of NOAC-related bleeding episodes

    Atrial Fibrillation and Stroke: Making Sense of Recent Observations on Anticoagulation

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    Atrial fibrillation (AF) is the most prevalent heart rhythm disorder. AF accounts for a great proportion of deaths because it independently increases all-cause mortality and cardiovascular mortality risks. Ischemic stroke is the most common cardiovascular adverse event in AF patients. Oral anticoagulation (OAC) therapy with vitamin K antagonists (VKA) has been central for stroke prevention. Several drugs with a direct inhibitory effects on thrombin and factor Xa have been developed. These non-vitamin K antagonist oral anticoagulants (NOACs) are as effective and safer than warfarin. This review provides an overview of current guidelines and summarizes current evidence for the prevention of stroke in AF patients according to most relevant patients' subgroups and clinical features

    Major Outcomes in Atrial Fibrillation Patients with One Risk Factor: Impact of Time in Therapeutic Range

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    BACKGROUND: The benefits and harms of oral anticoagulation (OAC) therapy in patients with only one stroke risk factor (i.e. CHA2DS2-VASc= 1 in males, or 2 in females) has been subject of debate. METHODS: We analysed all patients with only one stroke risk factor from the merged datasets of SPORTIF III and V trials. Anticoagulation control was defined according to time in therapeutic range (TTR). RESULTS: Of the original trial cohort, 1,097 patients had only one stroke risk factor. Stroke/systemic thromboembolic event had an incidence of 0.9 per 100 patient-years, with an incidence of 1.6 per 100 patient-years for all-cause death and 2.3%/patient-years for the composite outcome of stroke/systemic thromboembolic event/all-cause death. There were no significant differences in the risk for stroke/systemic thromboembolic event between sexes, nor between the different stroke risk factors amongst these atrial fibrillation patients with only one stroke risk factor. Cox regression analysis in patients treated with warfarin only found TTR to be inversely associated with stroke/systemic thromboembolic event (p=0.034) and all-cause death (p=0.015). Chronic heart failure was significantly associated with the outcome of all-cause death (p=0.0019) and the composite outcome of stroke/systemic thromboembolic event/all-cause death (p=0.021). There was a significant inverse linear association between TTR and the cumulative risk for both stroke/systemic thromboembolic event and all-cause death (both p<0.001). CONCLUSIONS: In atrial fibrillation patients with only one additional stroke risk factor (i.e. CHA2DS2-VASc= 1 in males or 2 in females), rates of major adverse events (stroke/systemic thromboembolic event, mortality) were high, despite anticoagulation. TTR in warfarin-treated patients was inversely associated with the occurrence of both stroke/systemic thromboembolic event and all-cause death

    Quality indicators in the management of elderly Chinese patients with atrial fibrillation:A report from the Optimal Thromboprophylaxis in Elderly Chinese Patients with Atrial Fibrillation (ChiOTEAF) registry

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    Aims To evaluate the quality measures and clinical performance indicators among elderly Chinese patients with atrial fibrillation (AF). The management of patients with AF requires a holistic, multidisciplinary approach. Quality indicators have been proposed to assess the quality of care in ‘real-world’ clinical practice when managing patients with AF. Methods and The Optimal Thromboprophylaxis in Elderly Chinese Patients with Atrial Fibrillation (ChiOTEAF) registry is a prospecresults tive, observational, large-scale multicentre registry conducted between October 2014 and December 2018 in China. Data were collected at the enrolment and during the follow-up visits by the local investigators. In the ChiOTEAF registry, 14 primary and 8 secondary indicators from six domains of care were assessed. Six thousand four hundred twenty patients who completed the 1-year follow-up were included in the analysis. Median age was 76 years, and the majority of patients was male (60.8%). Overall, 3246 patients (54.8%) were not treated with oral anticoagulants (OACs) appropriate to their risk of stroke; specifically, among those at highest risk of stroke, OACs were prescribed in only 43.3% patients (1258/2905). Among patients with permanent AF, 32 (3.6%) were prescribed antiarrhythmic drugs, and among those with paroxysmal AF, catheter ablation was performed in 20.7%. Patients were overburdened with multi-morbidities, including hypertension, diabetes mellitus, obesity, and sleep apnoea. During 1-year follow-up, 435 deaths (6.8%) and 89 thromboembolic events (1.4%) occurred. Patient-reported outcomes showed that 55% of patients had indicators of reduced quality of life. Conclusion Assessment of quality indicators revealed the gaps in AF care among Chinese patients, highlighting the need for a more integrated or holistic approach to AF management.</p

    Impact of quality of anticoagulation control on outcomes in patients with atrial fibrillation taking aspirin: An analysis from the SPORTIF trials

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    BACKGROUND: Concomitant aspirin (ASA) is often prescribed in anticoagulated patients with atrial fibrillation (AF). We aimed to investigate the relationship between ASA use and quality of anticoagulation control determining major adverse outcomes.METHODS: An ancillary analysis of patients in the warfarin arm of the SPORTIF III and V trials was performed. Quality of anticoagulation control was defined using time in therapeutic range (TTR).RESULTS: 3624 AF patients on warfarin were available for analysis: 1712 (47.2%) were ASA non-users with good anticoagulation control (TTR≥65%) [Group I], 380 (10.5%) were ASA users with TTR≥65% [Group II], 1192 (32.9%) were ASA non-users with TTR&lt;65% [Group III] and 340 (9.4%) were ASA users with TTR&lt;65% [Group IV]. CHA2DS2-VASc was similar across the groups (p=0.350), conversely HAS-BLED was progressively higher (p&lt;0.001). At follow-up, stroke/systemic embolism rates were similar across the groups (p=0.162). Conversely, a progressively higher rate for major bleeding was found (p=0.034), as well as higher rates for all-cause death in Group III and IV (p&lt;0.001). Kaplan-Meier analyses found a progressively higher risk for major bleeding across the groups (p=0.005) and a higher all-cause death risk in Group III and IV (p&lt;0.001). Cox regression analysis confirmed that Group III and IV were at higher risk for major bleeding (p=0.005) and all-cause death (p=0.010).CONCLUSIONS: Poor anticoagulation control is associated with higher bleeding risk, which is even greater with concomitant ASA use, with no difference in stroke/SE risk. Poor anticoagulation control is associated with a higher risk for all-cause death, independent of concomitant ASA use.</p

    Modelling projections for the uptake of edoxaban in an European population to 2050:effects on stroke, thromboembolism, and health economics perspectives

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    AIMS: In the coming decades, the number of Europeans with atrial fibrillation (AF) is set to rise as the population ages, and so with it will the number of strokes. The risk of thromboembolism (principally stroke and systemic embolism) and death can be reduced by the use of the vitamin K antagonists (VKA, e.g. warfarin) and more so by non-VKA oral anticoagulants (NOACs) such as edoxaban.METHODS AND RESULTS: We modelled the effect of the increasing use of edoxaban in preference to warfarin in a European AF population from both clinical and economic perspectives. We estimate that the introduction of NOACs in 2010 eliminated over 88 000 thromboembolisms and deaths annually, of which over 17 000 were ischaemic strokes. At a 1-year cost of €30k per ischaemic stroke, this strategy saved €510 million annually. Should the use of edoxaban increase from 11% in 2013 to 75% by 2030, we expect that rate of thromboembolism and death will fall from 5.67 to 5.42 total events per million patients per year, which will further eliminate over 12 000 of these events annually. At an inflation-adjusted 1-year cost of approximately €35k per ischaemic stroke, this will save €44.5 million each year. At a conservative rate of increase in the AF population of 2.2-fold from 2005, in 2050 there will be around 180 000 AF-related ischaemic strokes that, at an inflation-adjusted cost of around €62k per stroke, sums to €11 116 million. Should the rate of AF rise 2.6-fold from 2005, then in 2050 there will be 214 500 ischaemic strokes that will cost around €13 300 million.CONCLUSION: Our data point to a substantial increase in the human and economic cost burden of AF and so emphasize the need to reduce this burden. This may be achieved by the increased use of oral anticoagulants, particularly with the NOACs such as edoxaban.</p

    Simple decision-making between a vitamin K antagonist and a non-vitamin K antagonist oral anticoagulant: using the SAMe-TT2R2score

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    Stroke prevention with oral anticoagulation (OAC) is central to the modern management of atrial fibrillation (AF) patients.1 For many years, vitamin K antagonists (VKAs, e.g. warfarin) have been the default class of OAC, but we now recognize that it is not simply prescribing VKA but very close attention to quality of anticoagulation control is necessary, as reflected by the individual time in therapeutic range (TTR).2 An average individual TTR of >70% is recommended to maximize efficacy and safety of the VKAs.2,3 Nonetheless, the VKAs have significant inter- and intra-patient variability, partly from diet and drug interactions, thus necessitating regular international normalised ratio (INR) monitoring.2 More recently, we have had the non-VKA oral anticoagulants (NOACs, previously referred to as new or novel OACs4) available, which offer efficacy, safety, and relative convenience compared with the VKAs, for stroke prevention in AF
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