scholarly journals Impact of Reduced-Dose Nonvitamin K Antagonist Oral Anticoagulants on Outcomes Compared to Warfarin in Korean Patients with Atrial Fibrillation: A Nationwide Population-Based Study

2021 ◽  
Vol 10 (17) ◽  
pp. 3918
Author(s):  
Sola Han ◽  
Young-Hoon Kim ◽  
Myung-Yong Lee ◽  
Oh Young Bang ◽  
Sung-Won Jang ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Lower Risk ◽  
Oral Anticoagulants ◽  
Population Based ◽  
Systemic Embolism ◽  
Nonvalvular Atrial Fibrillation ◽  
Population Based Study ◽  
Reduced Dose ◽  
Asian Patients ◽  
Hazard Ratios

Reduced-dose nonvitamin K antagonist oral anticoagulants (NOACs) are commonly prescribed to Asian patients with nonvalvular atrial fibrillation (NVAF). We aimed to compare the risk of stroke/systemic embolism (S/SE) and major bleeding (MB) between patients treated with reduced-dose NOACs and those treated with warfarin, using the claims database in Korea. Patients with NVAF newly initiated on oral anticoagulants (OACs; apixaban, dabigatran, rivaroxaban, and warfarin) between 1 July 2015 and 30 November 2016 were included. Among all patients with NVAF treated with OACs, 5249, 6033, 7602, and 8648 patients were treated with reduced-dose apixaban, dabigatran, rivaroxaban, and warfarin, respectively. Patients treated with reduced-dose NOACs were older and had higher CHA2DS2-VASc and HAS-BLED scores than those treated with warfarin. Compared to warfarin, all reduced-dose NOACs showed significantly lower risk of S/SE (hazard ratios (95% confidence interval), 0.63 (0.52–0.75) for apixaban; 0.51 (0.42–0.61) for dabigatran; and 0.67 (0.57–0.79) for rivaroxaban) and MB (0.54 (0.45–0.65) for apixaban; 0.58 (0.49–0.69) for dabigatran; 0.73 (0.63–0.85) for rivaroxaban). In the real-world practice among Asians with NVAF, all reduced-dose NOACs were associated with a significantly lower risk of S/SE and MB compared to those of warfarin.

scholarly journals Direct Oral Anticoagulants in Atrial Fibrillation Patients With Concomitant Hyperthyroidism

2020 ◽  
Vol 105 (9) ◽  
pp. 2893-2904
Author(s):  
Yi-Hsin Chan ◽  
Lung-Sheng Wu ◽  
Lai-Chu See ◽  
Jia-Rou Liu ◽  
Shang-Hung Chang ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Lower Risk ◽  
Randomized Clinical Trials ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Study Groups ◽  
Research Database ◽  
Nonvalvular Atrial Fibrillation ◽  
Asian Patients

Abstract Objective Patients with hyperthyroidism were excluded from the randomized clinical trials of direct oral anticoagulants (DOACs) for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF). Methods We performed a nationwide retrospective cohort study using data from the Taiwan National Health Insurance Research Database. We enrolled 3213 and 1181 NVAF patients with hyperthyroidism who were taking DOACs and warfarin, respectively, from June 1, 2012 to December 31, 2017. We also enrolled 53 591 and 16 564 NVAF patients without hyperthyroidism, taking DOACs and warfarin, respectively. We used propensity score stabilized weights (PSSWs) to balance covariates across the study groups. We also used 1:4 matching on both taking DOACs, with (n = 3213) and without hyperthyroidism (n = 12 852); and both taking warfarin, with (n = 1181) and without hyperthyroidism (n = 4724). Results After PSSW, DOAC had a comparable risk of ischemic stroke/systemic embolism (IS/SE) and a lower risk of major bleeding (hazard ratio [HR] 0.65; 95% confidential interval [CI], 0.44–0.96; P = 0.0295) than warfarin among patients with hyperthyroidism. There were comparable risks of IS/SE and major bleeding between those patients with and without hyperthyroidism. However, among patients taking warfarin, those with hyperthyroidism had a lower risk of IS/SE than those without hyperthyroidism (HR 0.61; 95% CI, 0.43–0.86; P = 0.0050). Conclusion Among NVAF Asian patients with concomitant hyperthyroidism, DOACs may be an effective and safer alternative to warfarin. Thromboprophylaxis with DOACs may be considered for such patients, and it is important to validate this finding in further prospective study.

scholarly journals Comparison of dabigatran, rivaroxaban, and apixaban for effectiveness and safety in atrial fibrillation: a nationwide cohort study

2020 ◽  
Vol 6 (2) ◽  
pp. 75-85 ◽  
Author(s):  
Ole-Christian W Rutherford ◽  
Christian Jonasson ◽  
Waleed Ghanima ◽  
Fabian Söderdahl ◽  
Sigrun Halvorsen
Keyword(s):  
Atrial Fibrillation ◽  
Cohort Study ◽  
Major Bleeding ◽  
Lower Risk ◽  
Oral Anticoagulants ◽  
Vitamin K Antagonist ◽  
Routine Clinical Practice ◽  
Systemic Embolism ◽  
Nationwide Study ◽  
Hazard Ratios

Abstract Aims The aim of this study was to compare the risk of stroke or systemic embolism (SE) and major bleeding in patients with atrial fibrillation (AF) using dabigatran, rivaroxaban, and apixaban in routine clinical practice. Methods and results Using nationwide registries in Norway from January 2013 to December 2017, we established a cohort of 52 476 new users of non-vitamin K antagonist oral anticoagulants (NOACs) with AF. Users of individual NOACs were matched 1:1 on the propensity score to create three pairwise-matched cohorts: dabigatran vs. rivaroxaban (20 504 patients), dabigatran vs. apixaban (20 826 patients), and rivaroxaban vs. apixaban (27 398 patients). Hazard ratios (HRs) for the risk of stroke or SE and major bleeding were estimated. In the propensity-matched comparisons of the risk of stroke or SE, the HRs were 0.88 [95% confidence interval (CI) 0.76–1.02] for dabigatran vs. rivaroxaban, 0.88 (95% CI 0.75–1.02) for dabigatran vs. apixaban, and 1.00 (95% CI 0.89–1.14) for apixaban vs. rivaroxaban. For the risk of major bleeding, the HRs were 0.75 (95% CI 0.64–0.88) for dabigatran vs. rivaroxaban, 1.03 (95% CI 0.85–1.24) for dabigatran vs. apixaban, and 0.79 (95% CI 0.68–0.91) for apixaban vs. rivaroxaban. Conclusion In this nationwide study of patients with AF in Norway, we found no statistically significant differences in risk of stroke or SE in propensity-matched comparisons between dabigatran, rivaroxaban, and apixaban. However, dabigatran and apixaban were both associated with significantly lower risk of major bleeding compared with rivaroxaban.

Age-dependent anticoagulant therapy for atrial fibrillation patients with intermediate risk of ischemic stroke: A nationwide population-based study

2020 ◽  
Author(s):  
Sun Young Choi ◽  
Moo Hyun Hyun Kim ◽  
Kwang Min Lee ◽  
Young-Rak Cho ◽  
Jong Sung Park ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Lower Risk ◽  
Oral Anticoagulants ◽  
Population Based ◽  
Intermediate Risk ◽  
Composite Outcome ◽  
Population Based Study ◽  
Age Dependent ◽  
Korean National Health Insurance

Background: Although older age is one of the most important risk factors for stroke in atrial fibrillation (AF), it is unclear whether an age threshold exists for which oral anticoagulants (OACs) are beneficial for intermediate-risk AF patients. We sought to investigate the age-dependency of OAC for ischemic stroke in intermediate-risk AF patients. Methods: We enrolled 34,701 AF patients (males with a CHA2DS2-VASc score of 1 and females with a CHA2DS2-VASc score of 2) using the Korean National Health Insurance Service database. The clinical endpoint was the occurrence of ischemic stroke and a composite outcome (ischemic stroke + major bleeding + all-cause death). Results: In AF patients aged ≥ 55 years, OAC therapy was associated with a lower risk of ischemic stroke compared with non-OAC treatment in males (55-59 years: HR 0.79, 95% CI 0.61-0.98, p = 0.038, 60-64 years: HR 0.78, 95% CI 0.61-0.96, p = 0.029, and 65-74 years: HR 0.66, 95% CI 0.49-0.84, p = 0.011) and females (55-59 years: HR 0.76, 95% CI 0.58-0.96, p = 0.027, 60-64 years: HR 0.73, 95% CI 0.55-0.93, p = 0.017, and 65-74 years: HR 0.69, 95% CI 0.51-0.87, p = 0.013). OAC was associated with a lower risk for the composite outcome compared to non-OAC for male and female patients aged ≥ 55 years. Conclusions: Age is an important determinant of ischemic stroke and composite outcome in intermediate-risk AF patients. The benefit of OAC therapy for these AF patients appears to have an age threshold (age ≥ 55 years).

scholarly journals Impacts of off-label dosing noacs on clinical outcomes in very elderly patients with atrial fibrillation

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
T Chao ◽  
Y.H Chan ◽  
G.Y.H Lip ◽  
S.A Chen
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Outcomes ◽  
Major Bleeding ◽  
Lower Risk ◽  
Oral Anticoagulants ◽  
Systemic Embolism ◽  
Very Elderly ◽  
Off Label ◽  
Funding Sources ◽  
Clinical Events

Abstract Background Studies about the comparisons of on-label and off-label dosing non-vitamin K antagonist oral anticoagulants (NOACs) regarding the risks of clinical outcomes among atrial fibrillation (AF) patients have been published. However, data among the very elderly AF patients were limited. In the present study, we aimed to investigate the impacts of inappropriate dosing of NOACs on clinical outcomes in AF patients aged ≥85 years of age. Methods We used medical data from a multi-center healthcare system in Taiwan enrolling 1,836 and 268 AF patients aged ≥85 years treated with NOACs and warfarin, respectively. Among 1,836 patients receiving NOACs, underdosing, overdosing and on-label dosing NOACs were prescribed in 248, 149 and 1439 patients, respectively. The risks of ischemic stroke/systemic embolism (IS/SE) and major bleeding were compared between warfarin and NOACs in different dosing groups. Also, the risks of clinical events of underdosing and overdosing NOACs were comapred to on-labeling dosing. Results Compared to warfarin, underdosing NOACs were associated with a higher risk of IS/SE (aHR 2.39; p=0.048) without a lower risk of major bleeding; while overdosing NOACs were not associated with a lower risk of IS/SE (aHR 0.74, p=0.604) (Figure 1). Compared to on-label dosing NOACs, underdosing NOACs were associated with a higher risk of IS/SE, while the risk was not lower for overdoing NOACs (Figure 2). Conclusions Even for very elderly AF patients aged ≥85 years, NOACs should still be prescribed at the dosing following the criteria defined in clinical trials and guideline recommendations. FUNDunding Acknowledgement Type of funding sources: None. Figure 1 Figure 2

P4794Comparative effectiveness and safety of non-VKA oral anticoagulants versus warfarin in non-valvular atrial fibrillation patients with differential treatment duration: an ARISTOPHANES study analysis

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S Deitelzweig ◽  
A Keshishian ◽  
A Kang ◽  
A Dhamane ◽  
X Luo ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Lower Risk ◽  
Treatment Duration ◽  
Oral Anticoagulants ◽  
Pooled Analysis ◽  
Incidence Rates ◽  
Duration Of Treatment ◽  
Cox Models ◽  
Hazard Ratios

Abstract Background The ARISTOPHANES (Anticoagulants for Reduction In STroke: Observational Pooled analysis on Health outcomes ANd Experience of patientS) study showed that non-vitamin K antagonist oral anticoagulants (NOACs) were associated with lower risks of stroke/systemic embolism (S/SE) and variable comparative risks of major bleeding (MB) versus warfarin. Purpose To assess long-term use of non-VKA oral anticoagulants (NOACs) vs. warfarin in ARISTOPHANES by evaluating the risk of S/SE and MB among non-valvular atrial fibrillation (NVAF) patients by duration of treatment (<1 and ≥1 year). Methods In the ARISTOPHANES study, NVAF patients initiating apixaban, dabigatran, rivaroxaban, or warfarin from 01/01/2013–09/30/2015 were identified from the CMS Medicare data and four US commercial claims databases, covering >180 million beneficiaries annually (∼56% of US population). After 1:1 propensity score matching (PSM) in each database between NOACs and warfarin (apixaban-warfarin, dabigatran-warfarin, and rivaroxaban-warfarin), the resulting patient records were pooled. Treatment duration was defined as time between the day after the treatment index date and discontinuation (30 days after a 30-day gap in the prescription), treatment switch, death, end of study period, or end of continuous medical and pharmacy enrollment, whichever occurred first. Matched patients with observed treatment duration <1 or ≥1 year were separately examined. Cox models were used to estimate hazard ratios of S/SE and MB (identified by inpatient claims) during observed treatment duration. Results The mean treatment duration for patients with shorter (<1 year) vs longer (≥1 year) duration was 4–5 months vs 18–21 months across the three matched cohorts. All the matched baseline variables remained balanced. The incidence rates of S/SE and MB and the proportion of patients with treatment discontinuation were higher in patients with shorter treatment duration. Regardless of treatment duration, apixaban patients had a lower risk of S/SE and MB versus warfarin; dabigatran patients had a lower risk of MB versus warfarin; and rivaroxaban patients had a lower risk of S/SE versus warfarin. Compared to warfarin patients, dabigatran patients with treatment duration <1 year had a similar risk of S/SE, while those with treatment duration ≥1 year had lower S/SE risk; rivaroxaban patients with treatment duration <1 year had a higher risk of MB, while those with treatment duration ≥1 year had similar MB risk. Conclusions Among NVAF patients with duration of treatment <1 and ≥1 year in the ARISTOPHANES study, apixaban and rivaroxaban were associated with lower risk of S/SE, while apixaban and dabigatran were associated with lower risk of MB, compared to warfarin. These findings indicate varying long-term effectiveness and safety outcomes between NOACs and warfarin. Acknowledgement/Funding This study was funded by Bristol-Myers Squibb and Pfizer Inc.

scholarly journals Risk of Ischemic Stroke in Patients With Non-Valvular Atrial Fibrillation Not Receiving Oral Anticoagulants　― Korean Nationwide Population-Based Study ―

2017 ◽  
Vol 81 (8) ◽  
pp. 1158-1164 ◽  
Author(s):  
Si-Hyuck Kang ◽  
Eue-Keun Choi ◽  
Kyung-Do Han ◽  
So-Ryoung Lee ◽  
Woo-Hyun Lim ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Oral Anticoagulants ◽  
Population Based ◽  
Population Based Study

Effectiveness and Safety of Non–Vitamin K Oral Anticoagulants in Comparison to Phenprocoumon: Data from 61,000 Patients with Atrial Fibrillation

2018 ◽  
Vol 118 (03) ◽  
pp. 526-538 ◽  
Author(s):  
Stefan Hohnloser ◽  
Edin Basic ◽  
Christopher Hohmann ◽  
Michael Nabauer
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Standard Dose ◽  
Oral Anticoagulants ◽  
Proportional Hazard ◽  
Systemic Embolism ◽  
Cox Proportional Hazard ◽  
Hazard Ratios ◽  
Cox Proportional Hazard Models ◽  
Baseline Characteristics

AbstractAll pivotal trials have evaluated non–vitamin K oral antagonists (NOACs) against warfarin. However, in some regions of the world, phenprocoumon is the most widely used vitamin K antagonist (VKA). There is little evidence documenting effectiveness and safety of NOACs compared with phenprocoumon in atrial fibrillation (AF). A retrospective cohort study using a German claims database was conducted to assess effectiveness (stroke, systemic embolism [SE]) and safety (bleeding leading to hospitalization) during therapy with NOACs and phenprocoumon in 61,205 AF patients. Hazard ratios (HRs) for effectiveness and safety outcomes were derived from Cox proportional hazard models, adjusting for baseline characteristics. Propensity score matching was performed as a sensitivity analysis. As a prespecified subgroup analysis, the effects of reduced NOAC dosing were compared with phenprocoumon. A total of 61,205 patients were identified in whom phenprocoumon (n = 23,823, 38.9%), apixaban (n = 10,117, 16.5%), dabigatran (n = 5,122, 8.4%), or rivaroxaban (n = 22,143, 36.2%) was initiated. After adjusting for baseline confounders, all three NOACs tested had significantly lower risks of stroke/SE compared with phenprocoumon (apixaban—HR: 0.77, 95% CI: 0.66–0.90; dabigatran—HR: 0.74, 95% CI: 0.60–0.91; rivaroxaban—HR: 0.86, 95% CI: 0.76–0.97). Apixaban (HR: 0.58, 95% CI: 0.49–0.69) and dabigatran (HR: 0.64, 95% CI: 0.50–0.80) were associated with lower bleeding risks than phenprocoumon, whereas the risk was similar for rivaroxaban and phenprocoumon. All three NOACs showed reduced risk of intracranial bleeding compared with phenprocoumon. Reduced doses of NOACs were predominantly used in patients with advanced age and comorbidities with generally similar effectiveness and safety benefits compared with phenprocumon as standard-dose NOACs.

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