scholarly journals Effectiveness, Safety, and Major Adverse Limb Events in Atrial Fibrillation Patients with Concomitant Diabetes Mellitus Treated with Non-Vitamin K Antagonist Oral Anticoagulants

2020 ◽  
Author(s):  
Yi-Hsin Chan ◽  
Hsin-Fu Lee ◽  
Pei-Ru Li ◽  
Jia-Rou Liu ◽  
Tze-Fan Chao ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Atrial Fibrillation ◽  
Vitamin K ◽  
Lower Risk ◽  
Oral Anticoagulants ◽  
Study Groups ◽  
Vitamin K Antagonist ◽  
Major Adverse Cardiovascular Events ◽  
Research Database ◽  
Atherosclerotic Burden

Abstract Background: Evidence of adverse clinical outcomes for non-vitamin K antagonist oral anticoagulant (NOACs) and warfarin in patients with atrial fibrillation (AF) and diabetes mellitus are limited. We investigated the effectiveness, safety, and major adverse limb events for NOACs versus warfarin among diabetic AF patients. Methods: In this nationwide retrospective cohort study collected from Taiwan National Health Insurance Research Database, we identified a total of 20,967 and 5,812 consecutive AF patients with diabetes taking NOACs and warfarin from June 1, 2012, to December 31, 2017, respectively. We used propensity-score stabilized weighting to balance covariates across study groups. Results: NOAC was associated with a lower risk of major adverse cardiovascular events (MACE) (adjusted hazard ratio (aHR):0.88; [95% confidential interval (CI):0.78-0.99]; P =0.0283), major adverse limb events (aHR:0.72;[95%CI:0.57-0.92]; P =0.0083), and major bleeding (aHR:0.67;[95%CI:0.59-0.76]; P <.0001) compared to warfarin. NOACs decreased MACE in patients of 75 but not in those aged <75 years ( P interaction=0.01), and in patients with ischemic heart disease (IHD) compared to those without IHD ( P interaction<0.01). For major adverse limb events, the advantage of risk reduction for NOAC over warfarin persisted in high risk subgroups including age 75 years, chronic kidney disease, IHD, peripheral artery disease, or use of concomitant antiplatelet drugs. Conclusion: NOACs were associated with a lower risk of effectiveness, safety, and major adverse limb events than warfarin among diabetic AF patients. Thromboprophylaxis with NOACs should be considered in the diabetic AF population with a high atherosclerotic burden.

scholarly journals Effectiveness, Safety, and Major Adverse Limb Events in Atrial Fibrillation Patients with Concomitant Diabetes Mellitus Treated with Non-Vitamin K Antagonist Oral Anticoagulants

2020 ◽  
Author(s):  
Yi-Hsin Chan ◽  
Hsin-Fu Lee ◽  
Pei-Ru Li ◽  
Jia-Rou Liu ◽  
Tze-Fan Chao ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Atrial Fibrillation ◽  
Vitamin K ◽  
Major Bleeding ◽  
Lower Risk ◽  
Oral Anticoagulants ◽  
Study Groups ◽  
Vitamin K Antagonist ◽  
Major Adverse Cardiovascular Events ◽  
Research Database

Abstract Background: Evidence of adverse clinical outcomes for non-vitamin K antagonist oral anticoagulant (NOACs) and warfarin in patients with atrial fibrillation (AF) and diabetes mellitus are limited. We investigated the effectiveness, safety, and major adverse limb events for NOACs versus warfarin among diabetic AF patients.Methods: In this nationwide retrospective cohort study collected from Taiwan National Health Insurance Research Database, we identified a total of 20,967 and 5,812 consecutive AF patients with diabetes taking NOACs and warfarin from June 1, 2012, to December 31, 2017, respectively. We used propensity-score stabilized weighting to balance covariates across study groups.Results: NOAC was associated with a lower risk of major adverse cardiovascular events (MACE) (adjusted hazard ratio (aHR):0.88; [95% confidential interval (CI):0.78-0.99]; P=0.0283), major adverse limb events (MALE) (aHR:0.72;[95%CI:0.57-0.92]; P=0.0083), and major bleeding (aHR:0.67;[95%CI:0.59-0.76];P<.0001) compared to warfarin. NOACs decreased MACE in patients of 75 but not in those aged <75 years (P interaction=0.01), and in patients with ischemic heart disease (IHD) compared to those without IHD (P interaction<0.01). For major adverse limb events, the advantage of risk reduction for NOAC over warfarin persisted in high risk subgroups including age 75 years, chronic kidney disease, IHD, peripheral artery disease, or use of concomitant antiplatelet drugs. Conclusion: Among diabetic AF patients, NOACs were associated with a lower risk of thromboembolism, major bleeding, and major adverse limb events than warfarin. Thromboprophylaxis with NOACs should be considered in the diabetic AF population with a high atherosclerotic burden.

scholarly journals Lower Risk of Dementia in Patients With Atrial Fibrillation Taking Non‐Vitamin K Antagonist Oral Anticoagulants: A Nationwide Population‐Based Cohort Study

2021 ◽  
Vol 10 (5) ◽  
Author(s):  
Jin‐Yi Hsu ◽  
Peter Pin‐Sung Liu ◽  
An‐Bang Liu ◽  
Shu‐Man Lin ◽  
Huei‐Kai Huang ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Cohort Study ◽  
Vitamin K ◽  
Lower Risk ◽  
Randomized Clinical Trials ◽  
Oral Anticoagulants ◽  
Population Based ◽  
Vitamin K Antagonist ◽  
Research Database ◽  
Incident Cases

Background A higher risk of developing dementia is observed in patients with atrial fibrillation (AF). Results are inconsistent regarding the risk of dementia when patients with AF use different anticoagulants. We aimed to investigate the risk of dementia in patients with AF receiving non‐vitamin K antagonist oral anticoagulants (NOACs) compared with those receiving warfarin. Methods and Results We conducted a nationwide population‐based cohort study of incident cases using the Taiwan National Health Insurance Research Database. We initially enlisted all incident cases of AF and then selected those treated with either NOACs or warfarin for at least 90 days between 2012 and 2016. First‐ever diagnosis of dementia was the primary outcome. We performed propensity score matching to minimize the difference between each cohort. We used the Fine and Gray competing risk regression model to calculate the hazard ratio (HR) for dementia. We recruited 12 068 patients with AF (6034 patients in each cohort). The mean follow‐up time was 3.27 and 3.08 years in the groups using NOACs and warfarin, respectively. Compared with the HR for the group using warfarin, the HR for dementia was 0.82 (95% CI, 0.73–0.92; P =0.0004) in the group using NOACs. Subgroup analysis demonstrated that users of NOAC aged 65 to 74 years, with a high risk of stroke or bleeding were associated with a lower risk of dementia than users of warfarin with similar characteristics. Conclusions Patients with AF using NOACs were associated with a lower risk of dementia than those using warfarin. Further randomized clinical trials are greatly needed to prove these findings.

P4793Comparing the effectiveness and safety of non-vitamin K antagonist oral anticoagulants and warfarin in the elderly Asian patients with atrial fibrillation

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
T F Chao ◽  
J N Liao ◽  
G Y H Lip ◽  
S A Chen
Keyword(s):  
Atrial Fibrillation ◽  
Adverse Events ◽  
Elderly Patients ◽  
Vitamin K ◽  
Stroke Prevention ◽  
Lower Risk ◽  
Oral Anticoagulants ◽  
The Elderly ◽  
Vitamin K Antagonist ◽  
Research Database

Abstract Background Stroke prevention in elderly patients with atrial fibrillation (AF) can be challenging. Comparisons of non-vitamin K antagonist oral anticoagulants (NOACs) and warfarin in the elderly, at different age strata (age 65–74, 75–89, ≥90) in the daily practice have not been well described, particularly in Asians. We aimed to assess the clinical outcomes of NOACs compared warfarin for stroke prevention in elderly patients with AF. Methods A total of 64,169 AF patients aged ≥65 years receiving NOACs or warfarin prescription were identified from the Taiwan National Health Insurance Research Database. The risks of adverse events were compared between NOACs and warfarin in all patients age ≥65 and specifically, with different age strata; that is 65–74 years, 75–89 years and >90 years. Results Overall NOACs were associated with a significantly lower risk of ischemic stroke (adjusted hazard ratio [aHR] 0.869, 95% confidence interval [CI] 0.812–0.931), ICH (aHR 0.524, 95% CI 0.456–0.601), major bleeding (aHR 0,824, 95% CI 0.776–0.875), mortality (aHR 0.511, 95% CI 0.491–0.532) and composite adverse events (aHR 0.646, 95% CI 0.625–0.667) compared to warfarin. There was heterogeneity in treatment effect for NOACs versus warfarin in different age strata, but the results still favored NOACs even among the very elderly (>90 years). The absolute risk difference and reductions in ICH and composite adverse events with NOAC use were even greater among the elderly compared to warfarin (Figure). Conclusions Compared to warfarin, NOACs were associated with a significantly lower risk of adverse events, with heterogeneity in treatment effects among different age strata. Overall, the clear safety signal in favor of NOACs over warfarin was evident irrespective of age strata, being most marked in the most elderly.

Non-vitamin K antagonist oral anticoagulants and warfarin in atrial fibrillation patients with concomitant peripheral artery disease

2019 ◽  
Author(s):  
Hsin-Fu Lee ◽  
Lai-Chu See ◽  
Pei-Ru Li ◽  
Jia-Rou Liu ◽  
Tze-Fan Chao ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischaemic Stroke ◽  
Vitamin K ◽  
Major Bleeding ◽  
Lower Limb ◽  
Lower Risk ◽  
Oral Anticoagulants ◽  
Vitamin K Antagonist ◽  
Peripheral Artery ◽  
Artery Disease

Abstract Aims  To investigate the effectiveness, safety, and outcomes of lower limb events for non-vitamin K antagonist oral anticoagulants (NOACs) vs. warfarin among atrial fibrillation (AF) patients with concomitant peripheral artery disease (PAD). Methods and results In this nationwide retrospective cohort study collected from Taiwan National Health Insurance Research Database, a total of 5768 and 2034 consecutive AF patients with PAD patients taking NOACs or warfarin were identified from 1 June 2012 to 31 December 2017, respectively. We used propensity score stabilized weighting to balance covariates across study groups. In the cohort, there were 89% patients were taking low-dose NOAC (dabigatran 110 mg twice daily, rivaroxaban 10–15 mg daily, apixaban 2.5 mg twice daily, or edoxaban 30 mg daily). Non-vitamin K antagonist oral anticoagulant was associated with a comparable risk of ischaemic stroke, and a lower risk of acute myocardial infarction [hazard ratio (HR): 0.61, 95% confidence interval (CI): 0.42–0.87; P = 0.007], lower extremity thromboembolism (HR: 0.56, 95% CI: 0.44–0.72; P &lt; 0.0001), revascularization procedure (HR: 0.58, 95% CI: 0.47–0.72; P &lt; 0.0001), lower limb amputation (HR: 0.32, 95% CI: 0.23–0.46; P &lt; 0.0001), and all major bleeding (HR: 0.64, 95% CI: 0.50–0.80; P = 0.0001) than warfarin after weighting. The advantage of NOACs over warfarin persisted in high-risk subgroups including patients of ≥75 years of age, diabetes, renal impairment, or use of concomitant antiplatelet agent. Conclusion  This population-based study indicated that NOACs were associated with a comparable risk of ischaemic stroke, and a significantly lower risk of major adverse limb events and major bleeding than warfarin among AF patients with concomitant PAD. Therefore, thromboprophylaxis with NOACs may be considered for such patients.

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 between non-vitamin K antagonist oral anticoagulants versus warfarin for the risk of dementia in Asian patients with non-valvular atrial fibrillation

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
S.R Lee ◽  
E.K Choi ◽  
S.H Park ◽  
K.D Han ◽  
S Oh ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Vascular Dementia ◽  
Vitamin K ◽  
Lower Risk ◽  
Oral Anticoagulants ◽  
Vitamin K Antagonist ◽  
Weighting Method ◽  
Alzheimer Dementia ◽  
Prior Stroke ◽  
Incidence Of Dementia

Abstract Background Atrial fibrillation (AF) is a risk factor for dementia and oral anticoagulant (OAC) use is associated with a decreased risk of dementia in patients with AF. Objective We sought to find whether the risk of dementia would be different between patients treated with non-vitamin K antagonist oral anticoagulants (NOACs) and those treated with warfarin. Methods Using the Korean National Health Insurance database from January 2014 to December 2017, we identified OAC naïve non-valvular AF patients aged 40 years or older. For the comparison, warfarin and NOAC groups were balanced using the inverse probability of treatment weighting method (IPTW). The primary outcome was incident dementia. Patients were censored at the occurrence of dementia, discontinuation of index treatment, or the end of the study period (December 31, 2018). Results Among 72,846 of total study patients, 25,948 were treated with warfarin and 46,898 were treated with NOAC (17,193 with rivaroxaban, 9,882 with dabigatran, 11,992 with apixaban, and 7,831 with edoxaban). Crude incidence of dementia was 4.65 per 100 person-years in warfarin group and 4.98 per 100 person years in NOAC group. Baseline characteristics were well-balanced after IPTW (mean age 72 years, 93% CHA2DS2-VASc ≥2, 58% men). Compared to warfarin, NOAC showed a comparable risk of dementia (hazard ratio [HR] 0.944, 95% confidence interval [CI] 0.934–1.059), vascular dementia (HR 0.921, 95% CI 0.814–1.043) and Alzheimer dementia (HR 1.101, 95% CI 1.019–1.191). When comparing individual NOACs with warfarin, edoxaban was associated with a lower risk of dementia (HR 0.830, 95% CI 0.740–0.931). Rivaroxaban (HR 0.767, 95% CI 0.648–0.907) and edoxaban (HR 0.786, 95% CI 0.620–0.996) were associated with a lower risk of vascular dementia than warfarin. In subgroup analyses, NOAC was associated with a lower incidence of dementia than warfarin particularly in patients with prior stroke (HR 0.891, 95% CI 0.820–0.968) and in patients aged 65–74 years (HR 0.815, 95% CI 0.709–0.936). Conclusion In this large Asian population with AF, NOAC showed a comparable result with warfarin on the risk of dementia. Edoxaban was associated with a lower risk of dementia. NOAC appeared more beneficial especially in those with AF who had a history of prior stroke and aged 65–74 years. Funding Acknowledgement Type of funding source: None

scholarly journals Effectiveness and safety of non-vitamin K antagonist oral anticoagulants among nonvalvular atrial fibrillation patients with prior bleeding events

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
G.Y.H Lip ◽  
A Keshishian ◽  
A Kang ◽  
X Luo ◽  
N Atreja ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Lower Risk ◽  
Oral Anticoagulants ◽  
Bleeding Event ◽  
Vitamin K Antagonist ◽  
Bleeding Events ◽  
History Of ◽  
The Impact ◽  
Index Treatment

Abstract Background Among non-valvular atrial fibrillation (NVAF) patients with a history of bleeding, there is a reluctance to use oral anticoagulants (OACs) due to concerns about the risk of bleeding associated with OACs. However, lack of OAC treatments for NVAF patients is associated with a higher risk of stroke and mortality. Non-vitamin K antagonist OAC (NOACs) have been approved for the prevention of stroke in NVAF patients. There are limited data comparing the risk of stroke/systemic embolism (S/SE) and major bleeding (MB) between patients prescribed NOACs and with a history of bleeding. Purpose This study used multiple United States data sources to evaluate the risk of S/SE and MB among NVAF patients with prior bleeding events who were prescribed NOACs. Methods This retrospective observational study used data from CMS Medicare and four commercial databases–covering &gt;180 million beneficiaries. The study selected adult NVAF patients who were prescribed apixaban, dabigatran, or rivaroxaban (01JAN2013–30JUN2019) and had a prior bleeding event which was defined as a hospitalization with a bleeding diagnosis (intracranial hemorrhage [ICH], gastrointestinal [GI] bleeding, or other bleeding sites) prior to or during the index treatment episode. After 1:1 propensity-score-matched (PSM) in each database between NOACs (apixaban-dabigatran, apixaban-rivaroxaban, and dabigatran-rivaroxaban), the resulting patient records were pooled. S/SE and MB (identified by inpatient claims) were captured during the follow-up period, which was defined as the time between the day after the index treatment date and treatment discontinuation or switch, death, end of study period, or end of medical and pharmacy enrollment. Hazard ratios of S/SE and MB were calculated using Cox proportional hazards models. Results Of the overall NVAF population treated with NOACs, 6.2% had a prior bleeding event (ICH: 13.5%; GI: 61.8%; Other: 24.6%). After PSM, a total of 11,106 apixaban-dabigatran, 30,665 apixaban-rivaroxaban, and 11,148 dabigatran-rivaroxaban pairs were matched. Apixaban was associated with a lower risk of S/SE compared to dabigatran and rivaroxaban, and dabigatran was associated with a similar risk of S/SE compared to rivaroxaban. Apixaban was associated with a lower risk of MB compared to dabigatran and rivaroxaban, and dabigatran was associated with a lower risk of MB compared to rivaroxaban (Figure). Conclusions In this subgroup of NVAF patients with a history of bleeding, apixaban was associated with a lower risk of S/SE and MB compared to dabigatran and rivaroxaban. Dabigatran was associated with a lower risk of MB compared to rivaroxaban. These results are informative for understanding the impact of NOAC treatment in NVAF patients with prior bleeding events. FUNDunding Acknowledgement Type of funding sources: Private company. Main funding source(s): Bristol-Myers Squibb Company and Pfizer, Inc.

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