Risks and benefits of combining aspirin with anticoagulant therapy in patients with atrial fibrillation: an exploratory analysis of stroke prevention using an oral thrombin inhibitor in atrial fibrillation (SPORTIF) trials. Factors affecting bleeding risk during anticoagulant therapy in patients with atrial fibrillation: observations from the Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) study. Dual antiplatelet therapy versus oral anticoagulation plus dual antiplatelet therapy in patients with atrial fibrillation and low-to-moderate thromboembolic risk undergoing coronary stenting: design of the MUSICA-2 randomized trial. Prevalence of atrial fibrillation and eligibility for anticoagulants in the community Anemia is associated with bleeding and mortality, but not stroke, in patients with atrial fibrillation: Insights from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial Relation of Nonvalvular Atrial Fibrillation to Body Mass Index (from the SPORTIF Trials). Patient knowledge and perceptions of atrial fibrillation and anticoagulant therapy: effects of an educational intervention programme. The West Birmingham Atrial Fibrillation Project. Apixaban versus Antiplatelet drugs or no antithrombotic drugs after anticoagulation-associated intraCerebral HaEmorrhage in patients with Atrial Fibrillation (APACHE-AF): study protocol for a randomised controlled trial [Study of combined anticoagulant (fluindione)-aspirin therapy in patients with atrial fibrillation at high risk for thromboembolic complications. A randomized trial (FFAACS)]. Dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation: NICE guidance Focused 2012 update of the Canadian Cardiovascular Society atrial fibrillation guidelines: recommendations for stroke prevention and rate/rhythm control. Does left atrial appendage closure with a cardiac plug system reduce the stroke risk in nonvalvular atrial fibrillation patients? A single-center case series. The ORBIT bleeding score: a simple bedside score to assess bleeding risk in atrial fibrillation Bleeding risk during oral anticoagulation in atrial fibrillation patients older than 80 years. Higher risk of death and stroke in patients with persistent vs. paroxysmal atrial fibrillation: results from the ROCKET-AF Trial Anemia predicts thromboembolic events, bleeding complications and mortality in patients with atrial fibrillation: insights from the RE-LY trial. Efficacy and safety of percutaneous left atrial appendage closure to prevent thromboembolic events in atrial fibrillation patients with high stroke and bleeding risk Rationale and design of the Apixaban for the Reduction of Thrombo‐Embolism in Patients With Device‐Detected Sub‐Clinical Atrial Fibrillation (ARTESiA) trial Warfarin versus aspirin for stroke prevention in an elderly community population with atrial fibrillation (the Birmingham Atrial Fibrillation Treatment of the Aged Study, BAFTA): a randomised controlled trial Stroke due to atrial fibrillation in a population-based stroke registry (Ludwigshafen Stroke Study) CHADS(2) , CHA(2) DS(2) -VASc score, underuse of oral anticoagulation, and implications for preventive measures. Anticoagulation in women with non-valvular atrial fibrillation in the stroke prevention using an oral thrombin inhibitor (SPORTIF) trials. Multicenter randomized study of anticoagulation guided by remote rhythm monitoring in patients with implantable cardioverter-defibrillator and CRT-D devices: Rationale, design, and clinical characteristics of the initially enrolled cohort The IMPACT study. Prevalence, clinical profile, and cardiovascular outcomes of atrial fibrillation patients with atherothrombosis.
BACKGROUND Aspirin is used in combination with anticoagulant therapy in patients with atrial fibrillation ( AF ) , but evidence of additional efficacy is not available . METHODS We compared ischemic events and bleeding in the SPORTIF III and IV r and omized trials of anticoagulation with warfarin ( international normalized ratio 2 - 3 ) or fixed-dose ximelagatran . Low-dose aspirin ( < 100 mg/d ) was allowed based on prevailing guidelines . RESULTS The 14 % of patients receiving aspirin more often had diabetes ( 27.5 % vs 23 % , P < .01 ) , coronary artery disease ( 69 % vs 41 % , P < .01 ) , previous stroke or transient ischemic attack ( 26 % vs 20 % , P < .01 ) , and left ventricular dysfunction ( 41 % vs 36 % , P < .01 ) . Addition of aspirin to either warfarin or ximelagatran was associated with no reduction in stroke or systemic embolism . Major bleeding occurred significantly more often with aspirin plus warfarin ( 3.9 % per year ) than with warfarin alone ( 2.3 % per year , P < .01 ) , aspirin plus ximelagatran ( 2.0 % per year ) , or ximelagatran alone ( 1.9 % per year ) . The rate of myocardial infa rct ion with aspirin and warfarin ( 0.6 % per year ) was not significantly different from that with ximelagatran alone ( 1.0 % per year ) , warfarin alone ( 1.0 % per year ) , or aspirin and ximelagatran ( 1.4 % per year ) . CONCLUSIONS Aspirin combined with anticoagulant therapy was associated with no reduction in stroke , systemic embolism , or myocardial infa rct ion in patients with AF . Aspirin combined with warfarin was associated with an incremental rate of major bleeding of 1.6 % per year . No increased major bleeding occurred with aspirin and ximelagatran . These results suggest that the risks associated with addition of aspirin to anticoagulation in patients with AF outweigh the benefit BACKGROUND Stroke and systemic thromboembolism are serious problems for patients with atrial fibrillation ( AF ) , but their incidence can be substantially reduced by appropriate anticoagulation . Bleeding is the major complication of anticoagulant treatment , and the relative risks for bleeding vs stroke must be considered when starting anticoagulation . METHODS The AFFIRM trial included patients with AF and at least one risk factor for stroke , r and omly assigning them to either a rate-control or rhythm-control strategy . All patients were initially treated with warfarin . The incidence of protocol -defined major and minor bleeding was documented during follow-up . Variables associated with bleeding were determined using a Cox proportional hazards model , using baseline and time-dependent covariates . RESULTS The 4060 patients in the AFFIRM trial were followed for an average of 3.5 years . Major bleeding occurred in 260 patients , an annual incidence of approximately 2 % per year , with no significant difference between the rate-control and rhythm-control groups . Increased age , heart failure , hepatic or renal disease , diabetes , first AF episode , warfarin use , and aspirin use were significantly associated with major bleeding . Minor bleeding was common in both treatment arms , with 738 patients reporting this problem in one or more visits . CONCLUSIONS Bleeding is a significant problem that complicates management of patients with AF . Risk factors for bleeding can be identified , and knowledge of these risk factors can be used to plan therapy BACKGROUND Oral anticoagulation ( OAC ) is the recommended therapy for patients with atrial fibrillation ( AF ) because it reduces the risk of stroke and other thromboembolic events . Dual antiplatelet therapy ( DAPT ) is required after percutaneous coronary intervention and stenting ( PCI-S ) . In patients with AF requiring PCI-S  , the association of DAPT and OAC carries an increased risk of bleeding , whereas OAC therapy or DAPT alone may not protect against the risk of developing new ischemic or thromboembolic events . OBJECTIVE The MUSICA-2 study will test the hypothesis that DAPT compared with triple therapy ( TT ) in patients with nonvalvular AF at low-to-moderate risk of stroke ( CHADS2 score ≤2 ) after PCI-S reduces the risk of bleeding and is not inferior to TT for preventing thromboembolic complications . DESIGN The MUSICA-2 is a multicenter , open-label r and omized trial that will compare TT with DAPT in patients with AF and CHADS2 score ≤2 undergoing PCI-S.  The primary end point is the incidence of stroke or any systemic embolism or major adverse cardiac events : death , myocardial infa rct ion , stent thrombosis , or target vessel revascularization at 1 year of PCI-S. The secondary end point is the combination of any cardiovascular event with major or minor bleeding at 1 year of PCI-S. The calculated sample size is 304 patients . CONCLUSIONS The MUSICA-2 will attempt to determine the most effective and safe treatment in patients with nonvalvular AF and CHADS2 score ≤2 after PCI-S. Restricting TT for AF patients at high risk for stroke may reduce the incidence of bleeding without increasing the risk of thromboembolic complications BACKGROUND Anticoagulants are effective in the prevention of stroke in atrial fibrillation and flutter ( AF ) . We aim ed to find out the prevalence of AF in the UK and to estimate the proportion of patients with AF who might benefit from anticoagulation . METHODS We screened with electrocardiography a r and om sample of 4843 people from the community aged 65 years and older for AF . Participants with AF had further investigations to identify risk factors for stroke and contraindications to anticoagulants . We used three sets of criteria to assess risk and eligibility for anticoagulation . FINDINGS 228 ( 4.7 % ) participants had AF . According to analyses derived from risk stratifications based on the Stroke Prevention in Atrial Fibrillation ( SPAF ) study 61 % of these patients would have benefited from anticoagulation , 49 % according to pooled analysis of trial results , and 41 % according to the inclusion criteria for the SPAF 3 study .  Anticoagulants  were used by 1114 ( 23 % ) of all patients and were least used among elderly women , who may be the most likely to benefit . Echocardiography would be useful to assess the need for anticoagulation only in patients younger than 75 years with no contraindications to treatment and no clinical risk factors for stroke . INTERPRETATION Anticoagulants seem to be underused and misdirected in treatment of AF , according to various criteria . Efforts to promote and support wider and more appropriate use of anticoagulants would seem to be justified , and should decrease the incidence of stroke amongst elderly patients Background Patients with atrial fibrillation ( AF ) are prone to cardiovascular events and anticoagulation‐related bleeding complications . We hypothesized that patients with anemia are at increased risk for these outcomes . Methods We performed a post hoc analysis of the ARISTOTLE trial , which included > 18,000 patients with AF r and omized to warfarin ( target international normalized ratio , 2.0‐3.0 ) or apixaban 5 mg twice daily .  Multivariable Cox regression analysis was used to determine if anemia ( defined as hemoglobin < 13.0 in men and < 12.0 g/dL in women ) was associated with future stroke , major bleeding , or mortality . Results Anemia was present at baseline in 12.6 % of the ARISTOTLE population . Patients with anemia were older , had higher mean CHADS2 and HAS‐BLED scores , and were more likely to have experienced previous bleeding events . Anemia was associated with major bleeding ( adjusted hazard ratio [ HR ] , 1.92 ; 95 % CI , 1.62‐2.28 ; P < .0001 ) and all‐cause mortality ( adjusted HR , 1.68 ; 95 % CI , 1.46‐1.93 ; P < .0001 ) but not stroke or systemic embolism ( adjusted HR , 0.92 ; 95 % CI , 0.70‐1.21 ) . The benefits of apixaban compared with warfarin  on the rates of stroke , mortality , and bleeding events were consistent in patients with and without anemia . Conclusions Chronic anemia is associated with a higher incidence of bleeding complications and mortality , but not of stroke , in anticoagulated patients with AF .  Apixaban is an attractive anticoagulant for stroke prevention in patients with AF with or without anemia Obesity is well-established as a major cardiovascular ( CV ) risk factor . Obesity confers a greater risk for developing atrial fibrillation ( AF ) , but the relation between obesity and established nonvalvular AF for stroke and all-cause death is still unclear . To ascertain the prevalence of overweight and obesity in patients with nonvalvular AF , their influence on adverse events , and the relation with anticoagulation control , we performed this post hoc analysis of the pooled Stroke Prevention using an Oral Thrombin Inhibitor in patients with atrial Fibrillation ( SPORTIF ) III and V data sets . For this study , we analyzed all patients assigned to the warfarin arm with data on body mass index ( BMI ) . Time in therapeutic range was used as an index of the quality of anticoagulation control . The 3,630 patients eligible for this analysis were categorized as follows : ( 1 ) BMI 18.5 to 24.9 ( " normal weight " ) in 24.1 % ; ( 2 ) BMI 25.0 to 29.9 ( " overweight " ) in 39.8 % ; and BMI ≥30 ( " obese " ) in 36.1 % . Both overweight ( hazard ratio [ HR ] 0.70 ) and obese ( HR 0.59 ) categories were inversely associated with the composite outcome of stroke/all-cause death . A similar inverse association was seen for the end point of stroke ( HR 0.61 and 0.47 , respectively ) . Good anticoagulation control also attenuated the association between BMI categories and outcomes . In patients with time in therapeutic range > 70 % , BMI category was not significantly associated with the composite outcome of stroke/death and stroke . Stroke and all-cause death progressively reduced in overweight and obese anticoagulated patients with AF . The inverse relation of BMI categories to the risk of stroke and all-cause death was mitigated by good anticoagulation control OBJECTIVE Previous research has demonstrated that patients with atrial fibrillation ( AF ) possess very little knowledge of their disease , the consequences of AF and the benefits /risks of anti-coagulant therapy . The aim of this pilot study was to examine patient 's knowledge and perceptions of AF and their anticoagulant treatment before and after a brief educational intervention . MATERIAL S AND METHODS Ninety-three patients ( 47 male ; mean ( S.D. ) age 67.3 ( 11.6 ) years ) completed the baseline interview to assess their knowledge and perceptions of AF . All patients were given an information booklet which explained what AF was , associated symptoms , the possible causes and consequences of AF , treatment options and their benefits /risks , what the INR is and what factors may effect it . The booklet was explained to each patient by the research er and given to the patient to take away for reference . Thirty-three ( 35.5 % ) patients ( 12 men ; mean ( S.D. ) age 68.0 ( 13.6 ) years ) completed the follow-up assessment to re-assess their knowledge and perceptions of AF . RESULTS Only 49 % of patients could name their cardiac condition at baseline , although the majority were aware that AF was an arrhythmia ( 80 % baseline vs. 91 % follow-up ) . Only about half the patients perceived AF as a serious condition or were aware that AF predisposes to thromboembolism at baseline . Following the educational intervention there was a non-significant increase in patient knowledge of the risks associated with AF . Of those who completed both question naires , 52 % were aware that anticoagulants prevented blood clots , which increased to 70 % post-intervention . However , few patients were aware of the benefit of stroke prevention associated with anticoagulants at baseline ( 21 % ) or after the educational intervention ( 27 % ) . The intervention had little effect on increasing awareness of the bleeding risks associated with anticoagulants , although three in five people appeared to appreciate these risks . However , the educational intervention significantly improved patient 's knowledge of the target INR range and factors that may affect INR levels ( p=0.001 and p=0.014 , respectively ) for those who completed both question naires . CONCLUSIONS Most patients with AF possess very limited knowledge about their cardiac condition , its consequences , and how anticoagulant treatment can benefit them . This pilot study has demonstrated that a brief educational intervention with an information booklet can help to somewhat improve their knowledge about anticoagulation therapy for AF Background There is a marked lack of evidence on the optimal prevention of ischaemic stroke and other thromboembolic events in patients with non-valvular atrial fibrillation and a recent intracerebral haemorrhage during treatment with oral anticoagulation .  These patients are currently treated with oral anticoagulants , antiplatelet drugs , or no antithrombotic treatment , depending on personal and institutional preferences . Compared with warfarin , the direct oral anticoagulant apixaban reduces the risk of stroke or systemic embolism , intracranial haemorrhage , and case fatality in patients with atrial fibrillation . Compared with aspirin , apixaban reduces the risk of stroke or systemic embolism in patients with atrial fibrillation , and has a similar risk of intracerebral haemorrhage . Novel oral anticoagulants have not been evaluated in patients with atrial fibrillation and a recent intracerebral haemorrhage . To inform a phase III trial , the phase II Apixaban versus Antiplatelet drugs or no antithrombotic drugs after anticoagulation-associated intraCerebral HaEmorrhage in patients with Atrial Fibrillation ( APACHE-AF ) trial aims to obtain estimates of the rates of vascular death or non-fatal stroke in patients with atrial fibrillation and a recent anticoagulation-associated intracerebral haemorrhage treated with apixaban and in those in whom oral anticoagulation is avoided . Methods / Design APACHE-AF is a phase II , multicentre , open-label , parallel-group , r and omised clinical trial with masked outcome assessment . One hundred adults with a history of atrial fibrillation and a recent intracerebral haemorrhage during treatment with anticoagulation in whom clinical equipoise exists on the optimal stroke prevention strategy will be enrolled in 14 hospitals in The Netherl and s . These patients will be r and omly assigned in a 1:1 ratio to either apixaban or to avoiding oral anticoagulation . Patients in the control group may be treated with antiplatelet drugs at the discretion of the treating physician . The primary outcome is the composite of vascular death or non-fatal stroke during follow-up . We aim to include 100 patients in 2.5 years . All patients will be followed-up for the duration of the study , but at least for 1 year . Recruitment commenced in September 2014 and is ongoing . This trial is funded by the Dutch Heart Foundation ( 2012 T077 ) and ZonMW (015008048).Trial registration NTR4526 ( 16 April 2014 ) BACKGROUND A combination of low-dose aspirin ( A ) and anticoagulation ( AC ) may provide better protection against thromboembolic events compared with AC alone in high-risk patients with atrial fibrillation ( AF ) . METHODS We performed a multicentric placebo-controlled double blind-trial to test the preventive efficacy against thromboembolic events of the addition of aspirin ( A ) ( 100 mg ) or placebo ( P ) to anticoagulant treatment in patients with high-risk atrial fibrillation . A total of 157 patients were included , with atrial fibrillation and previous thromboembolic event or older than 65 years with either a history of hypertension , a recent episode of heart failure or a left ventricular dysfunction . All patients received fluindione ( F ) and P or F and A , with an INR target between 2 and 2.6 . The primary endpoint was a combined endpoint of stroke ( ischaemic or haemorrhagic ) , myocardial infa rct ion , systemic arterial emboli or vascular death . RESULTS The study had to be stopped prematurely owing to a too low recruitment rate . During follow-up ( 0.84 years ) 3 non-fatal thromboembolic events were recorded ( 1P , 2A ) and 6 patients died ( 3P , 3A ) , none of them from a thromboembolic complication . However , 3 deaths were secondary to severe haemorrhagic complications ( 1P , 2A ) . Non-fatal haemorrhagic complications occurred more often in group A ( n = 10 , 13.1 pour cent ) compared with group P ( n = 1 , 1.2 pour cent ) , p = 0.003 . CONCLUSION The FFAACS study was not able to show any therapeutic benefit from the addition of aspirin to anticoagulant in patients with high-risk AF . Such a combination increased the incidence rate of bleeding complications , which therefore greatly reduces its potential overall benefit Atrial fibrillation ( AF ) is the commonest sustained cardiac arrhythmia , whose importance has been realised given its strong association with stroke and systemic embolism that can be significantly reduced by oral anticoagulation . Until recently , the only oral anticoagulant ( OAC ) available was the vitamin K antagonist ( VKA ) class of drugs — for example , warfarin . Indeed , warfarin provides highly effective prophylaxis against thromboembolism as shown by extensive evidence from r and omised controlled trials , but its effectiveness is dependent upon good anticoagulation control ( as reflected by its high length of time in the therapeutic range).1 The risk of stroke in AF is not homogeneous , and depends upon the presence or absence of several risk factors . These risk factors have been used to formulate stroke risk stratification schemes , so that the focus has been to identify ‘ high-risk ’ patients who could be targeted for this ‘ inconvenient ’ drug , warfarin . The numerous practical limitations which affect a clinician 's willingness to prescribe warfarin , and a patient 's willingness to comply with it ( box 1 ) , have result ed in large numbers of high-risk patients either unprotected against stroke or suboptimally protected with antiplatelet therapy2—despite evidence that aspirin is less effective for stroke prevention and is not without its own bleeding risk , especially in the elderly.3 Box 1 # # # Limitations of warfarin The limitations of warfarin have driven efforts to establish new OACs which can circumvent the shortcomings of the VKAs . The new OACs fall into two classes : the oral direct thrombin inhibitors ( eg , dabigatran ) and the oral factor Xa inhibitors ( eg . rivaroxaban , apixaban).4 The National Institute for Health The Canadian Cardiovascular Society ( CCS ) published the complete set of 2010 Atrial Fibrillation ( AF ) Guidelines in the January , 2011 issue of the Canadian Journal of Cardiology . During its deliberations , the CCS Guidelines Committee engaged to a timely review of future evidence , with periodic composition of focused up date s to address clinical ly important advances . In 2011 , results were published from 3 pivotal AF trials : the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonist for Prevention of Stroke and Embolism Trial in Atrial Fibrillation ( ROCKET-AF ) , the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation ( ARISTOTLE ) study , and the Permanent Atrial Fibrillation Outcome Study Using Dronedarone on Top of St and ard Therapy ( PALLAS ) , comparing dronedarone with placebo in patients with permanent AF and additional cardiovascular disease risk-factor burden . Each of these large r and omized trials provided clear results with major implication s for AF management . Other important evidence that has emerged since the 2010 Guidelines includes findings about prediction instruments for AF-associated stroke and bleeding risk , stroke risk in paroxysmal-AF patients , risk-benefit considerations related to oral anticoagulation in patients with chronic kidney disease , and risk/benefit considerations in the use of antiplatelet agents , alone and in combination with each other or with oral anticoagulants , in AF patients . The Guidelines Committee judged that this extensive and important new evidence required focused updating of the 2010 Guidelines with respect to stroke prevention and rate/rhythm control . This report presents the details of the new recommendations , along with the background and rationale BACKGROUND Atrial fibrillation ( AF ) is the most common sustained cardiac arrhythmia and it is associated with an increased stroke risk , due mainly to cardiac embolism from the left atrial appendage ( LAA ) . Percutaneous LAA closure is a method to reduce stroke risk in AF without using anticoagulant agents . In this study we report data from an Italian experience with the LAA occluder Amplatzer Cardiac Plug ( ACP ) device ( Aga Medical Corporation , Plymouth , MN , USA ) . METHODS The study was design ed to evaluate the safety of LAA closure using ACP and the efficacy of the procedure in preventing strokes during a 1-year follow-up . Patients with permanent or paroxysmal AF , high stroke risk , and contraindication to warfarin therapy were selected for the procedure . RESULTS The LAA closure was attempted in 37 patients and succeeded in 34 cases ( 91.9 % ) . Four patients experienced serious complications ( one cardiac tamponade requiring pericardiocentesis , two device embolizations , one low-rate response AF requiring artificial pacing ) . During a 1-year follow-up , ischemic stroke occurred in one of 34 patients , result ing in a stroke rate of 2.94 % ; thus there was a stroke rate reduction of 50.2 % and 26.5 % compared to the expected stroke rate , according to CHADS2 and CHA2 DS2 VASc score . None of the patients who received ACP experienced major bleeding during the follow-up . CONCLUSION LAA closure using ACP is a relatively feasible procedure which can be performed by highly experienced operators to reduce stroke rate in patients with AF , high stroke risk , and contraindication to oral anticoagulants Background Therapeutic decisions in atrial fibrillation ( AF ) are often influenced by assessment of bleeding risk . However , existing bleeding risk scores have limitations . Objectives We sought to develop and vali date a novel bleeding risk score using routinely available clinical information to predict major bleeding in a large , community-based AF population . Methods We analysed data from Outcomes Registry for Better Informed Treatment of Atrial Fibrillation ( ORBIT-AF ) , a prospect i ve registry that enrolled incident and prevalent AF patients at 176 US sites . Using Cox proportional hazards regression , we identified factors independently associated with major bleeding among patients taking oral anticoagulation ( OAC ) over a median follow-up of 2 years ( interquartile range = 1.6–2.5 ) . We also created a numerical bedside risk score that included the five most predictive risk factors weighted according to their strength of association with major bleeding . The predictive performance of the full model , the simple five-item score , and two existing risk scores ( hypertension , abnormal renal/liver function , stroke , bleeding history or predisposition , labile INR , elderly , drugs/alcohol concomitantly , HAS-BLED , and anticoagulation and risk factors in atrial fibrillation , ATRIA ) were then assessed in both the ORBIT-AF cohort and a separate clinical trial population , Rivaroxaban Once-daily oral direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation ( ROCKET-AF ) . Results Among 7411 ORBIT-AF patients taking OAC , the rate of major bleeding was 4.0/100 person-years . The full continuous model ( 12 variables ) and five-factor ORBIT risk score ( older age [ 75 + years ] , reduced haemoglobin/haematocrit/history of anaemia , bleeding history , insufficient kidney function , and treatment with antiplatelet ) both had good ability to identify those who bled vs. not ( C-index 0.69 and 0.67 , respectively ) . These scores both had similar discrimination , but markedly better calibration when compared with the HAS-BLED and ATRIA scores in an external validation population from the ROCKET-AF trial . Conclusions The five-element ORBIT bleeding risk score had better ability to predict major bleeding in AF patients when compared with HAS-BLED and ATRIA risk scores . The ORBIT risk score can provide a simple , easily remembered tool to support clinical decision making OBJECTIVES We sought to evaluate the rate of bleeding in relation to age ( < 80 and > or = 80 years ) , the quality of anticoagulation ( expressed as time spent in international normalized ratio therapeutic range ) , and factors associated with bleeding events . BACKGROUND Stroke prevention in patients with atrial fibrillation ( AF ) is an increasingly crucial public health target , particularly in patients ages > or = 80 years . METHODS We conducted a prospect i ve observational study on 783 patients with AF on oral anticoagulant treatment ( OAT ) .  RESULTS Patients spent a median 14 % , 71 % , and 15 % of time below , within , and above the intended therapeutic range , respectively . No difference in OAT quality was found between patients age < 80 and > or = 80 years . During follow-up , 94 patients experienced bleeding complications ( rate 3.7 x 100 patient/years ) , 37 major ( rate 1.4 x 100 patient/years ) , and 57 minor ( rate 2.2 x 100 patient/years ) . Different rates of major hemorrhage were observed between patients age < 80 and > or = 80 years ( 0.9 vs. 1.9 x 100 patient/years ; p = 0.004 ) . Bleeding risk also was greater in patients with a history of previous cerebral ischemic event ( odds ratio [ OR ] : 2.5 ; 95 % confidence interval : 1.3 to 4.8 ; p = 0.007 ) . A Cox regression analysis confirmed age > or = 80 years associated with bleeding risk ( OR : 2.0 ) . CONCLUSIONS These results indicate that the rate of major bleeding complications may be kept acceptably low also in very elderly AF patients on OAT , provided a careful management of anticoagulation is obtained Aim Anticoagulation prophylaxis for stroke is recommended for at-risk patients with either persistent or paroxysmal atrial fibrillation ( AF ) . We compared outcomes in patients with persistent vs. paroxysmal AF receiving oral anticoagulation . Methods and results Patients r and omized in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation ( ROCKET-AF ) trial ( n = 14 264 ) were grouped by baseline AF category : paroxysmal or persistent . Multivariable adjustment was performed to compare thrombo-embolic events , bleeding , and death between groups , in high-risk subgroups , and across treatment assignment ( rivaroxaban or warfarin ) . Of 14 062 patients , 11 548 ( 82 % ) had persistent AF and 2514 ( 18 % ) had paroxysmal AF . Patients with persistent AF were marginally older ( 73 vs. 72 , P = 0.03 ) , less likely female ( 39 vs. 45 % , P < 0.0001 ) , and more likely to have previously used vitamin K antagonists ( 64 vs. 56 % , P < 0.0001 ) compared with patients with paroxysmal AF . In patients r and omized to warfarin , time in therapeutic range was similar ( 58 vs. 57 % , P = 0.94 ) . Patients with persistent AF had higher adjusted rates of stroke or systemic embolism ( 2.18 vs. 1.73 events per 100-patient-years , P = 0.048 ) and all-cause mortality ( 4.78 vs. 3.52 , P = 0.006 ) . Rates of major bleeding were similar ( 3.55 vs. 3.31 , P = 0.77 ) . Rates of stroke or systemic embolism in both types of AF did not differ by treatment assignment ( rivaroxaban vs. warfarin , Pinteraction = 0.6 ) . Conclusion In patients with AF at moderate-to-high risk of stroke receiving anticoagulation , those with persistent AF have a higher risk of thrombo-embolic events and worse survival compared with paroxysmal AF BACKGROUND Anemia may predispose to thromboembolic events or bleeding in anticoagulated patients with atrial fibrillation ( AF ) . OBJECTIVES To investigate whether anemia is associated with thromboembolic events and bleeding in patients with AF . PATIENTS AND METHODS We retrospectively analyzed the RE-LY trial data base , which r and omized 18 113 patients with AF and a risk of stroke to receive dabigatran or warfarin for a median follow-up of 2 years .  Cox regression analysis was used to determine whether anemia predicted cardiovascular events and bleeding complications in these patients . RESULTS Anemia was present in 12 % of the population at baseline , and the presence of anemia was associated with a higher risk of thromboembolic cardiovascular events , including the composite endpoint of all-cause mortality or myocardial infa rct ion ( adjusted hazard ratio [ HR ] 1.50 , 95 % confidence interval [ CI ] 1.32 - 1.71 ) and the primary RE-LY outcome of stroke or systemic embolism ( adjusted HR 1.41 , 95 % CI 1.12 - 1.78 ) . Anemia was also associated with a higher risk of major bleeding complications ( adjusted HR 2.14 , 95 % CI 1.87 - 2.46 ) and discontinuation of anticoagulants ( adjusted HR 1.40 , 95 % CI 1.28 - 1.79 ) . The association between anemia and outcome was similar irrespective of cardiovascular comorbidities , r and omized treatment allocation , or prior use of warfarin . The incidence of events was lower in patients with transient anemia than in patients in whom anemia was sustained ( adjusted HR 0.66 , 95 % CI 0.49 - 0.91 ) . CONCLUSIONS Anemia is associated with an increased risk of thromboembolic events , bleeding complications and mortality in anticoagulated patients with AF . These findings suggest that patients with anemia should be monitored closely during all types of anticoagulant treatment Aims The r and omized PROTECT AF trial demonstrated non-inferiority of left atrial appendage ( LAA ) closure to oral anticoagulation with warfarin . Current guidelines give a class IIb recommendation for LAA closure . We evaluated the efficacy and safety of LAA closure in a consecutive series of non-valvular atrial fibrillation patients with contraindications to long-term oral anticoagulation or at high bleeding risk . Methods and results 101 consecutive non-valvular atrial fibrillation patients ( age 74.7 ± 7.5 years ) at high risk for stroke ( CHA2DS2-VASc Score 4.4 ± 1.6 ) and high bleeding risk ( HAS-BLED Score 4.2 ± 1.3 ) received LAA closure with either the Watchman closure device ( n = 38 ) or the Amplatzer cardiac plug ( n = 63 ) . Dual antiplatelet therapy with aspirin and clopidogrel was recommended for 3–6 months after device implantation , followed by long-term antiplatelet therapy with aspirin . No anticoagulation was given after device implantation . Mean follow-up was 400 days . One patient ( 1 % ) experienced a transient ischemic attack , and two patients ( 2 % ) suffered from ischemic stroke . While on recommended antiplatelet therapy , bleeding occurred in 12/101 patients ( 12 % ) . Bleeding was significantly reduced with 3 compared with 6 months dual antiplatelet therapy ( 3.0 vs. 16.2 % , p < 0.05 ) while ischemic or thrombotic events were similar . Conclusion Left atrial appendage closure in patients with non-valvular atrial fibrillation and high risk for stroke and bleeding events effectively prevented stroke and reduced cerebral ischemic events compared to expected stroke rate according to CHA2DS2-VASc Score . Dual antiplatelet therapy for 3 months reduced the rate of bleeding events compared to 6 months therapy with no increase of thrombotic events Background Device‐detected sub clinical atrial fibrillation ( AF ) refers to infrequent , short‐lasting , asymptomatic AF that is detected only with long‐term continuous monitoring . Sub clinical AF is common and associated with an increased risk of stroke ; however , the risk of stroke with sub clinical AF is lower than for clinical AF , and very few patients with sub clinical AF alone have been included in large AF anticoagulation trials . The net benefit of anticoagulation in patients with sub clinical AF is unknown . Design ARTESiA is a prospect i ve , multicenter , double‐blind , r and omized controlled trial , recruiting patients with sub clinical AF detected by an implanted pacemaker , defibrillator , or cardiac monitor , and who have additional risk factors for stroke . Patients with clinical AF documented by surface electrocardiogram will be excluded from the study . Participants will be r and omized to receive either apixaban ( according to st and ard AF dosing ) or aspirin 81 mg daily . The primary outcome is the composite of stroke , transient ischemic attack with diffusion‐weighted magnetic resonance imaging evidence of cerebral infa rct ion , and systemic embolism . Approximately 4,000 patients will be enrolled from around 230 clinical sites , with an anticipated mean follow‐up of 36 months until 248 adjudicated primary outcome events have occurred . Summary ARTESiA will determine whether oral anticoagulation therapy with apixaban compared with aspirin reduces the risk of stroke or systemic embolism in patients with sub clinical AF and additional risk factors BACKGROUND Anticoagulants are more effective than antiplatelet agents at reducing stroke risk in patients with atrial fibrillation , but whether this benefit outweighs the increased risk of bleeding in elderly patients is unknown . We assessed whether warfarin reduced risk of major stroke , arterial embolism , or other intracranial haemorrhage compared with aspirin in elderly patients . METHODS 973 patients aged 75 years or over ( mean age 81.5 years , SD 4.2 ) with atrial fibrillation were recruited from primary care and r and omly assigned to warfarin ( target international normalised ratio 2 - 3 ) or aspirin ( 75 mg per day ) . Follow-up was for a mean of 2.7 years ( SD 1.2 ) . The primary endpoint was fatal or disabling stroke ( ischaemic or haemorrhagic ) , intracranial haemorrhage , or clinical ly significant arterial embolism . Analysis was by intention to treat . This study is registered as an International St and ard R and omised Controlled Trial , number IS RCT N89345269 . FINDINGS There were 24 primary events ( 21 strokes , two other intracranial haemorrhages , and one systemic embolus ) in people assigned to warfarin and 48 primary events ( 44 strokes , one other intracranial haemorrhage , and three systemic emboli ) in people assigned to aspirin ( yearly risk 1.8%vs 3.8 % , relative risk 0.48 , 95 % CI 0.28 - 0.80 , p=0.003 ; absolute yearly risk reduction 2 % , 95 % CI 0.7 - 3.2 ) . Yearly risk of extracranial haemorrhage was 1.4 % ( warfarin ) versus 1.6 % ( aspirin ) ( relative risk 0.87 , 0.43 - 1.73 ; absolute risk reduction 0.2 % , -0.7 to 1.2 ) . INTERPRETATION These data support the use of anticoagulation therapy for people aged over 75 who have atrial fibrillation , unless there are contraindications or the patient decides that the benefits are not worth the inconvenience BACKGROUND AND PURPOSE Atrial fibrillation ( AF ) is amongst the most important etiologies of ischaemic stroke . In a population -based stroke registry , we tested the hypothesis of low adherence to current guidelines as a main cause of high rates of AF-associated stroke . METHODS Within the Ludwigshafen Stroke Study ( LuSSt ) , a prospect i ve ongoing population -based stroke register , we analyzed all patients with a first-ever ischaemic stroke ( FEIS ) owing to AF in 2006 and 2007 . We determined whether AF was diagnosed before stroke and assessed pre-stroke CHADS(2 ) and CHA(2 ) DS(2 ) -VASc scores . RESULTS In total , 187 of 626 patients with FEIS suffered from cardioembolic stroke owing to AF , which was newly diagnosed in 57 ( 31 % ) patients . Retrospective pre-stroke risk stratification according to CHADS(2 ) score indicated low/intermediate risk in 34 patients ( 18 % ) and high risk ( CHADS(2 ) ≥ 2 ) in 153 patients ( 82 % ) . Application of CHA(2 ) DS(2 ) -VASc score reduced number of patients at low/intermediate risk ( CHA(2 ) DS(2 ) -VASc score 0 - 1 ) to five patients ( 2.7 % ) . In patients with a CHADS(2 ) score ≥ 2 and known AF ( n = 106 ) before stroke , 38 ( 36 % ) were on treatment with vitamin K antagonists on admission whilst only in 16 patients ( 15 % ) treatment was in therapeutic range . CONCLUSIONS Our study strongly supports the hypothesis that underuse of oral anticoagulants in high-risk patients importantly contributes to AF-associated stroke . CHA(2 ) DS(2 ) -VASc score appears to be a more valuable risk stratification tool than CHADS(2 ) score . Preventive measures should focus on optimizing pre-stroke detection of AF and better implementation of present AF- guidelines with respect to anticoagulation therapy AIMS The risk of stroke is greater among women with atrial fibrillation ( AF ) than men .  Warfarin protects against stroke , but treatment-related bleeding occurs more often in women than in men . METHODS AND RESULTS SPORTIF III ( open label , n=3410 ) and V ( double-blind , n=3922 ) included 2257 women with AF and one or more stroke risk factors r and omized to warfarin [ target international normalized ratio ( INR ) 2.0 - 3.0 ] or ximelagatran ( 36 mg twice daily ) . Primary outcomes were all stroke ( ischaemic/haemorrhagic ) and systemic embolic event .  Women were older , on average , than men , 73.4+/-8.0 vs. 69.8+/-9.0 years ( P<0.0001 ) . More women were > 75-years old and women had more risk factors than men had ( P<0.0001 ) . The INR on warfarin ( mean 2.5+/-0.7 ) was within target range for 67 % of follow-up regardless of gender . Women more often developed primary events [ 2.08%/year , 95 % confidence interval ( CI ) 1.60 - 2.56%/year vs. 1.44%/year , 95 % CI 1.18 - 1.71%/year in men ; P=0.016 ) . Major bleeding rates were similar ( P=0.766 ) but women experienced more overall ( major/minor ) bleeding ( P<0.001 ) . Warfarin was associated with more overall bleeding in both genders and more major bleeding in women than in men ( P=0.001 ) . CONCLUSION When compared with men with AF , women in these studies were older and had more stroke risk factors . Women were more prone to anticoagulant-related bleeding ; the higher rate of thrombo-embolism among women was related to more frequent interruption of anticoagulant therapy Atrial fibrillation and atrial flutter are common cardiac arrhythmias associated with an increased risk of stroke in patients with additional risk factors .  Anticoagulation ameliorates stroke risk , but because these arrhythmias may occur intermittently without symptoms , initiation of prophylactic therapy is often delayed until electrocardiographic documentation is obtained . The IMPACT study is a multicenter , r and omized trial of remote surveillance technology in patients with implanted dual-chamber cardiac resynchronization therapy defibrillator ( CRT-D ) devices design ed to test the hypothesis that initiation and withdrawal of oral anticoagulant therapy guided by continuous ambulatory monitoring of the atrial electrogram improve clinical outcomes by reducing the combined rate of stroke , systemic embolism , and major bleeding compared with conventional clinical management . For those in the intervention group , early detection of atrial high-rate episodes ( AHRE ) generates an automatic alert to initiate anticoagulation based on patient-specific stroke risk stratification . Subsequently , freedom from AHRE for predefined periods prompts withdrawal of anticoagulation to avoid bleeding . Patients in the control arm are managed conventionally , the anticoagulation decision prompted by incidental detection of atrial fibrillation or atrial flutter during routine clinical follow-up . The results will help define the clinical utility of wireless remote cardiac rhythm surveillance and help establish the critical threshold of AHRE burden warranting anticoagulant therapy in patients at risk of stroke . In this report , we describe the study design and baseline demographic and clinical features of the initial cohort ( 227 patients ) BACKGROUND Atrial fibrillation ( AF ) is a major risk factor ( RF ) for ischemic stroke . Its prevalence and prognostic impact in patients with atherothrombosis are unclear . METHODS Risk factors , drug usage , and 1-year cardiovascular ( CV ) outcomes ( CV death , myocardial infa rct ion [ MI ] , and stroke ) were compared in  AF and non-AF patients from the REduction of Atherothrombosis for Continued Health ( REACH ) Registry , an international , prospect i ve cohort of 68,236 stable out patients with established atherothrombosis or > or=3 atherothrombotic RFs . RESULTS Atrial fibrillation and 1-year follow-up data are available for 63,589 patients . The prevalence of AF was , 12.5 % , 13.7 % , 11.5 % , and 6.2 % among coronary artery disease , CV disease , peripheral artery disease , and RF-only patients , respectively . Of the 6,814 patients with AF , 6.7 % experienced CV death , nonfatal MI , or nonfatal stroke within a year . The annual incidence of nonfatal stroke ( 2.4 % vs 1.6 % , P<.0001 ) and unstable angina ( 6.0 % vs 4.0 % , P<.00001 ) was higher , and CV death was more than double ( 3.2 % vs 1.4 % , P<.0001 ) , in AF versus non-AF patients . In these patients with or at high risk of atherothrombosis , most patients with AF received antiplatelet agents , but only 53.1 % were treated with oral anticoagulants . Even with high CHADS2 ( congestive heart failure , hypertension , aging , diabetes mellitus , and stroke ) scores , anticoagulant use did not exceed ( 59 % ) . The rate of bleeding requiring hospitalization was higher in AF versus non-AF patients ( 1.5 % vs 0.8 % , P<.0001 ) , possibly related to the more frequent use of anticoagulants ( 53.1 % vs 7.1 % ) . CONCLUSIONS Atrial fibrillation is common in patients with atherothrombosis , associated with more frequent fatal and nonfatal CV outcomes , and underuse of oral anticoagulants
Some of the risk factors for anticoagulation-related bleeding are also indications for the use of anticoagulants in AF patients .
Atrial fibrillation ( AF ) is associated with an increased stroke risk that may be reduced by therapeutic anticoagulation .
However , anticoagulation is associated with an increased risk of bleeding that in some patients may outweigh the benefits in reducing the risk of stroke .