Preventing Stroke in Patients with Atrial Fibrillation - Evidence Update for Clinicians

2020 ◽  
Author(s):  
Keyword(s):  
Atrial Fibrillation ◽  
General Population ◽  
Major Bleeding ◽  
Anticoagulation Therapy ◽  
Bleeding Risk ◽  
Nonvalvular Atrial Fibrillation ◽  
Administration Regimen ◽  
Increased Risk ◽  
All Cause Mortality

Patients with atrial fibrillation have a higher risk for stroke than the general population, and that risk increases markedly with age. Anticoagulation therapy lowers the risk of stroke and improves all-cause mortality. Warfarin has been the mainstay of anticoagulation therapy for decades but has an increased risk of major bleeding and requires a complicated administration regimen. A recent update of research adds to the evidence about the relative benefits and harms of newer anticoagulation therapies and tools to predict stroke related to atrial fibrillation and bleeding risk. This evidence on the newer therapies, along with recently updated guidelines on managing nonvalvular atrial fibrillation, can help inform clinician and patient decisions on anticoagulant use and may potentially reduce the risk of stroke and its consequences.

scholarly journals Impact of Polypharmacy and P-Glycoprotein- and CYP3A4-Modulating Drugs on Safety and Efficacy of Oral Anticoagulation Therapy in Patients with Atrial Fibrillation

2019 ◽  
Vol 33 (5) ◽  
pp. 615-623 ◽  
Author(s):  
Ralf E. Harskamp ◽  
Martina Teichert ◽  
Wim A. M. Lucassen ◽  
Henk C. P. M. van Weert ◽  
Renato D. Lopes
Keyword(s):  
Atrial Fibrillation ◽  
Intracranial Hemorrhage ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Anticoagulation Therapy ◽  
Adverse Outcomes ◽  
Safety And Efficacy ◽  
P Glycoprotein ◽  
Increased Risk ◽  
All Cause Mortality

Abstract Purpose To study whether polypharmacy or drug–drug interactions have differential effect on safety and efficacy in patients treated with direct oral anticoagulants (DOACs) versus warfarin. Methods We performed a systematic review and meta-analysis of studies that randomized patients with atrial fibrillation to DOACs or warfarin stratified by the number of concomitant drugs. Outcomes included stroke or systemic embolism (SE), all-cause mortality, major bleeding, and intracranial hemorrhage. Risk ratios (RR) were calculated and Mantel-Haenszel random effects were applied. Results Two high-quality studies were eligible, including 32,465 participants who received apixaban, rivaroxaban, or warfarin, with a median follow-up of 1.9 years. Of participants, 29% used < 5 drugs, 55% used 5–9 drugs, and 16% used ≥ 10 drugs. Drugs interacting with DOACs (P-glycoprotein/CYP3A4) were used by 6460 (20%) of patients. Patients with higher number of drugs (0–4 vs 5–9 vs ≥ 10) had higher rates of mortality (5.8%, 7.9%, 10.0%) and major bleeding (3.4%, 4.8%, 7.7%). Comparative efficacy or safety of DOACs versus warfarin was not affected by polypharmacy status or P-glycoprotein/CYP3A4 inhibitor use. However, the presence of polypharmacy (p = 0.001) or glycoprotein/CYP3A4-modulating drugs (p = 0.03) was correlated with increased risk of major bleeding when compared with warfarin. Overall, DOAC use was associated with a lower risk of stroke/SE (RR, 0.84; 95%CI, 0.74–0.94), all-cause mortality (RR, 0.91; 95%CI, 0.84–0.98), and intracranial hemorrhage (RR, 0.51; 95%CI, 0.38–0.70) compared with warfarin. Conclusions DOACs were more effective than warfarin, and at least as safe. Polypharmacy was associated with adverse outcomes and attenuated the advantage in risk of major bleeding among rivaroxaban users, particularly in the presence of P-glycoprotein/CYP3A4-modulating drugs.

scholarly journals Analysis of Influencing Factors of Compliance with Non-Vitamin K Antagonist Oral Anticoagulant in Patients with Nonvalvular Atrial Fibrillation and Correlation with the Severity of Ischemic Stroke

2021 ◽  
Vol 2021 ◽  
pp. 1-7
Author(s):  
Li Zhu ◽  
Xiaodan Zhang ◽  
Jing Yang
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Influencing Factors ◽  
Clinical Supervision ◽  
Vitamin K ◽  
Pearson Correlation ◽  
Anticoagulation Therapy ◽  
Vitamin K Antagonist ◽  
Nonvalvular Atrial Fibrillation ◽  
Increased Risk

Nonvalvular atrial fibrillation (NVAF) is associated with an increased risk of stroke and thrombus, and anticoagulant therapy is a key link in the prevention of stroke. At present, the anticoagulation rate of atrial fibrillation in China is low, and there are many factors affecting the adherence of patients with atrial fibrillation to anticoagulation. Non-vitamin K antagonist oral anticoagulants (NOACs) are anticoagulant with high application value due to their high safety and low risk of intracranial hemorrhage, stroke, and death. However, the compliance of NOACs is poor, and the current situation of anticoagulants in China is not optimistic. In this study, a total of 156 patients with NVAF who received NOAC anticoagulation therapy in our hospital from January 2018 to January 2019 were retrospectively analyzed. The results showed that education background, place of residence, number of complications, CHA2DS2-VASc score, and HAS-BLED score were independent influencing factors for NOACS compliance of NVAF patients. Also, the Pearson correlation analysis showed that there was a negative correlation (r = −0.465, P < 0.001 ) between NOAC compliance and severity of ischemic stroke in patients with NVAF. Therefore, clinical supervision and management of patients with NVAF after NOACs should be strengthened to improve the compliance of patients with NVAF after NOACs, reduce the damage of ischemic stroke, and improve their prognosis.

Long-term clinical outcomes after major bleeding in patients with atrial fibrillation: the Fushimi AF registry

2020 ◽  
Author(s):  
Hisashi Ogawa ◽  
Yoshimori An ◽  
Kenjiro Ishigami ◽  
Syuhei Ikeda ◽  
Kosuke Doi ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischaemic Stroke ◽  
Clinical Outcomes ◽  
Major Bleeding ◽  
Bleeding Event ◽  
Community Based ◽  
Increased Risk ◽  
All Cause Mortality

Abstract Aims Oral anticoagulants reduce the risk of ischaemic stroke but may increase the risk of major bleeding in atrial fibrillation (AF) patients. Little is known about the clinical outcomes of patients after a major bleeding event. This study assessed the outcomes of AF patients after major bleeding. Methods and results The Fushimi AF Registry is a community-based prospective survey of the AF patients in Fushimi-ku, Kyoto, Japan. Analyses were performed on 4304 AF patients registered by 81 institutions participating in the Fushimi AF Registry. We investigated the demographics and outcomes of AF patients who experienced major bleeding during follow-up period. During the median follow-up of 1307 days, major bleeding occurred in 297 patients (6.9%). Patients with major bleeding were older than those without (75.6 vs. 73.4 years; P &lt; 0.01). They were more likely to have pre-existing heart failure (33.7% vs. 26.7%; P &lt; 0.01), history of major bleeding (7.7% vs. 4.0%; P &lt; 0.01), and higher mean HAS-BLED score (2.05 vs.1.73; P &lt; 0.01). On landmark analysis, ischaemic stroke or systemic embolism occurred in 17 patients (3.6/100 person-years) after major bleeding and 227 patients (1.7/100 person-years) without major bleeding, with an adjusted hazard ratio (HR) of 1.93 [95% confidence interval (CI), 1.06–3.23; P = 0.03]. All-cause mortality occurred in 97 patients with major bleeding (20.0/100 person-years) and 709 (5.1/100 person-years) patients without major bleeding [HR 2.73 (95% CI, 2.16–3.41; P &lt; 0.01)]. Conclusion In this community-based cohort, major bleeding is associated with increased risk of subsequent all-cause mortality and thromboembolism in the long-term amongst AF patients. Trial registration https://www.umin.ac.jp/ctr/index.htm. Unique identifier: UMIN000005834. (last accessed 22 October 2020)

scholarly journals Rivaroxaban Versus Warfarin for Management of Obese African Americans With Non-Valvular Atrial Fibrillation or Venous Thromboembolism: A Retrospective Cohort Analysis

2020 ◽  
Vol 26 ◽  
pp. 107602962095491
Author(s):  
Olivia S. Costa ◽  
Jan Beyer-Westendorf ◽  
Veronica Ashton ◽  
Dejan Milentijevic ◽  
Kenneth Todd Moore ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Venous Thromboembolism ◽  
African Americans ◽  
Major Bleeding ◽  
Cox Regression ◽  
Cohort Analysis ◽  
Bleeding Risk ◽  
Nonvalvular Atrial Fibrillation ◽  
Thrombotic Risk ◽  
Hazard Ratios

African Americans (AAs) and obese individuals have increased thrombotic risk. This study evaluated the effectiveness and safety of rivaroxaban versus warfarin in obese, AAs with nonvalvular atrial fibrillation (NVAF) or venous thromboembolism (VTE). Optum® De-Identified Electronic Health Record (EHR) data was used to perform separate propensity-score matched analyses of adult, oral anticoagulant (OAC)-naïve AAs with NVAF or acute VTE, respectively; who had a body mass index≥30kg/m2 and ≥12-months EHR activity with ≥1-encounter before OAC initiation. Cox regression was performed and reported as hazard ratios (HRs) with 95% confidence intervals (CIs). For the NVAF analysis, 1,969 rivaroxaban- and 1,969 warfarin-users were matched. Rivaroxaban was not associated with a difference in stroke/systemic embolism versus warfarin (HR = 0.88, 95%CI = 0.60-1.28), but less major bleeding (HR = 0.68, 95%CI = 0.50-0.94) was observed. Among 683 rivaroxaban-users with VTE, 1:1 matched to warfarin-users, rivaroxaban did not alter recurrent VTE (HR = 1.36, 95%CI = 0.79-2.34) or major bleeding (HR = 0.80, 95%CI = 0.37-1.71) risk versus warfarin at 6-months (similar findings observed at 3- and 12-months). Rivaroxaban appeared to be associated with similar thrombotic, and similar or lower major bleeding risk versus warfarin in these obese, AA cohorts.

Risk Factors for Bleeding in Patients with Nonvalvular Atrial Fibrillation Who Are Receiving Anticoagulant Therapy with Ximelagatran or Warfarin: Findings from the SPORTIF III and V Trials.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 528-528
Author(s):  
James D. Douketis ◽  
Karin Arneklev ◽  
Samuel Goldhaber ◽  
John Spandorfer ◽  
Frank Halperin ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Risk Factors ◽  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Patient Population ◽  
Left Ventricular ◽  
Nonvalvular Atrial Fibrillation ◽  
Increased Risk ◽  
Risk For Bleeding ◽  
Statin Use

Abstract Background: Ximelagatran is a novel oral direct thrombin inhibitor that is as effective as warfarin in preventing stroke and other thromboembolic complications in patients with nonvalvular atrial fibrillation (AF). Risk factors for bleeding with warfarin are known, but risk factors for bleeding with ximelagatran have not been described. Unlike warfarin, ximelagatran has a predictable anticoagulant effect, does not require anticoagulation monitoring, has a low potential for interactions with drugs, food, or alcohol, and is not affected by genetic polymorphisms. We undertook an exploratory analysis of a large patient database to identify conventional and novel risk factors for bleeding in ximelagatran-treated patients, in warfarin-treated patients, and in all patients, irrespective of treatment. Methods: We undertook a pooled analysis of the SPORTIF III and V trials trials, which included 7329 patients with nonvalvular AF who received oral ximelagatran, 36 mg twice daily, or warfarin, administered to achieve a target international normalized ratio of 2.0–3.0. Patients had nonvalvular AF and 1 or more risk factors for stroke: hypertension; age ≥75 years; previous stroke, transient ischemic attack (TIA) or systemic embolism; left ventricular dysfunction; age ≥65 years and coronary artery disease; or age ≥65 years and diabetes mellitus. Major exclusion criteria were: mitral stenosis; previous heart valve surgery; transient AF; increased risk for bleeding. Multivariate logistic regression analysis was used to identify independent risk factors for major bleeding. The hazard ratio (HR) for major bleeding, and corresponding 95% confidence interval (CI), was calculated for each variable in the regression model. Results: The Table presents risk factors in which there was a significant or a non-significant (NS) association with major bleeding in ximelagatran-treated or warfarin-treated patients, and in the combined patient population. Risk factor Ximelagatran-treated patients, HR (95% CI) Warfarin-treated patients, HR (95% CI) Combined patient population, HR (95% CI) Aspirin use 1.65 (1.07, 2.55) 2.40 (1.69, 3.42) 1.96 (1.49, 2.58) Increasing age 1.03 (1.01, 1.05) 1.06 (1.03, 1.08) 1.04 (1.03, 1.06) Prior liver disease NS 4.96 (1.57, 15.62) NS Prior stroke or TIA 1.78 (1.16, 2.73) NS NS Diabetes mellitus 1.80 (1.18, 2.75) NS 1.39 (1.05, 1.86) Asian race NS NS 1.99 (1.16, 3.42) Statin use 0.62 (0.39, 0.97) 0.61 (0.42, 0.88) 0.62 (0.39, 0.97) Conclusions: Overall, the bleeding risk was lower with ximelagatran compared with warfarin. Aspirin use and increasing age were associated with an increased risk of bleeding in both ximelagatran- and warfarin-treated patients. Statin use was associated with a decreased risk for bleeding in both groups.

scholarly journals Comparative Safety and Effectiveness of Oral Anticoagulants in Nonvalvular Atrial Fibrillation

Stroke ◽  
2020 ◽  
Vol 51 (7) ◽  
pp. 2066-2075 ◽  
Author(s):  
Eric Van Ganse ◽  
Nicolas Danchin ◽  
Isabelle Mahé ◽  
Olivier Hanon ◽  
Flore Jacoud ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Oral Anticoagulant ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Large Population ◽  
National Health System ◽  
Nonvalvular Atrial Fibrillation ◽  
All Cause Mortality ◽  
Safety Effectiveness

Background and Purpose: The effects of direct oral anticoagulants in nonvalvular atrial fibrillation should be assessed in actual conditions of use. France has near-universal healthcare coverage with a unified healthcare information system, allowing large population-based analyses. NAXOS (Evaluation of Apixaban in Stroke and Systemic Embolism Prevention in Patients With Nonvalvular Atrial Fibrillation) aimed to compare the safety, effectiveness, and mortality of apixaban with vitamin K antagonists (VKAs), rivaroxaban, and dabigatran, in oral anticoagulant-naive patients with nonvalvular atrial fibrillation. Methods: This was an observational study using French National Health System claims data and including all adults with nonvalvular atrial fibrillation who initiated oral anticoagulant between 2014 and 2016. Outcomes of interest were major bleeding events leading to hospitalization (safety), stroke and systemic thromboembolic events (effectiveness), and all-cause mortality. Four approaches were used for comparative analyses: matching on propensity score (PS; 1:n); as a sensitivity analysis, matching on high-dimensional PS; adjustment on PS; and adjustment on known confounders. For each outcome, cumulative incidence rates accounting for competing risks of death were estimated. Results: Overall, 321 501 patients were analyzed, of whom 35.0%, 27.2%, 31.1%, and 6.6% initiated VKAs, apixaban, rivaroxaban, and dabigatran, respectively. Apixaban was associated with a lower PS–matched risk of major bleeding compared with VKAs (hazard ratio [HR], 0.43 [95% CI, 0.40–0.46]) and rivaroxaban (HR, 0.67 [95% CI, 0.63–0.72]), but not dabigatran (HR, 0.93 [95% CI, 0.81–1.08]). Apixaban was associated with a lower risk of stroke and systemic thromboembolic event compared with VKAs (HR, 0.60 [95% CI, 0.56–0.65]), but not rivaroxaban (HR, 1.05 [95% CI, 0.97–1.15]) or dabigatran (HR, 0.93 [95% CI, 0.78–1.11]). All-cause mortality was lower with apixaban than with VKAs, but not lower than with rivaroxaban or dabigatran. Conclusions: Apixaban was associated with superior safety, effectiveness, and lower mortality than VKAs; with superior safety than rivaroxaban and similar safety to dabigatran; and with similar effectiveness when compared with rivaroxaban or dabigatran. These observational data suggest potentially important differences in outcomes between direct oral anticoagulants, which should be explored in randomized trials.

scholarly journals Predictors for major bleeding in elderly (75 years and over) patients with non-valvular atrial fibrillation at high risk of bleeding: sub-analysis of the ANAFIE Registry

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
K Okumura ◽  
Keyword(s):  
Atrial Fibrillation ◽  
High Risk ◽  
Major Bleeding ◽  
Risk Group ◽  
Reference Group ◽  
Bleeding Risk ◽  
High Risk Group ◽  
Bleeding Events ◽  
All Cause Mortality ◽  
High Bleeding Risk

Abstract Background In patients with atrial fibrillation (AF) receiving anticoagulant therapy, bleeding events are associated with reduced survival. Previous studies showed that bleeding events during anticoagulant therapy were more frequent in elderly AF patients than in younger patients. HAS-BLED score has been used to assess the risk of bleeding in AF patients. In patients at high bleeding risk (HAS-BLED score ≥3), we sought to identify other risk factors associated with major bleeding not included in HAS-BLED score in elderly non-valvular AF (NVAF) patients. Purpose The All Nippon Atrial Fibrillation In the Elderly (ANAFIE) Registry is a prospective, multicenter, observational study to collect real-world data on clinical status and prognosis in more than 30,000 Japanese patients (aged ≥75 y) with NVAF. This sub-analysis of the ANAFIE Registry assessed the 2-year outcomes and identified predictors for major bleeding in elderly NVAF patients with a high bleeding risk. Methods A total of 32,275 patients from the ANAFIE Registry were divided into 2 groups according to HAS-BLED score (≥3 [high-risk group] and ≤2 [reference group]). The annualized incidence rate, hazard ratio (HR) for clinical outcomes, and independent predictors for major bleeding were analyzed using Kaplan-Meier analysis and the Cox proportional-hazards model. Results A total of 6,826 patients constituted the high-risk group: mean age, 81.8 years old (75–80 years, 37.8%; 81–84 years, 33.9%; ≥85 years, 28.3%); male ratio, 72.2%; mean creatinine clearance (CrCL), 42.7 mL/min; history of major bleeding, 14.2%; presence of non-paroxysmal AF, 62.2%; mean total number of medicines used, 7.8. Anticoagulants were used in 91.2% (warfarin [WF], 29.9%; direct oral anticoagulants [DOACs], 61.2%). Proton-pump inhibitors (PPI) were administered in 46.5%. Compared to the reference group, the high-risk group had higher annualized incidence rates (/100 patient-year) of major bleeding (1.49 vs 0.97), intracranial hemorrhage (0.95 vs 0.70), gastrointestinal (GI) bleeding (2.63 vs 1.73), and all-cause mortality (5.50 vs 3.24). All-cause mortality more frequently occurred in patients aged ≥85 years compared to 75–79 years and those with CrCL &lt;50 mL/min compared to CrCL ≥50 mL/min. In the high-risk group, DOAC subgroup had lower incidences of the above-mentioned outcomes other than GI bleeding than WF subgroup. The following relevant factors for major bleeding not included in HAS-BLED score were identified in the high-risk group: Body mass index (BMI) ≥25.0 kg/m2 (HR, 0.40), heart failure (HF) with reduced left ventricular ejection fraction (LVEF) (HR, 1.38), a fall within 1 year (HR, 2.29), and use of PPI (HR, 0.65). Conclusions Among elderly (≥75 years) Japanese NVAF patients in the high bleeding risk group (HAS-BLED score ≥3), HF with reduced LVEF, and a fall within 1 year were identified as independent predictors of major bleeding. BMI ≥25.0 kg/m2 and PPI use were protective for major bleeding. FUNDunding Acknowledgement Type of funding sources: Private company. Main funding source(s): Daiichi Sankyo Co., Ltd.

Abstract 159: Evaluation of Clinical Outcomes among Nonvalvular Atrial Fibrillation Patients Treated With Warfarin or Rivaroxaban Stratified by Presence or Absence of CKD in a Claims Database

2017 ◽  
Vol 10 (suppl_3) ◽  
Author(s):  
Matthew R Weir ◽  
Lloyd Haskell ◽  
Jeffrey S Berger ◽  
Veronica Ashton ◽  
François Laliberté ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Major Bleeding ◽  
Bleeding Event ◽  
Data Availability ◽  
Thromboembolic Events ◽  
Bleeding Events ◽  
Nonvalvular Atrial Fibrillation ◽  
Claims Database ◽  
Increased Risk

Introduction: Renal functional impairment is linked to an increased risk of thromboembolic and bleeding events in patients with nonvalvular atrial fibrillation (NVAF) treated with warfarin and rivaroxaban. Anticoagulants such as warfarin and rivaroxaban are often recommended to reduce the risk of stroke in NVAF patients. The purpose of this study was to evaluate and compare thromboembolic and bleeding event rates for warfarin and rivaroxaban patients stratified by presence of chronic kidney disease (CKD). Methods: Claims from the IMS Health Real-World Data Adjudicated Claims database from 05/2011-6/2015 were analyzed. Adult patients with NVAF who had ≥6 months of baseline data prior to the first dispensing of warfarin or rivaroxaban after 11/2011 were included. Patients were followed until the end of index therapy or end of data availability/insurance coverage. Outcomes were stratified by presence of CKD for ischemic stroke, major bleeding, and a composite measure of thromboembolic events (ischemic stroke, myocardial infarction (MI) or venous thromboembolism (VTE)) and analyzed using hazard ratios (HRs). Adjustments for confounding were made with inverse probability of treatment weights (IPTW). Results: The analysis included 39,872 rivaroxaban (9.0% [3,572 of 39,872] with CKD) and 48,637 warfarin patients (16.9% [8,230 of 48,637] with CKD). As expected, thromboembolic and bleeding events were more common in patients with CKD than those without CKD. Rivaroxaban patients had significantly lower risk of ischemic stroke, both in the overall population (HR = 0.79 [0.68-0.90], p=0.0008) and for those with CKD (HR = 0.55 [0.40-0.77], p=0.0004). A composite of thromboembolic events were lower with rivaroxaban irrespective of CKD. Major bleeding rates were comparable across all groups. Table 1 reports incidence rates and HRs stratified by presence of CKD. Conclusions: This study suggests that, in an adult population with NVAF, rivaroxaban-treated patients had fewer ischemic strokes across all patients, including patients with renal impairment. Rivaroxaban-treated patients also had significantly better outcomes for the composite (VTE, MI, or stroke) measure across all groups. Bleeding rates were comparable across all groups.

P4758Label adherence of non-vitamin K antagonist oral anticoagulants and clinical outcomes in patients with atrial fibrillation: A nationwide study

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
H T Yu ◽  
P S Yang ◽  
E Jang ◽  
T H Kim ◽  
J S Uhm ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Practice ◽  
Clinical Outcomes ◽  
Vitamin K ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Vitamin K Antagonist ◽  
Systemic Embolism ◽  
Increased Risk ◽  
All Cause Mortality

Abstract Background Dose adjustment of non-vitamin K antagonist oral anticoagulants (NOACs) is indicated in some patients with atrial fibrillation (AF), based on selected patient factors or concomitant medications. Purpose We assessed the frequency of label adherence of NOAC dosing among AF patients and the associations between off-label NOAC dosing and clinical outcomes in real-world clinical practice. Methods We evaluated 53,649 AF patients treated with a NOAC using Korean National Health Insurance Service database during the period from January 2013 to December 2016. NOAC doses were classified as either underdosed or overdosed, consistent with U.S. Food and Drug Administration labeling. Cox proportional hazards regression was performed to investigate the effectiveness and safety outcomes including stroke or systemic embolism, major bleeding, and all-cause mortality. Results Overall, 16,757 NOAC-treated patients (31.2%) were underdosed, 4,492 were overdosed (8.4%), and 32,400 (60.4%) were dosed appropriately according to drug labeling. Compared with patients with label adherence, those who were underdosed or overdosed were older (71±8 and 75±7 years of age vs. 70±9 years of age, respectively; p<0.001), more likely female (39% and 53% vs. 38%, respectively; p<0.001), and had higher CHA2DS2-VASc scores (4.6±1.7 and 5.3±1.7 vs. 4.5±1.8, respectively; p<0.001). NOAC overdosing was associated with increased risk for stroke or systemic embolism (5.76 vs. 4.03 events/100 patient-years, p<0.001), major bleeding (4.77 vs. 2.94 events/100 patient-years, p<0.001), and all-cause mortality (5.43 vs. 3.05 events/100 patient-years, p<0.001) compared with label-adherent use. Figure 1 Conclusion In routine clinical practice, a significant proportion (almost 2 in 5) of AF patients received NOAC doses inconsistent with drug labeling. NOAC overdosing is associated with increased risk for stroke or systemic embolism, major bleeding, and all-cause mortality in Asian patient with AF.

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