P4773Oral anticoagulants in patients with atrial fibrillation having an intermediate risk of ischemic stroke but a high risk of bleeding

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
T F Chao ◽  
S A Chen

Abstract Background The use of oral anticoagulants (OACs) for patients with atrial fibrillation (AF) for stroke prevention should be balanced between the reduction on stroke risk and the increase in bleeding. Our aim was to investigate net clinical benefits of OACs among AF patients with a CHA2DS2-VASc score of 1 (males) or 2 (females) who had a HAS-BLED score ≥3. Method A total of 404,949 newly diagnosed AF patients were identified from the Taiwan National Health Insurance Research Database. The stroke risk was assessed using the CHA2DS2-VASc score and patients were classified as low (score 0 for males, 1 for females), intermediate (1 for males and 2 for females) and high risk (≥2 for males and ≥3 for females). A high risk of bleeding was defined as a HAS-BLED score ≥3. Results The CHA2DS2-VASc and HAS-BLED scores were significantly correlated (r=0.70). Around 72.7% of patients with a high-risk of stroke had a HAS-BLED score ≥3 (Figure A). Among patients with a CHA2DS2-VASc score of 1 (males) or 2 (females) who had a HAS-BLED score ≥3, the use of OACs was associated with a lower risk of adverse events (ischemic stroke, intra-cranial hemorrhage or mortality) with an adjusted hazard ratio of 0.781 (p=0.037) (Figure B). Conclusion Even among patients with an intermediate risk of ischemic stroke (CHA2DS2-VASc score 1 for males, 2 for females) having a high risk for bleeding (HAS-BLED score ≥3), use of OACs was associated with a better clinical outcome and should still be considered.

2020 ◽  
Vol 16 (5) ◽  
pp. 686-692
Author(s):  
O. V. Reshetko ◽  
A. V. Sokolov ◽  
N. V. Furman ◽  
V. V. Agapov

Aim. To study the changes that have occurred in the pharmacotherapy of atrial fibrillation (AF) in the Saratov Region for 5 years by analyzing the antithrombotic therapy of patients who were admitted in a specialized department of the multidisciplinary hospital in Saratov in 2011-2012 and in 2016-2017.Material and methods. A pharmacoepidemiological retrospective study was conducted. The object of the study was the medical records of inpatients (Form 003/y) with the diagnosis “Atrial fibrillation” (ICD-X code I48), that consecutively admitted to the cardiology department of the multidisciplinary hospital in Saratov from January 1, 2011 to December, 31, 2012 (n=211) and from January 1, 2016 to December, 31, 2017 (n=227). Criteria for inclusion in the study: patients over 18 years of age, established diagnosis of non-valvular AF of ischemic genesis. Exclusion criteria from the study: non-ischemic cardiomyopathy, thyrotoxicosis, congenital heart defects, rheumatic heart damage, acute coronary syndrome, endocarditis, myocarditis, pericarditis, pulmonary thromboembolism, the presence of prosthetic heart valve. Pharmacoepidemiological analysis was carried out for the drugs prescribed during hospitalization and given by doctors at discharge of patients from the hospital. The risk of ischemic stroke was assessed using the CHA2DS2-VASc score, and the risk of bleeding – according to the HAS-BLED score.Results. When analyzing the risk of ischemic stroke, it was found that 100% of patients in 2011-2012 years and 98.2% in 2016-2017 years had indications for the prescription of oral anticoagulants (OAСs). In 2011-2012 there were no patients with a low risk of stroke (CHA2DS2-VASc=0). High risk of bleeding (HAS-BLED≥3) occurred in 4.7% of patients in 2011-2012 and in 10.6% in 2016-2017, however, due to the high risk of stroke, the refusal to prescribe OAC in these patients was inappropriate in accordance with the recommendations for the treatment of AF. In the group of patients with CHA2DS2-VASc=0 in 2016-2017 antiplatelet therapy was prescribed in 100% at the hospital stage and at discharge, which contradicts the guidelines, according to which antithrombotic therapy is not recommended to patients with CHA2DS2-VASc=0. In patients with CHA2DS2-VASc=1, a low percentage of anticoagulants prescription was noted. In 2016-2017 OACs were prescribed only in 12.5% of patients at all stages of observation. In 2011-2012 OAC alone was prescribed only to 1 person (20%) at the hospital stage, which does not comply with modern guidelines for the treatment of patients with AF, according to which patients with a risk score CHA2DS2-VASc=1 are recommended to receive OACs in the absence of contraindications. OACs prescription in group CHA2DS2-VASc≥2 occurred only in 15% of patients in 2011-2012 and in a third of patients in 2016-2017 (p<0.05). The frequency of isolated use of OACs significantly increased in 2016-2017 compared to 2011-2012 mainly due to the increase in the spectrum of direct OACs (DOACs) (p<0.05).Conclusion. For 5 years there have been significant changes in the antithrombotic therapy of AF in the Saratov Region. The frequency of prescribing OACs according to indications has increased mainly due to the introduction of the DOACs into clinical practice. However, prevention of stroke remains insufficient.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
T F Chao ◽  
S A Chen

Abstract Background Patients with atrial fibrillation (AF) having a history of intracranial hemorrhage (ICH) were excluded from the pivotal randomized trials comparing direct oral anticoagulants (DOACs) and warfarin. We aimed to compare the effectiveness and safety of DOACs and warfarin among AF patients having a history of ICH. Method A total of 4,540 AF patients having a CHA2DS2-VASc score ≥1 for males and ≥2 for females who had a history of ICH and received oral anticoagulants (DOACs in 3,493 and warfarin in 1,047) were identified from the Taiwan National Health Insurance Research Database. A propensity matching analysis was performed to balance the baseline differences, and 973 patients were finally identified in each groups. Results The risk of ischemic stroke did not differ significantly between warfarin and DOACs (4.41%/yr vs 4.87%/yr; HR 0.985, p=0.927). The risks of bleeding events were lower with DOACs compared to warfarin with a HR (95% CI) of 0.752 (0.573–0.986, p=0.040) for major bleeding and 0.614 (0.379–0.995, p 0.048) for ICH. The risk of mortality was also lower in patients treated with DOACs (HR = 0.539; 95% CI = 0.453–0.642, p<0.001). The cumulative incidence curves of each events for 2 groups are shown in Figure. Conclusion Compared to warfarin, DOACs were associated with a similar risk of ischemic stroke and better safety profiles among AF patient with a history of ICH.


2017 ◽  
Vol 37 (suppl_1) ◽  
Author(s):  
Hong Seok Lee

Background: Oral anticoagulants known as a novel oral anticoagulant have been used for the management of non -valvular atrial fibrillation. There was no enough study regarding the efficacy and safety of three major new oral anticoagulants. We assessed major three oral anticoagulants in terms of major bleeding complication and stroke prevention by meta-analyses studies comparing those drugs. Method: Relevant studies were identified through electronic literature searches of MEDLINE, EMBASE, Cochrane library, and clinicaltrials.gov (from inception to February 24, 2016). RevMan and ITC software were used for direct comparisons, respectively. Results: Apixaban (N=6020), versus dabigatran(N=12038), apixaban versus rivaroxaban(N=8503) and rivaroxaban versus dabigatran were analyzed directly. There was significantly higher major bleeding risks in apixaban compared to dabigatran (both 110mg and 150mg) after adjusting baseline bleeding risk (Relative risk 3.41, 95% confidence interval(2.61 to 4.47) in 110mg, (5.62, 4.83 to 6.54) in 150mg. Intracranial bleeding risk in apixaban was significantly higher than in dabigatran (10.5, 6.10 to18.01). However, apixaban had less GI bleeding risk compared to dabigatran (0.80 , 0.65 to 0.98) and also had less ischemic stroke risk (0.31,0.22 to 0.42). Rivaroxaban showed higher major bleeding risk than dabigatran 110mg (2.34 , 1.81 to 3.03), however, Rivaroxaban had less bleeding risk compared to dabigatran 150mg (0.41, 0.35 to 0.46). Dabigatran 110mg and 150mg had less GI bleeding risk compared to rivaroxaban (0.31 , 0.24 to 0.39) and (0.23,0.17 to 0.29) respectively. Ischemic stroke risk was also decreased in dabigatran110mg (0.46, 0.38 to 0.57). and 150mg (0.66 ,0.52 to 0.83). Conclusion: Observed oral anticoagulants were associated with various complications. Overall, apixaban had higher intracranial bleeding risk than dabigatran. The highest GI bleeding risk in rivaroxaban compared to apixaban and dabigatran. Ischemic stroke risk was the highest in dabigatran. In conclusion, we may use those oral anticoagulant based on risks rates, however, a larger study with longer follow-up is needed to corroborate findings.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
K M Lee ◽  
M H Kim ◽  
S Y Choi ◽  
S J Kim ◽  
S W Kim ◽  
...  

Abstract Background Although older age is one of the most important risk factor for stroke in atrial fibrillation (AF), it is unclear whether oral anticoagulants are beneficial for AF patients with intermediate CHA2DS2-VASc score (1 for male or 2 for female) according to age threshold. We sought to investigate the effect of age-dependent antithrombotic therapy for ischemic stroke in Korean intermediate risk AF patients. Methods We enrolled 29,592 patients (males with CHA2DS2-VASc score of 1 and females with CHA2DS2-VASc score of 2) using the Korean National Health Insurance Service database. The clinical endpoint was the occurrence of ischemic stroke. The propensity score matching method was used to balance covariates across treated and untreated patients. Results Treated male AF patients were 6,570 (67.1%) with age <55 years, 7,115 (70.9%) with 55–64 years and 6,470 (68.3%) with 65–74 years in each age risk criterion. Also, treated female AF patients were 3,156 (71.3%) with age <55 years, 2,838 (71.0%) with 55–64 years and 3,440 (72.6%) with 65–74 years in each age risk criterion. Among male and female patients (age <55 years and 55–64 years) with 1 risk factor, an annual ischemic stroke rate was not significantly different between treated and untreated patients at full follow-up. However, treated AF patients who are in age 65–74 year without other risk factor had a much lower annual risk of ischemic stroke [(1.05%/year (male) and 1.04%/year (female)] compared with untreated patients [(1.77%/year (male) (p<0.026) and 1.86%/year (female) (p<0.041). Conclusions Age is an important predictor in determining the risk of ischemic stroke in AF patients with intermediate CHA2DS2-VASc scores (1 for male or 2 for female). We suggest that the benefit of anti-thrombotic therapy for intermediate risk AF patients depends on age threshold.


Medicina ◽  
2019 ◽  
Vol 55 (10) ◽  
pp. 626 ◽  
Author(s):  
Anna Poggesi ◽  
Carmen Barbato ◽  
Francesco Galmozzi ◽  
Eleonora Camilleri ◽  
Francesca Cesari ◽  
...  

Background and Objectives: In anticoagulated atrial fibrillation (AF) patients, the validity of models recommended for the stratification of the risk ratio between benefits and hemorrhage risk is limited. Cerebral small vessel disease (SVD) represents the pathologic substrate for primary intracerebral hemorrhage and ischemic stroke. We hypothesize that biological markers—both circulating and imaging-based—and their possible interaction, might improve the prediction of bleeding risk in AF patients under treatment with any type of oral anticoagulant. Materials and Methods: The Strat-AF study is an observational, prospective, single-center hospital-based study enrolling patients with AF, aged 65 years or older, and with no contraindications to magnetic resonance imaging (MRI), referring to Center of Thrombosis outpatient clinic of our University Hospital for the management of oral anticoagulation therapy. Recruited patients are evaluated by means of a comprehensive protocol, with clinical, cerebral MRI, and circulating biomarkers assessment at baseline and after 18 months. The main outcome is SVD progression—particularly microbleeds—as a selective surrogate marker of hemorrhagic complication. Stroke occurrence (ischemic or hemorrhagic) and the progression of functional, cognitive, and motor status will be evaluated as secondary outcomes. Circulating biomarkers may further improve predictive potentials. Results: Starting from September 2017, 194 patients (mean age 78.1 ± 6.7, range 65–97; 61% males) were enrolled. The type of AF was paroxysmal in 93 patients (48%), and persistent or permanent in the remaining patients. Concerning the type of oral anticoagulant, 57 patients (29%) were on vitamin K antagonists, and 137 (71%) were on direct oral anticoagulants. Follow-up clinical evaluation and brain MRI are ongoing. Conclusions: The Strat-AF study may be an essential step towards the exploration of the role of a combined clinical biomarker or multiple biomarker models in predicting stroke risk in AF, and might sustain the incorporation of such new markers in the existing stroke prediction schemes by the demonstration of a greater incremental value in predicting stroke risk and improvement in clinical outcomes in a cost-effective fashion.


Author(s):  
Wen Sun ◽  
Ben FREEDMAN ◽  
Carlos Martinez ◽  
Christopher Wallenhorst ◽  
Bryan Yan

ABSTRACT Objective: We evaluated stroke risk in patients with single timepoint screen-detected atrial fibrillation (AF) and the effect of oral anticoagulants (OAC). Methods: Consecutive patients aged ≥65 years attending medical outpatient clinics were prospectively enrolled for AF-screening using handheld single-lead ECG (AliveCor) from 12/2014 to 12/2017 (NCT02409654). Repeated screening was performed in patients with >1 visit during this period. Three cohorts were formed, screen-detected AF, clinically-diagnosed AF and no AF. Ischemic stroke risk was estimated using adjusted sub-distribution hazard ratios (aSHR) from multivariate regression and no AF as reference, and stratified according to OAC use. Results: Of 11,972 subjects enrolled, 2,238 (18.7%) had clinically-diagnosed AF at study enrollment. The yield of screen-detected AF on initial screening was 2.3% (n=223/9,734). AF was clinically-diagnosed during follow-up in 2.3% (n=216/9,440) and during subsequent screening in 71 initially screen-negative patients. Compared to no AF, patients with screen-detected AF without OAC treatment had the highest stroke risk (aSHR 2.63; 95% confidence interval 1.46-4.72), while aSHR for clinically-diagnosed AF without OAC use was 2.01 (1.54-2.62). Among screen-detected AF the risk of stroke was significantly less with OAC (no strokes in 196 person-years) compared with those not given OAC (12 strokes in 429 person-years), p=0.01. Conclusion: The prognosis of single timepoint ECG screen-detected AF is not benign. The risk of stroke is high enough to warrant OAC use, and reduced by OAC. Keywords: atrial fibrillation, screening, ischemic stroke


Stroke ◽  
2020 ◽  
Vol 51 (6) ◽  
pp. 1772-1780
Author(s):  
Rungroj Krittayaphong ◽  
Arjbordin Winijkul ◽  
Rapeephon Kunjara-Na-Ayudhya ◽  
Sirin Apiyasawat ◽  
Khanchai Siriwattana ◽  
...  

Background and Purpose— Guideline adherent oral anticoagulant (OAC) management of patients with nonvalvular atrial fibrillation has been associated with improved outcomes, but limited data are available from Asia. We aimed to investigate outcomes in patients who received guideline compliant management compared with those who were OAC undertreated or overtreated, in a large nationwide multicenter cohort of patients with nonvalvular atrial fibrillation in Thailand. Methods— Patients with nonvalvular atrial fibrillation were prospectively enrolled from 27 hospitals—all of which are data contributors to the COOL-AF Registry (Cohort of Antithrombotic Use and Optimal INR Level in Patients With Non-Valvular Atrial Fibrillation in Thailand). Patients were categorized as follows: (1) guideline adherence group when OAC was given in high-risk or intermediate-risk, but not in low-risk patients; (2) undertreatment group when OAC was not given in the high-risk or intermediate-risk groups; and (3) overtreatment group when OAC was given in the low-risk group or when OAC was given in combination with antiplatelets without indication. Results— A total of 3327 patients who had follow-up clinical outcome data were included. The mean age of patients was 67.4 years and 58.1% were male. The numbers of patients in the guideline adherence group, undertreatment group, and overtreatment group were 2267 (68.1%), 624 (18.8%), and 436 (13.1%) patients, respectively. The overall rate of ischemic stroke, major bleeding, all bleeding, and death was 3.0%, 4.4%, 15.1%, and 7.8%, respectively. Undertreated patients had a higher risk of ischemic stroke and death compared with guideline adherent patients, and overtreated patients had a higher risk of bleeding and death compared with OAC guideline-managed patients. Conclusions— Adherence to OAC management guidelines is associated with improved clinical outcomes in Asian nonvalvular atrial fibrillation patients. Undertreatment or overtreatment was found to be associated with increased risk of adverse outcomes compared with guideline-adherent management.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
T.F Chao ◽  
J.N Liao ◽  
G.Y.H Lip ◽  
S.A Chen

Abstract Background Underuse of oral anticoagulants (OACs) for stroke prevention in patients with atrial fibrillation (AF) is a common issue in the daily practice. The introduction of non-vitamin K antagonist OACs (NOACs) has changed the landscape of stroke prevention in AF. The goal of the present study was to investigate the trends of use of OACs and severities of stroke among AF patients using a nationwide AF database. Methods The present study used the Taiwan Nationwide Health Insurance Research Database (NHIRD). From year 2002 to 2015, a total of 66,331 AF patients aged &gt;20 years who experienced ischemic stroke were identified from 447,259 AF patients. The temporal trends of use of OACs (either warfarin or NOACs) and the severities of stroke were analyzed. The estimated National Institutes of Health Stroke Scale (eNIHSS) calculated by 7-item NHIRD based stroke severity index, which has been validated before, was used to represent the stroke severities. Results The percentages of AF patients who were already anticoagulated when stroke occurred significantly increased from 20.3% in year 2002 to 40.5% in year 2015 (Figure A). The increment was more obvious in the era of NOACs (after year 2012 in Taiwan). In year 2015, NOACs accounts for around 69.6% of prescriptions of OACs. The mean eNIHSS gradually decreased from 17.3 (year 2002) to 14.3 (year 2015) (Figure B). Conclusions In the era of NOACs, the prescription rates of OACs significantly increased among AF patients who experienced ischemic stroke, temporally associated with a decrease in the stroke severity. Funding Acknowledgement Type of funding source: None


2020 ◽  
Vol 1 (2) ◽  
pp. 6
Author(s):  
Abed Nego Okthara Sebayang

ABSTRACT Atrial Fibrillation (AF) is an arrhythmia characterized by disorganization of atrial depolarization resulting in the impaired mechanical function of the atrium. Management of AF aims to prevent complications of ischemic stroke and systemic embolism, carried out by the administration of anticoagulant, warfarin, but warfarin has many side effects. New Oral Anticoagulants (NOAC) can be used as alternatives in preventing complications of AF.New anticoagulants such as dabigatran, rivaroxaban, and apixaban have better effects than other anticoagulants such as warfarin and have major side effects of bleeding and minimal relevant bleeding. Based on a national survey in Denmark to see a balance between stroke and intracranial bleeding, CHA2DS2-VASc 1 scores were only apixaban and both dabigatran doses (110 mg bid and 150 mg bid) which provided better clinical benefits than warfarin, but if the CHA2DS2- score VASc ≥2 of all NOACs is superior to warfarin. Atrial fibrillation can cause ischemic stroke and systemic embolism. New Oral Anticoagulant (NOACs) can be used as a solution to prevent complications from AF with minimal side effects. It is expected that the presence of new anticoagulants can reduce the rate of ischemic stroke and ischemic embolism due to AF with minimal side effects of bleeding and other side effects. Keywords: Anticoagulant,  Atrial Fibrillation, NOAC, Warfarin   ABSTRAK Atrial Fibrilasi (AF) adalah suatu aritmia yang ditandai dengan disorganisasi dari depolarisasi atrium sehingga berakibat pada gangguan fungsi mekanik atrium. Penatalaksanaan AF bertujuan mencegah komplikasiyakni stroke iskemik dan emboli sistemik, dilakukan dengan cara pemberian anti-koagulan yakni warfarin. Pemberian warfarin  memiliki banyak efek samping.  Novel Oral Anti Coagulants (NOAC) dapat dijadikan alternatif  dalam mencegah komplikasi AF. Anti-koagulan baru seperti dabigatran, rivaroxaban dan apixaban memiliki efektifitas yang lebih baik daripada anti-koagulan lainnya seperti warfarin dan memiliki efek samping perdarahan mayor dan perdarahan relevan yang minimal. Berdasarkan survei nasional di Denmark untuk melihat keseimbangan antara stroke dan perdarahan intra-kranial didapatkan bila skor Congestive heart failure, Hypertension, Age ≥75 years (skor 2), Diabetes mellitus, Stroke history (skor 2), peripheral Vascular disease, Age between 65 to 74 years, Sex Category (female) dan “C” adalah adanya disfungsi ventrikel kiri sedang hingga berat (Left Ventricular Ejection Fraction/LVEF ≤ 40%)  CHA2DS2-VASc  1 hanya apixaban dan kedua dosis dabigatran (110 mg b.i.ddan 150 mg b.i.d) yang memberikan manfaat klinis yang lebih baik daripada warfarin, tetapi apabila skor CHA2DS2-VASc ≥2 seluruh NOAC lebih superior dibanding warfarin.AF dapat menyebabkan stroke iskemik dan emboli sistemik.NOAC dapat dijadikan solusi untuk mencegah komplikasi dari AF dengan efek samping yang minimal. Diharapkan dengan hadirnya anti-koagulan baru dapat menurunkan angka stroke iskemik dan emboli iskemik akibat AF dengan efek samping perdarahan dan efek samping lainnya yang minimal. Kata Kunci: Antikoagulan, Atrial Fibrilasi, NOAC, Warfarin


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