Probing oral anticoagulation in patients with atrial high rate episodes: Rationale and design of the Non–vitamin K antagonist Oral anticoagulants in patients with Atrial High rate episodes (NOAH–AFNET 6) trial Adherence and Quality of Oral Anticoagulation in Cerebrovascular Disease Patients with Atrial Fibrillation Left Atrial Appendage Closure in Patients with Atrial Fibrillation and Previous Intracerebral Hemorrhage. Effectiveness and Safety of Non-Vitamin K Antagonist Oral Anticoagulants in Asian Patients With Atrial Fibrillation Early Clinical and Radiological Course, Management, and Outcome of Intracerebral Hemorrhage Related to New Oral Anticoagulants. Characteristics of Symptomatic Intracranial Hemorrhage in Patients Receiving Non-Vitamin K Antagonist Oral Anticoagulant Therapy Volume and functional outcome of intracerebral hemorrhage according to oral anticoagulant type Long-Term Outcome after Anticoagulation-Associated Intracerebral Haemorrhage with or without Restarting Antithrombotic Therapy Optimal oral anticoagulant therapy in patients with nonrheumatic atrial fibrillation and recent cerebral ischemia. Management and Prognostic Features of Intracerebral Hemorrhage During Anticoagulant Therapy: A Swedish Multicenter Study Lower versus standard intensity oral anticoagulant therapy (OAT) in elderly warfarin-experienced patients with non-valvular atrial fibrillation. Values and Preferences of Physicians and Patients With Nonvalvular Atrial Fibrillation Who Receive Oral Anticoagulation Therapy for Stroke Prevention. 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. 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 Comparative effects of antiplatelet, anticoagulant, or combined therapy in patients with valvular and nonvalvular atrial fibrillation: a randomized multicenter study. Novel oral anticoagulants in a real-world cohort of patients undergoing catheter ablation of atrial fibrillation. [Background and evaluation plan of a study on self-management of anticoagulation in patients with non-valvular atrial fibrillation (SMAAF Study)].
Background Oral anticoagulation prevents ischemic strokes in patients with atrial fibrillation ( AF ) . Early detection of AF and subsequent initiation of oral anticoagulation help to prevent strokes in AF patients . Implanted cardiac pacemakers and defibrillators allow seamless detection of atrial high rate episodes ( AHRE ) , but the best antithrombotic therapy in patients with AHRE is not known . Rationale Stroke risk is higher in pacemaker patients with AHRE than in those without , but the available data also show that stroke risk in patients with AHRE is lower than in patients with AF . Furthermore , only a minority of patients with AHRE will develop AF , many strokes occur without a temporal relation to AHRE , and AHRE can reflect other arrhythmias than AF or artifacts . An adequately powered controlled trial of oral anticoagulation in patients with AHRE is needed . Design The Non – vitamin K antagonist Oral anticoagulants in patients with Atrial High rate episodes ( NOAH – AFNET 6 ) trial tests whether oral anticoagulation with edoxaban is superior to prevent the primary efficacy outcome of stroke or cardiovascular death compared with aspirin or no antithrombotic therapy based on evidence ‐based indications . The primary safety outcome will be major bleeding . NOAH – AFNET 6 will r and omize 3,400 patients with AHRE , but without documented AF , aged ≥65 years with at least 1 other stroke risk factor , to oral anticoagulation therapy ( edoxaban ) or no anticoagulation . All patients will be followed until the end of this investigator‐driven , prospect i ve , parallel‐group , r and omized , event‐driven , double‐blind , multicenter phase IIIb trial . Patients will be censored when they develop AF and offered open‐label anticoagulation . The sponsor is the Atrial Fibrillation NETwork ( AFNET ) . The trial is supported by the DZHK ( German Centre for Cardiovascular Research ) , the BMBF ( German Ministry of Education and Research ) , and Daiichi Sankyo Europe . Conclusion NOAH – AFNET 6 will provide robust information on the effect of oral anticoagulation in patients with atrial high rate episodes detected by implanted devices . Graphical abstract Figure . No Caption available Background / Aims : Low rates and poor quality of oral anticoagulation ( OAC )  have been reported in patients with atrial fibrillation ( AF ) . We therefore sought to investigate the prescription patterns at discharge , adherence and quality of OAC in cerebrovascular disease patients with AF . Methods : Consecutive ischemic stroke ( IS ) and transient ischemic attack ( TIA ) patients were prospect ively documented in 11 German stroke centers . A central telephone follow-up after 1–2 years assessed the current antithrombotic medication and results of coagulation checks . Results : Of 1,463 surviving patients with AF , 30.5 % were discharged on OAC and 13.9 % on high-dose heparin . Of 329 AF patients discharged on OAC  and with consent for follow-up , 88.7 % of surviving patients were still on OAC at the follow-up . Of these , 52.7 % reported coagulation values out of the therapeutic range during the preceding 3 months . A recurrent IS was seen in 9 patients ( 2.1%/year ) and an intracranial hemorrhage in 2 . Conclusion : We found an important underuse of  OAC  following TIA or IS mainly in older patients and with greater stroke-related disability . Although the reported coagulation checks showed an only moderate rate within therapeutic ranges , safety and efficacy of OAC in this cohort seem comparable to previous r and omized and observational trials in AF patients BACKGROUND Percutaneous left atrial appendage closure ( LAAC ) may be considered in patients with atrial fibrillation and contraindication for long-term anticoagulation . This study aim ed to assess the safety and efficacy of LAAC followed by single antiplatelet therapy in patients with atrial fibrillation and previous spontaneous intracerebral hemorrhage ( ICH ) . METHODS In this explorative , prospect i ve , single-center study , consecutive patients who underwent LAAC because of previous spontaneous ICH over a period of 4 years were analyzed . Risks of ischemic strokes and hemorrhagic complications were estimated using the CHA2DS2-VASc and HAS-BLED scores , respectively . Single antiplatelet therapy was given for at least 6 months post implantation . Clinical follow-up included cardiological evaluations at 1 , 3 , 6 , and 12 months , and neurological evaluations at 3 and 12 months . RESULTS A total of 46 patients  underwent LAAC with a mean follow-up of 12 ± 7 months . The observed annual rate of ischemic stroke was 4.35 % compared with an expected rate of 7.23 % according to the mean risk of the population based on CHA2DS2-VASc score , which translated into a 40 % risk reduction . The observed annual rate of major bleeding was 4.35 % compared with an expected rate of 8.05 % according to the mean risk of the population based on HAS-BLED score , which translated into a 46 % risk reduction . CONCLUSIONS LAAC followed by single antiplatelet therapy is feasible as an alternative to oral anticoagulation in high-risk patients with previous ICH , with an acceptable periprocedural risk . Longer follow-up in a larger number of patients will be needed to establish the effectiveness of LAAC relative to direct oral anticoagulants Background and Purpose — There are limited real-world data comparing the effectiveness and safety of non-vitamin K antagonist oral anticoagulants ( NOACs ) and warfarin in Asians with nonvalvular atrial fibrillation . We aim ed to compare the effectiveness and safety between NOACs and warfarin users in the Korean atrial fibrillation population , with particular focus on high-risk patients . Methods — Using the Korean National Health Insurance Service data base , we analyzed the risk of ischemic stroke , intracranial hemorrhage ( ICH ) events , and all-cause death in  NOAC users ( n=11 611 total , n=5681 taking rivaroxaban , n=3741 taking dabigatran , and n=2189 taking apixaban ) compared with propensity score-matched warfarin users ( n=23 222 ) among patients with high-risk atrial fibrillation ( CHA2DS2-VASc score ≥2 ) between 2014 and 2015 . Results — NOAC treatment was associated with similar risk of ischemic stroke and lower risk of ICH and all-cause mortality compared with warfarin . All 3 NOACs were associated with a similar risk of ischemic stroke and a lower risk of ICH compared with warfarin . Dabigatran and apixaban were associated with a lower risk of total mortality and the composite net clinical outcome ( ischemic stroke , ICH , and all-cause death ) compared with warfarin , whereas this was nonsignificant for rivaroxaban . Among previously oral anticoagulant – naive patients ( n=23 262 ) , dabigatran and apixaban were superior to warfarin  for ICH prevention , whereas rivaroxaban and warfarin were associated with similar risk of ICH . Conclusions — In real-world practice among a high-risk Asian atrial fibrillation population , all 3 NOACs demonstrated similar risk of ischemic stroke and lower risk of ICH  compared with warfarin . All-cause mortality was significantly lower only with dabigatran and apixaban IMPORTANCE Intracerebral hemorrhage ( ICH ) is the most devastating adverse event in patients receiving oral anticoagulation .  There is only sparse evidence regarding ICH related to the use of non-vitamin K antagonist oral anticoagulant ( NOAC ) agents . OBJECTIVE To evaluate the early clinical and radiological course , acute management , and outcome of ICH related to NOAC use . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve investigator-initiated , multicenter observational study . All diagnostic and treatment decisions , including administration of hemostatic factors ( eg , prothrombin complex concentrate ) , were left to the discretion of the treating physicians . The setting was 38 stroke units across Germany ( February 1 , 2012 , to December 31 , 2014 ) . The study included 61 consecutive patients with nontraumatic NOAC-associated ICH , of whom 45 ( 74 % ) qualified for the hematoma expansion analysis . MAIN OUTCOMES AND MEASURES Hematoma expansion , intraventricular hemorrhage , and reversal of anticoagulation during the acute phase . Recorded were the 3-month functional outcome , factors associated with an unfavorable outcome ( modified Rankin Scale score , 3 - 6 ) , any new intraventricular extension or an increase in the modified Graeb score by at least 2 points , and the frequency of substantial hematoma expansion ( defined as relative [ ≥ 33 % ] or absolute [ ≥ 6-mL ] volume increase ) . RESULTS In total , 41 % ( 25 of 61 ) of patients with NOAC-associated ICH were female , and the mean ( SD ) patient age was 76.1 ( 11.6 ) years . At admission , the median National Institutes of Health Stroke Scale score was 10 ( interquartile range , 4 - 18 ) . The mean ( SD ) baseline hematoma volume was 23.7 ( 31.3 ) mL. In patients with sequential imaging for the hematoma expansion analysis , substantial hematoma expansion occurred in 38 % ( 17 of 45 ) . New or increased intraventricular hemorrhage was observed in 18 % ( 8 of 45 ) . Overall mortality was 28 % ( 17 of 60 [ follow-up data were missing in 1 patient ] ) at 3 months , and 65 % ( 28 of 43 ) of survivors had an unfavorable outcome ( modified Rankin Scale score , 3 - 6 ) . Overall , 57 % ( 35 of 61 ) of the patients received prothrombin complex concentrate , with no statistically significant effect on the frequency of substantial hematoma expansion ( 43 % [ 12 of 28 ] for prothrombin complex concentrate vs 29 % [ 5 of 17 ] for no prothrombin complex concentrate , P = .53 ) , or on the occurrence of an unfavorable outcome ( modified Rankin Scale score , 3 - 6 ) ( odds ratio , 1.20 ; 95 % CI , 0.37 - 3.87 ; P = .76 ) . CONCLUSIONS AND RELEVANCE Non-vitamin K antagonist oral anticoagulant-associated ICH has a high mortality and an unfavorable outcome , and hematoma expansion is frequent . Larger-scale prospect i ve studies are needed to determine whether the early administration of specific antidotes can improve the poor prognosis of NOAC-associated ICH Objectives The first non-vitamin K antagonist oral anticoagulant ( NOAC ) introduced to the market in Japan was dabigatran in March 2011 , and three more NOACs , rivaroxaban , apixaban , and edoxaban , have since become available . R and omized controlled trials of NOACs have revealed that intracranial hemorrhage ( ICH ) occurs less frequently with NOACs compared with warfarin . However , the absolute incidence of ICH associated with NOACs has increased with greater use of these anticoagulants , and we wanted to explore the incidence , clinical characteristics , and treatment course of patients with NOACs-associated ICH . Methods We retrospectively analyzed the characteristics of symptomatic ICH patients receiving NOACs between March 2011 and September 2014 . Results ICH occurred in 6 patients ( 5 men , 1 woman ; mean ± SD age , 72.8 ± 3.2 years )  . Mean time to onset was 146.2 ± 111.5 days after starting NOACs . Five patients received rivaroxaban and 1 patient received apixaban . None received dabigatran or edoxaban .  Notably , no hematoma expansion was observed within 24 h of onset in the absence of infusion of fresh frozen plasma , activated prothrombin complex concentrate , recombinant activated factor VIIa or hemodialysis . When NOAC therapy was initiated , mean HAS-BLED and PANWARDS scores were 1.5 ± 0.5 and 39.5 ± 7.7 , respectively . Mean systolic blood pressure was 137.8 ± 15.9 mmHg within 1 month before spontaneous ICH onset . Conclusion Six symptomatic ICHs occurred early in NOAC therapy but hematoma volume was small and did not exp and in the absence of infusion of reversal agents or hemodialysis . The occurrence of ICH during NOAC therapy is possible even when there is acceptable mean systolic blood pressure control ( 137.8 ± 15.9 mmHg ) and HAS-BLED score ≤ 2 . Even stricter blood pressure lowering and control within the acceptable range may be advisable to prevent ICH during NOAC therapy Objective : To compare  intracerebral hemorrhage (  ICH  ) volume and clinical outcome of non – vitamin K oral anticoagulants (NOAC)–associated ICH to warfarin-associated ICH . Methods : In this multicenter cross-sectional observational study of patients with anticoagulant-associated ICH , consecutive patients with NOAC-ICH were compared to those with warfarin-ICH selected from a population of 344 patients with anticoagulant-associated ICH .  ICH volume was measured by an observer blinded to clinical details . Outcome measures were ICH volume and clinical outcome adjusted for confounding factors . Results : We compared 11 patients with NOAC-ICH to 52 patients with warfarin-ICH .  The median ICH volume was 2.4 mL ( interquartile range [ IQR ] 0.3–5.4 mL ) for NOAC-ICH vs 8.9 mL ( IQR 4.0–21.3 mL ) for warfarin-ICH ( p = 0.0028 ) . In univariate linear regression , use of warfarin ( difference in cube root volume 1.61 ; 95 % confidence interval [ CI ] 0.69 to 2.53 ) and lobar ICH location ( compared with nonlobar ICH ; difference in cube root volume 1.52 ; 95 % CI 2.20 to 0.85 ) were associated with larger ICH volumes . In multivariable linear regression adjusting for confounding factors ( sex , hypertension , previous ischemic stroke , white matter disease burden , and premorbid modified Rankin Scale score [ mRS ] ) , warfarin use remained independently associated with larger ICH ( cube root ) volumes ( coefficient 0.64 ; 95 % CI 0.24 to 1.25 ; p = 0.042 ) . Ordered logistic regression showed an increased odds of a worse clinical outcome ( as measured by discharge mRS ) in warfarin-ICH compared with NOAC-ICH : odds ratio 4.46 ( 95 % CI 1.10 to 18.14 ; p = 0.037 ) . Conclusions : In this small prospect i ve observational study , patients with NOAC-associated ICH had smaller ICH volumes and better clinical outcomes compared with warfarin-associated ICH Background : For patients who survive intracerebral haemorrhage ( ICH ) during treatment with oral anticoagulation ( OAC )  , the balance between the benefits and risks of restarting OAC is unclear . The decision to restart OAC or to start antiplatelet therapy in these patients therefore poses a dilemma for all physicians involved . We assessed the long-term outcome of patients who did or did not restart antithrombotic therapy after OAC-associated ICH . Methods : We conducted a retrospective follow-up study of all patients discharged from our institution after OAC-associated ICH over a 10-year period . Data on the use of OAC or platelet inhibitors and the occurrence of vascular events during follow-up were assessed through question naires and patient files . The primary outcome was recurrent fatal or non-fatal stroke . Secondary outcomes were the occurrence of other haemorrhagic , thrombotic or thromboembolic events . With patients without antithrombotic treatment as reference , we calculated incidence ratios with corresponding 95 % confidence intervals ( CI ) for treatment with OAC and for treatment with antiplatelet therapy . Results : We included 38 patients , of whom 21 ( 55 % ) died during a mean follow-up of 3.5 years . The medication regime changed frequently during follow-up , illustrated by the fact that two thirds of the patients who had resumed OAC within 2 months of ICH terminated this at later points in time . Two recurrent strokes occurred during 35.4 patient-years without antithrombotic medication , 7 during 63.8 patient-years on antiplatelet medication ( incidence ratio 1.9 ; 95 % CI , 0.4 - 9.4 ) , and 3 during 19.5 patient-years on OAC ( incidence ratio 2.7 ; 95 % CI , 0.5 - 16.3 ) . There was only 1 recurrent ICH , which occurred during treatment with OAC . Conclusion : In this observational study , no significant difference in the primary outcome measure was found between the treatment groups , but there was a tendency towards a higher long-term risk of any stroke in patients who resumed OAC or started antiplatelet therapy . However , based on these results it is difficult to draw any concrete conclusions or make any strong recommendations . A r and omized trial to assess the optimal long-term strategy after OAC-related ICH is warranted . Based on the point estimates of our study , such a trial should involve at least 300 patient-years of follow-up BACKGROUND A number of studies have demonstrated the efficacy of oral anticoagulant therapy in reducing the risk of stroke and systemic embolism in patients with nonrheumatic atrial fibrillation . However , both the targeted and the actual levels of anticoagulation differed widely among the studies , and a number of studies failed to report st and ardized prothrombin-time ratios as international normalized ratios ( INRs ) . We therefore performed an analysis to determine the intensity of oral anticoagulant therapy in nonrheumatic atrial fibrillation that provides the best balance between the prevention of thromboembolism and the occurrence of bleeding complications . METHODS We calculated INR-specific incidence rates for both ischemic and major hemorrhagic events occurring in 214 patients who received anticoagulant therapy in the European Atrial Fibrillation Trial , a secondary -prevention trial in patients with nonrheumatic atrial fibrillation and a recent episode of minor cerebral ischemia . RESULTS The optimal intensity of anticoagulation was found to lie between an INR of 2.0 and an INR of 3.9 . No treatment effect was apparent with anticoagulation below an INR of 2.0 . The rate of thromboembolic events was lowest at INRs from 2.0 to 3.9 , and most major bleeding complications occurred with treatment at intensities with INRs of 5.0 or above . CONCLUSIONS To achieve optimal levels of anticoagulation with the lowest risk in patients with atrial fibrillation and a recent episode of cerebral ischemia , the target value for the INR should be set at 3.0 , and values below 2.0 and above 5.0 should be avoided Background and Purpose — Patients treated with oral anticoagulants ( ACs )  have an increased risk of intracerebral hemorrhage ( ICH ) , which is more often fatal than spontaneous ICH . Options to reverse the AC effect include intravenous administration of vitamin K , plasma , and coagulation factor concentrate . However , the optimal management of AC-related ICH has not been determined in any r and omized trial . In this study , the present management of AC-related ICH was surveyed , and determinants of survival were assessed . Methods — We retrospectively review ed the medical records of all AC-related ICHs at 10 Swedish hospitals during a 4-year period , 1993 to 1996 .  Survival status after the ICH was determined from the Swedish National population register . Results — We identified 151 patients with AC-related ICH .  Death rates were 53.6 % at 30 days , 63.6 % at 6 months , and 77.5 % at follow-up ( mean 3.5 years ) . The case fatality ratio at 30 days was 96 % among patients unconscious on admission ( n=27 ) , 80 % among patients who became unconscious before active treatment was started ( n=15 ) , 55 % among patients in whom no special action was taken except withdrawal of AC treatment ( n=42 ) , and 28 % among patients given active anti-coumarin treatment while they were still conscious ( n=64 ) . The case fatality ratio at 30 days was 11 % in the group treated with plasma ( n=18 ) , 30 % in the group treated with vitamin K ( n=23 ) , and 39 % in the group treated with coagulation factor concentrate ( n=23 ) . Within the first 24 to 48 hours after admission , 47 % of the patients deteriorated . Choice of therapy to reverse the AC effect differed substantially between the hospitals ( P < 0.0001 ) , as did the time interval from symptom onset to start of treatment . Multiple logistic regression analysis showed only 2 factors ( intraventricular extension of bleeding and ICH volume ) that were independently related to case fatality at both 30 days and 6 months . The results were similar when the analysis was restricted to patients who were conscious on admission . Conclusions — In AC-related ICH , a progressive neurological deterioration during the first 24 to 48 hours after admission is frequent , and the mortality is high . Choice of therapy to reverse the AC effect differed considerably between the hospitals . There was no evidence that any treatment strategy was superior to the others . A r and omized controlled trial is needed to determine the best choice of treatment It has been observed that elderly patients with nonvalvular atrial fibrillation ( NVAF ) benefit from st and ard [ an international normalised ratio ( INR ) goal of 2.0 - 3.0 ] oral anticoagulant treatment ( OAT ) . The hypothesis that lower-intensity anticoagulation therapy can offset the higher bleeding risk in this population has never been tested in an ' ad hoc ' clinical trial . Patients over 75 years of age with NVAF were r and omised to receive warfarin to maintain the INR at 1.8 ( range 1.5 - 2.0 ) or at a st and ard target of 2.5 ( range 2.0 - 3.0 ) . There were 135 patients in the low-intensity and 132 in the st and ard-intensity groups . During a mean follow-up lasting 5.1 years , 59 primary outcome events ( thromboembolism and major haemorrhage ) were recorded , 24 ( 3.5 per 100 patient-years ) in the low-intensity group and 35 ( 5.0 per 100 patient-years ) in the st and ard-intensity group ( HR=0.7 , 95 % CI 0.4 - 1.1 , p=0.1 ) . The reduction in the primary endpoint was mainly due to a diminution in major bleedings ( 1.9 vs. 3.0 per 100 patient-years ; HR=0.6 , 95 % CI 0.3 - 1.2 , p=0.1 ) . The median achieved INR value was 1.86 in the low-intensity and 2.24 in the st and ard-intensity group ( p<0.001 ) . The frequency of INR testing was 26.1 + /- 13.5 vs. 24.3 + /- 11.6 days , p<0.0001 ) . In this exploratory study we observed a low rate of stroke and major bleeding in elderly patients ( > 75 ) being managed in an anticoagulation clinic for primary stroke prevention with low-intensity anticoagulation ( INR 1.5 - 2.0 ) . However , further trials are needed to confirm the hypothesis generated by the present study BACKGROUND Real-world data on patients ' and physicians ' values related to the use of oral anticoagulant ( OAC ) therapy for stroke prevention in patients with nonvalvular atrial fibrillation are currently lacking . We sought to assess the values , preferences , and experience of patients who receive OAC therapy , and of physicians who prescribe OAC therapy .  METHODS A national survey of r and omly selected patients ( n = 266 ) and physicians ( n = 178 ) was conducted between May and September 2014 . Each was asked to evaluate the importance of individual  OAC  attributes and identify which of 2 medication profiles they would prefer ( individual attributes were progressively modified to determine which were the most valued and /or influenced treatment choice ) . Medication adherence and prescription practice was also assessed . RESULTS The preferences of patients and physicians regarding OAC therapy differed but largely focused on characteristics related to safety and , to a lesser extent , efficacy . When based solely on the basis of the attribute profile ( blinded to the specific agent ) , physicians were more likely to select apixaban ( 61 % ) , whereas patients showed no significant preference among apixaban , rivaroxaban , and warfarin . Despite this , 49 % of physicians spontaneously stated rivaroxaban as their preferred agent ( vs 25 % apixaban ) . Patients prescribed and taking once daily medications ( rivaroxaban or warfarin ) showed better compliance with their OAC therapy ( approximately 30 % of twice daily medications being taken once daily , with significantly more missed doses compared with once daily medications ) . CONCLUSIONS Real-world prescriptions do not reflect reported values , which suggests that other factors influence patient-physician decision-making around OAC therapy . Data on self-reported adherence to OAC therapy and discordance in the use of OACs from prescribed regimens are concerning and warrant further investigation 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 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 ) OBJECTIVES This trial evaluated the efficacy and safety of the combination of antiplatelet and moderate-intensity anticoagulation therapy in patients with atrial fibrillation associated with recognized risk factors or mitral stenosis . BACKGROUND Warfarin was more effective than aspirin in preventing stroke in these patients ; combined therapy with low anticoagulant intensity was ineffective . Mitral stenosis patients were not investigated . METHODS We performed a multicenter r and omized trial in 1,209 patients at risk . The intermediate-risk group included patients with risk factors or age > 60 years : 242 received the cyclooxygenase inhibitor triflusal  , 237 received  acenocumarol , and 235 received a combination of both .  The high-risk group included patients with prior embolism or mitral stenosis : 259 received anticoagulants and 236 received the combined therapy . Median follow-up was 2.76 years . Primary outcome was a composite of vascular death and nonfatal stroke or systemic embolism . RESULTS Primary outcome was lower in the combined therapy than in the anticoagulant arm in both the intermediate- ( hazard ratio [ HR ] 0.33 [ 95 % confidence interval (CI)0.12 to 0.91 ] ; p = 0.02 ) and the high-risk group ( HR 0.51 [ 95 % CI 0.27 to 0.96 ] ; p = 0.03 ) . Primary outcome plus severe bleeding was lower with combined therapy in the intermediate-risk group . Nonvalvular and mitral stenosis patients had similar embolic event rates during anticoagulant therapy . CONCLUSIONS The combined antiplatelet plus moderate-intensity anticoagulation therapy significantly decreased the vascular events compared with anticoagulation alone and proved to be safe in atrial fibrillation patients AIMS Experiences with novel oral anticoagulants ( NOACs )  early after atrial fibrillation ( AF ) catheter ablation are limited and show controversial results . We aim ed to assess the longer-term safety , efficacy , and acceptance of NOACs in a large real-world cohort of patients presenting for AF catheter ablation . METHODS AND RESULTS From July 2010 until June 2012 , 259 patients undergoing AF catheter ablation were prospect ively included .  Novel oral anticoagulants were given for at least 3 months post-ablation . Clinical outcome ( stroke , thromboembolic events , major bleeding ) , adverse effects , and drug adherence were assessed at discharge and follow-up . On admission patients were presented with a variety of  anticoagulants  including 54 patients ( 21 % ) already on NOACs prior ablation . After ablation 38 % of patients received dabigatran 110 mg , 56 % 150 mg , and 6 % received rivaroxaban 20 mg . There were four periprocedural thromboembolic and major bleeding complications ( 1.5 % ) , all in patients without NOACs prior ablation ( two on warfarin and two on heparin ) . During long-term follow-up [ 311 ( 199 ; 418 ) days ] no stroke , systemic embolism , or major haemorrhage could be observed . Uneventful electrical cardioversions and reablation procedures were performed in 27 and 12 patients on dabigatran , respectively . Novel oral anticoagulants were prematurely stopped or switched to another anticoagulant due to side effects or at the preference of the treating general practitioner in 9 and 10 patients , respectively . CONCLUSION In this prospect i ve observational study , anticoagulation with NOACs following AF catheter ablation was safe and effective at long-term follow-up . Fast onset of action makes NOACs especially attractive in patients without effective anticoagulation on admission and in patients following periprocedural complications The objective of this open , r and omized , multicenter study is to investigate the benefits and economic efficiency of  self-management of oral anticoagulation in patients with atrial fibrillation ( SMAAF study ) in comparison with a group of patients given conventional care by a general practitioner or specialist . Two thous and patients suitable for self-management will be assigned at r and om to either the self-management group or the control group . The numbers of thromboembolic and hemorrhagic complications requiring treatment during the 2-year follow-up period will be recorded as the primary end point . The secondary endpoint variables will be maintenance of the INR value in the individual target range , INR variance , the course of complications over time , and the cost efficiency of self-management compared with the routine procedures . The last of these parameters will include the diagnostic and /or therapeutic measures carried out , the duration of inpatient hospital treatment , and the social consequences ( subsequent rehabilitation treatment , inability to work , forced retirement ) . The estimate of the required number of patients was based on the assumption that during long-term anticoagulant therapy within the framework of primary and secondary prevention 4 % of patients with chronic non-valvular atrial fibrillation would have severe thromboembolic of hemorrhagic complications each year . Since this rate can be halved by self-management , a one-tailed chi 2-test of 80 % power and a 5 % significance threshold would require n = 997 patients per group . The results of the SMAAF study will establish the socioeconomic benefits of self-management in patients with non-valvular atrial fibrillation
In addition , 19 letters to the editor/ review s/editorials/experts ' surveys/experts ' opinion were used for discussion purpose s. Conclusions NVAF is highly prevalent among ICH survivors .
The risks of IS , recurrent ICH , and mortality are heightened in this group .
Most published data show a net benefit in terms of IS prevention and mortality when anticoagulation is restarted .
Background We summarize the existing evidence on the potential benefit of oral anticoagulation ( OAC ) in intracerebral hemorrhage ( ICH ) survivors with nonvalvular atrial fibrillation ( NVAF ) .