Clinical profile of direct oral anticoagulants versus vitamin K anticoagulants in octogenarians with atrial fibrillation: a multicentre propensity score matched real-world cohort study

Objective: To describe major events at follow up in octogenarian patients with atrial fibrillation (AF) according to anticoagulant treatment: direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs). Methods: A total of 578 anticoagulated patients aged ≥80 years with AF were included in a prospective, observational, multicenter study. Basal features, embolic events (stroke and systemic embolism), severe bleedings, and all-cause mortality at follow up were investigated according to the anticoagulant treatment received. Results: Mean age was 84.0 ± 3.4 years, 56% were women. Direct oral anticoagulants were prescribed to 123 (21.3%) patients. Compared with 455 (78.7%) patients treated with VKAs, those treated with DOACs presented a lower frequency of permanent AF (52.9% vs 61.6%, P = .01), cancer history (4.9% vs 10.9%, P = .046), renal failure (21.1% vs 32.2%, P = .02), and left ventricular dysfunction (2.4% vs 8.0%, P = .03); and higher frequency of previous stroke (26.0% vs 16.6%, P = .02) and previous major bleeding (8.1% vs 3.6%, P = .03). There were no significant differences in Charlson, CHA2DS2VASc, nor HAS-BLED scores. At 3-year follow up, rates of embolic events, severe bleedings, and all-cause death (per 100 patients-year) were similar in both groups (DOACs vs VKAs): 0.34 vs 1.35 ( P = .15), 3.45 vs 4.41 ( P = .48), and 8.2 vs 11.0 ( P = .18), respectively, without significant differences after multivariate analysis (hazard ratio [HR]: 0.25, 95% confidence interval [CI]: 0.03-1.93, P = .19; HR: 0.88, 95% CI: 0.44-1.76, P = .72 and HR: 0.84, 95% CI: 0.53-1.33, P = .46, respectively). Conclusion: In this “real-world” registry, the differences in major events rates in octogenarians with AF were not statistically significant in those treated with DOACs versus VKAs.

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Bleeding risk with rivaroxaban compared with vitamin K antagonists in patients aged 80 years or older with atrial fibrillation

Heart ◽

10.1136/heartjnl-2020-317923 ◽

2020 ◽

pp. heartjnl-2020-317923 ◽

Cited By ~ 1

Author(s):

Olivier Hanon ◽

Jean-Sébastien Vidal ◽

George Pisica-Donose ◽

Galdric Orvoën ◽

Jean-Philippe David ◽

...

Keyword(s):

Atrial Fibrillation ◽

Propensity Score ◽

Vitamin K ◽

Lower Risk ◽

Vitamin K Antagonists ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Bleeding Risk ◽

Matched Sample ◽

Intracerebral Bleeding

ObjectiveDirect oral anticoagulants have been evaluated in the general population, but proper evidence for their safe use in the geriatric population is still missing. We compared the bleeding risk of a direct oral anticoagulant (rivaroxaban) and vitamin K antagonists (VKAs) among French geriatric patients with non-valvular atrial fibrillation (AF) aged ≥80 years.MethodsWe performed a sequential observational prospective cohort study, using data from 33 geriatric centres. The sample comprised 908 patients newly initiated on VKAs between September 2011 and September 2014 and 995 patients newly initiated on rivaroxaban between September 2014 and September 2017. Patients were followed up for up to 12 months. One-year risks of major, intracerebral, gastrointestinal bleedings, ischaemic stroke and all-cause mortality were compared between rivaroxaban-treated and VKA-treated patients with propensity score matching and Cox models.ResultsMajor bleeding risk was significantly lower in rivaroxaban-treated patients (7.4/100 patient-years) compared with VKA-treated patients (14.6/100 patient-years) after multivariate adjustment (HR 0.66; 95% CI 0.43 to 0.99) and in the propensity score–matched sample (HR 0.53; 95% CI 0.33 to 0.85). Intracerebral bleeding occurred less frequently in rivaroxaban-treated patients (1.3/100 patient-years) than in VKA-treated patients (4.0/100 patient-years), adjusted HR 0.59 (95% CI 0.24 to 1.44) and in the propensity score–matched sample HR 0.26 (95% CI 0.09 to 0.80). Major lower bleeding risk was largely driven by lower risk of intracerebral bleeding.ConclusionsOur study findings indicate that bleeding risk, largely driven by lower risk of intracerebral bleeding, is lower with rivaroxaban than with VKA in stroke prevention in patients ≥80 years old with non-valvular AF.

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Direct oral anticoagulants versus vitamin K antagonists in real-world patients with nonvalvular atrial fibrillation. The FANTASIIA study

Revista Española de Cardiología (English Edition) ◽

10.1016/j.rec.2019.02.021 ◽

2020 ◽

Vol 73 (1) ◽

pp. 14-20

Author(s):

Manuel Anguita Sánchez ◽

Vicente Bertomeu Martínez ◽

Martín Ruiz Ortiz ◽

Ángel Cequier Fillat ◽

Inmaculada Roldán Rabadán ◽

...

Keyword(s):

Atrial Fibrillation ◽

Vitamin K ◽

Real World ◽

Vitamin K Antagonists ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Nonvalvular Atrial Fibrillation

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Comparative effectiveness and safety of direct oral anticoagulants versus vitamin K antagonists in nonvalvular atrial fibrillation: a Canadian multicentre observational cohort study

CMAJ Open ◽

10.9778/cmajo.20200055 ◽

2020 ◽

Vol 8 (4) ◽

pp. E877-E886

Author(s):

Madeleine Durand ◽

Mireille E. Schnitzer ◽

Menglan Pang ◽

Greg Carney ◽

Sherif Eltonsy ◽

...

Keyword(s):

Atrial Fibrillation ◽

Cohort Study ◽

Vitamin K ◽

Comparative Effectiveness ◽

Vitamin K Antagonists ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Observational Cohort Study ◽

Nonvalvular Atrial Fibrillation ◽

Observational Cohort

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Fracture risks among patients with atrial fibrillation receiving different oral anticoagulants: a real-world nationwide cohort study

European Heart Journal ◽

10.1093/eurheartj/ehz952 ◽

2020 ◽

Vol 41 (10) ◽

pp. 1100-1108 ◽

Cited By ~ 13

Author(s):

Huei-Kai Huang ◽

Peter Pin-Sung Liu ◽

Jin-Yi Hsu ◽

Shu-Man Lin ◽

Carol Chiung-Hui Peng ◽

...

Keyword(s):

Atrial Fibrillation ◽

Cohort Study ◽

Propensity Score ◽

Fracture Risk ◽

Propensity Score Matching ◽

Real World ◽

Cox Regression ◽

Oral Anticoagulants ◽

Research Database ◽

Cox Regression Analysis

Abstract Aims To evaluate the fracture risk among patients with atrial fibrillation (AF) treated with non-vitamin K antagonist oral anticoagulants (NOACs) or warfarin. Methods and results We conducted a real-world nationwide retrospective cohort study using Taiwan’s National Health Insurance Research Database. All adult patients in Taiwan newly diagnosed with AF between 2012 and 2016 who received NOACs or warfarin were enrolled and followed up until 2017. Patients treated with NOACs were sub-grouped according to the NOAC used (dabigatran, rivaroxaban, and apixaban). Propensity score matching was performed for each head-to-head comparison. Cox regression analysis, with a shared frailty model, was used to calculate the adjusted hazard ratios (aHRs) for hip, vertebral, and humerus/forearm/wrist fractures. After matching, 19 414 patients were included (9707 in each NOAC and warfarin groups). The median follow-up time was 2.4 years. Compared with warfarin, NOACs were associated with a reduced fracture risk [aHR = 0.84, 95% confidence interval (CI) = 0.77–0.93; P < 0.001]. Sub-analyses revealed that each NOAC, namely dabigatran (aHR = 0.88, 95% CI = 0.78–0.99; P = 0.027), rivaroxaban (aHR = 0.81, 95% CI = 0.72–0.90; P < 0.001), and apixaban (aHR = 0.67, 95% CI = 0.52–0.87; P = 0.003), had a reduced fracture risk. Analyses including all eligible patients, without propensity score matching, generated similar results. Conclusion Compared with warfarin, NOAC was associated with a reduced fracture risk among AF patients. Therefore, if oral anticoagulants are indicated, NOACs rather than warfarin should be considered to lower the risk of fractures. However, further studies are needed to investigate the underlying mechanisms and elucidate causality.

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Clinical Outcome of Edoxaban vs. Vitamin K Antagonists in Patients with Atrial Fibrillation and Diabetes Mellitus: Results from a Multicenter, Propensity-Matched, Real-World Cohort Study

Journal of Clinical Medicine ◽

10.3390/jcm9061621 ◽

2020 ◽

Vol 9 (6) ◽

pp. 1621 ◽

Cited By ~ 1

Author(s):

Vincenzo Russo ◽

Emilio Attena ◽

Anna Rago ◽

Enrico Melillo ◽

Pierpaolo Di Micco ◽

...

Keyword(s):

Diabetes Mellitus ◽

Atrial Fibrillation ◽

Cohort Study ◽

Propensity Score ◽

Incidence Rate ◽

Vitamin K ◽

Real World ◽

Vitamin K Antagonists ◽

Research Database ◽

Thromboembolic Events

Diabetes mellitus (DM) is a chronic metabolic disease which is independently associated with unfavorable clinical outcomes in patients with atrial fibrillation (AF). Few real-world data are available about the clinical performance of non-vitamin K oral anticoagulants (NOACs) among patients with atrial fibrillation and diabetes. The aim of our propensity score-matched cohort study was to compare the safety and effectiveness of Edoxaban versus well-controlled vitamin K antagonists (VKAs) therapy among this population. In this study, we considered patients with AF and diabetes on Edoxaban or VKAs therapy included in the multicenter Atrial Fibrillation Research Database (NCT03760874). The occurrence of major bleedings (MB) and thromboembolic events (a composite of ischemic stroke, transient ischemic attack, systemic embolism) was respectively considered primary safety and effectiveness outcome. We identified 557 AF patients with diabetes who received Edoxaban (n: 230) or VKAs (n: 327) treatment. After propensity score matching analysis, 135 Edoxaban and 135 VKA recipients with similar clinical characteristics were evaluated. The mean follow-up was 27 ± 3 months. The incidence rate of thromboembolic events (TE) was 3.0 per 100 person-years (1.11 in Edoxaban vs. 1.9 in the VKA group, hazard ratio (HR): 0.59; 95% confidence interval (CI), 0.14 to 2.52; p = 0.48). The incidence rate of major bleedings (MB) was 3.7 per 100 person-years (1.2 in Edoxaban vs. 2.7 in the VKA group, HR: 0.43; 95% CI: 0.10 to 1.40; p = 0.14). The incidence rate of intracranial hemorrhage was 0.35 per 100 person-years in Edoxaban vs. 0.74 in the VKA group (HR: 0.49; 95% CI: 0.05 to 5.54; p = 0.56). A positive net clinical benefit (NCB) of Edoxaban over VKAs was found (+1.39). Insulin therapy (HR: 1.76, p = 0.004) and glycated hemoglobin (HR: 1.17, p = 0.002) were found to be independent predictors of TE; moreover, the concomitant use of antiplatelet drugs (HR: 2.41, p = 0.001) was an independent predictor of MB. Conclusions: Our data support the hypothesis of the safety and efficacy of Edoxaban for use in patients with AF and diabetes, justified by a favorable NCB over VKAs.

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Treatment with direct oral anticoagulants or warfarin and the risk for incident diabetes among patients with atrial fibrillation: a population‐based cohort study

Cardiovascular Diabetology ◽

10.1186/s12933-021-01263-0 ◽

2021 ◽

Vol 20 (1) ◽

Author(s):

Ching-Lung Cheung ◽

Chor-Wing Sing ◽

Wallis C. Y. Lau ◽

Gloria H. Y. Li ◽

Gregory Y. H. Lip ◽

...

Keyword(s):

Atrial Fibrillation ◽

Cohort Study ◽

Propensity Score ◽

Cox Regression ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Population Based ◽

Incident Diabetes ◽

Healthcare Database ◽

Cox Regression Analysis

Abstract Background Diabetes mellitus is a common comorbidity of atrial fibrillation (AF), which can complicate the management of AF. The pharmacology of oral anticoagulants (OACs) have been implicated in pathogenesis of diabetes, but the relationship between different OACs and risk of diabetes remains unexamined. This study aimed to evaluate the risk of diabetes with use of different OACs in AF patients. Methods Population-based retrospective cohort study using an electronic healthcare database managed by the Hong Kong Hospital Authority. Patients newly diagnosed with AF from 2014 through 2018 and prescribed OACs were included and followed till December 31, 2019. Inverse probability of treatment weighting based on the propensity score (PS) is used to address potential bias due to nonrandomized allocation of treatment. The risks ofdiabetes were compared between different new OAC users using propensity score-weighted cumulative incidence differences (CID). Results There were 13,688 new users of OACs (warfarin: n = 3454; apixaban: n = 3335; dabigatran: n = 4210; rivaroxaban: n = 2689). The mean age was 75.0 (SD, 11.2), and 6,550 (47.9%) were women. After a median follow-up of 0.93 years (interquartile range, 0.21–1.92 years), 698 incident diabetes cases were observed. In Cox-regression analysis, dabigatran use was significantly associated with reduced risk of diabetes when compared with warfarin use [HR 0.69 (95% CI 0.56–0.86; P < 0.001)], with statistically insignificant associations observed for use of apixaban and rivaroxaban. The corresponding adjusted CIDs at 2 years after treatment with apixaban, dabigatran, and rivaroxaban users when compared with warfarin were − 2.06% (95% CI − 4.08 to 0.16%); − 3.06% (95% CI − 4.79 to − 1.15%); and − 1.8% (− 3.62 to 0.23%). In head-to-head comparisons between women DOAC users, dabigatran was also associated with a lower risk of diabetes when compared with apixaban and rivaroxaban. Conclusions Among adults with AF receiving OACs, the use of dabigatran had the lowest risk of diabetes when compared with warfarin use.

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A Real-world Experience of the Safety and Efficacy of Non-vitamin K Oral Anticoagulants Versus Warfarin in Patients with Non-valvular Atrial Fibrillation— A Single-centre Retrospective Cohort Study in Singapore

Annals of the Academy of Medicine, Singapore ◽

10.47102/annals-acadmedsg.2020184 ◽

2020 ◽

Vol 49 (11) ◽

pp. 838-847

Author(s):

Wen Jun Tiew ◽

Vivien LX Wong ◽

Vern Hsen Tan ◽

Yong Chuan Tan ◽

Elena MS Lee

Keyword(s):

Atrial Fibrillation ◽

Cohort Study ◽

Vitamin K ◽

Major Bleeding ◽

Real World ◽

Retrospective Cohort Study ◽

Retrospective Cohort ◽

Oral Anticoagulants ◽

Single Centre ◽

Safety And Efficacy

Introduction: Non-vitamin K oral anticoagulants (NOACs) were shown to have better outcomes than warfarin for non-valvular atrial fibrillation (NVAF). Given limited local real-world data, this study aims to evaluate the safety and efficacy of NOACs versus warfarin for NVAF in Singapore. Methods: This single-centre retrospective cohort study included 439 patients ≥ 21 years old that were newly prescribed with oral anticoagulants (OACs) for NVAF in 2015. Follow-ups for patients upon OAC initiation lasted either for 2 years or until the occurrence of bleeding or thromboembolism event or death (whichever was earlier). Primary endpoints included major bleeding and stroke, while secondary endpoints included overall bleeding and thromboembolic events. Time-to-events was evaluated via Kaplan-Meier survival analysis. Data on time in therapeutic range (TTR) and compliance were analysed. Results: Patients were assigned to 4 groups: warfarin (157, 35.8%), rivaroxaban (154, 35.1%), apixaban (98, 22.3%) and dabigatran (30, 6.8%). With a mean age of 70.8 (±10.8) years old, the population were predominantly males (56.5%) and comprised Chinese (73.8%), Malays (18.7%) and others (7.5%). The rates of stroke per year were 0.7%, 1.7%, 2.2% and 0% for warfarin, rivaroxaban, apixaban and dabigatran, respectively (P=0.411), whereas those of major bleeding were 2.7%, 1.4%, 2.2% and 0% (P=0.560). As compared to warfarin, no significant differences were observed for risks of stroke and of major bleeding for rivaroxaban (adjusted hazard ratio (HR) 4.19, 95% confidence interval (CI) 0.68–26.05, P=0.124 and adjusted HR 0.43, 95% CI 0.12–1.59, P=0.207) and apixaban (adjusted HR 5.33, 95% CI 0.85–33.34, P=0.074 and adjusted HR 1.54, 95% CI 0.39–6.15, P=0.538). Mean TTR was 68.8% (±24.3%) for warfarin. Compliance rates for rivaroxaban, apixaban, and dabigatran were 56.6%, 59.2%, and 44.8% respectively (P=0.177). Conclusion: NOACs were associated with similar stroke and major bleeding rates as warfarin for NVAF. Keywords: Anticoagulant, Asian, atrial fibrillation, compliance, haemorrhage, thrombosis

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