Patients with diabetes mellitus and atrial fibrillation treated with NOACs: Meta-analysis of 8 outcomes in 58, 634 patients across 4 randomized controlled trials

Author(s):  
Anna Plitt ◽  
Thomas A Zelniker ◽  
Jeong-Gun Park ◽  
Darren K McGuire ◽  
Christian T Ruff ◽  
...  

Abstract Aims Concomitant atrial fibrillation (AF) and diabetes mellitus (DM) increases risk of stroke and systemic embolic events. This meta-analysis assessed the benefit/risk balance of non-vitamin K antagonist oral anticoagulants (NOACs) vs warfarin, and explored whether there was effect modification by DM or heterogeneity in outcomes between NOACs in patients with and without DM. Methods We performed a meta-analysis of 58,634 patients from four phase 3 trials of NOAC vs warfarin in patients with AF, comparing the primary outcomes of efficacy and safety and 6 other secondary outcomes in patients stratified by the presence of DM. Interaction testing was used to assess for heterogeneity of treatment effects. A meta-regression was performed to evaluate the influence of baseline characteristics. Results NOACs reduced the risk of stroke/SEE in 18,134 patients with DM [hazard ratio (HR) 0.80; 95% confidence interval (CI) (0.69-0.93), I2 3.90] to a similar degree as in 40,500 patients without DM [HR 0.82; 95% CI (0.74-0.91)], I2 16.33 p-int 0.81). There was no effect modification of DM on the relative reduction with NOACs vs warfarin in major bleeding (DM : 0.95, 95% CI 0.75-1.20, I2 43.83; no DM: 0.83, 95% CI 0.55-1.24; I2 87.90; p-int 0.37). Intracranial Haemorrhage (HRs 0.51 and 0.47, p-int 0.70) and cardiovascular death (HRs 0.87 and 0.90, p-int 0.70) were significantly reduced by NOACs in the presence or absence of DM. Conclusion NOACs are more effective and safer than warfarin in AF patients with or without DM and absent contraindications, NOACs should be the anticoagulation treatment choice in diabetics.

Kardiologiia ◽  
2020 ◽  
Vol 60 (7) ◽  
pp. 108-114
Author(s):  
A. G. Obrezan ◽  
N. V. Kulikov

Atrial fibrillation is one of the most common concomitant diseases in patients with diabetes mellitus (DM). Meta-analyses of multiple studies have shown that the risk of AF is higher for diabetic patients with impaired glucose homeostasis than for patients without DM. Patients with AF and DM were younger, more frequently had arterial hypertension, chronic kidney disease, heart failure, and ischemic heart disease, and stroke and were characterized with a more severe course of AF. The article discusses possible mechanisms of the mutually aggravating effects of DM and AF, scales for evaluating the risk of bleeding (CHADS2, CHA2DS2‑VASc, HAS-BLED), and the role of anticoagulants. A meta-analysis of 16 randomized clinical studies, including 9 874 patients, has demonstrated the efficacy of oral anticoagulants in prevention of stroke with an overall decrease in the relative risk by 62 % compared to placebo (95% confidence interval, from 48 to 72 ). For prevention of complications in patients with AF and DM, current antithrombotic therapies can be used, specifically the oral factor Xa inhibitor, rivaroxaban, which is the best studied in patients with AF and DM and represents a possible alternative to warfarin in such patients.


EP Europace ◽  
2015 ◽  
Vol 17 (10) ◽  
pp. 1518-1525 ◽  
Author(s):  
Matteo Anselmino ◽  
Mario Matta ◽  
Fabrizio D'ascenzo ◽  
Carlo Pappone ◽  
Vincenzo Santinelli ◽  
...  

2021 ◽  
Vol 2021 ◽  
pp. 1-14
Author(s):  
Bo Cao ◽  
Xingcan Yao ◽  
Lifang Zhang ◽  
Xiaobo Hu ◽  
Min Chen ◽  
...  

Background. This meta-analysis was performed to compare the efficacy and safety of direct oral anticoagulants (DOACs) with vitamin K antagonists (VKAs) for stroke prevention in real-world patients with diabetes and nonvalvular atrial fibrillation (NVAF) through observational studies. Methods. PubMed, Embase, and Web of Science databases were searched up to August 2020 for eligible studies. Outputs were presented as risk ratios (RRs) and corresponding 95% confidence intervals (CIs) by using a random-effect model. Results. Seven observational studies involving 249,794 diabetic NVAF patients were selected. Compared with VKAs, the use of DOACs was associated with significantly reduced risks of stroke ( RR = 0.56 , 95% CI 0.45-0.70; p < 0.00001 ), ischemic stroke ( RR = 0.61 , 95% CI 0.48-0.78; p < 0.0001 ), stroke or systemic embolism (SSE) ( RR = 0.81 , 95% CI 0.68-0.95; p = 0.01 ), myocardial infarction ( RR = 0.69 , 95% CI 0.55-0.88; p = 0.002 ), major bleeding ( RR = 0.75 , 95% CI 0.63-0.90; p = 0.002 ), intracranial hemorrhage ( RR = 0.50 , 95% CI 0.44-0.56; p < 0.00001 ), and major gastrointestinal bleeding ( RR = 0.77 , 95% CI 0.62-0.95; p = 0.02 ), and a borderline significant decrease in major adverse cardiac events ( RR = 0.87 , 95% CI 0.75-1.00; p = 0.05 ) in NVAF patients with diabetes. Conclusion. For patients with NVAF and diabetes in real-world clinical settings, DOACs showed superior efficacy and safety profile over VKAs and significantly reduced risks of stroke, ischemic stroke, SSE, myocardial infarction, major bleeding, intracranial hemorrhage, and major gastrointestinal bleeding.


2018 ◽  
Vol 8 (6) ◽  
pp. 554-561 ◽  
Author(s):  
Thomas A Zelniker ◽  
Christian T Ruff ◽  
Elliott M Antman ◽  
Robert P Giugliano

Background: Patients with atrial fibrillation and concomitant coronary artery disease (CAD) are at higher risk for myocardial infarction or cardiovascular death, often require antiplatelet therapy and are therefore exposed to an increased risk of bleeding. This meta-analysis aimed to compare the efficacy and safety profile of non-vitamin K antagonist oral anticoagulants (NOACs) with warfarin in patients with atrial fibrillation and concomitant CAD. Materials and methods: We performed a trial-level meta-analysis of CAD subgroups from four trials of NOAC versus warfarin in patients with atrial fibrillation, comparing the primary trial endpoints (efficacy: stroke or systemic embolic event; safety: International Society on Thrombosis and Haemostasis major bleeding) in patients with versus those without CAD, and used interaction testing to assess for treatment effect modification. Results: In total, 58,606 patients with established CAD were included in this meta-analysis. NOACs reduced the risk of stroke/systemic embolic event irrespective of presence of CAD (CAD: 0.76 (0.56–1.04); no CAD: hazard ratio 0.77 (0.56–1.06); p-INT 0.93). Similarly, there was no effect modification by presence of CAD for major bleeding (CAD: hazard ratio 0.92 (0.65–1.32), no CAD: 0.83 (0.61–1.12); p-INT 0.46) or myocardial infarction (CAD: hazard ratio 0.95 (0.62–1.44); no CAD: hazard ratio 0.95 (0.60–1.50); p-INT = 0.98). While NOACs reduced all-cause mortality in patients without CAD compared with warfarin (hazard ratio 0.85 (0.71–1.02)), there was no difference in mortality between NOACs and warfarin in the CAD group (hazard ratio 0.99 (0.82–1.20); p-INT 0.01). Conclusion: The present meta-analysis of four trials supports that NOACs are safe and at least as effective as warfarin in patients with atrial fibrillation and established CAD.


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
C Arreaga-Perez ◽  
D Evangelista-Barragan ◽  
A Zarate-Zapata ◽  
E Penaherrera ◽  
J J Zuniga-Bohorquez ◽  
...  

Abstract Introduction Warfarin, despite its limitations, is still used as standard treatment in patients with Atrial Fibrillation, but it has been demonstrated that Direct Oral Anticoagulants (DOAC) offer many advantages over warfarin in the prevention of strokes. Purpose The goal was to determinate the safety and effectiveness in reducing systemic thromboembolism, ischemic stroke, hemorrhagic stroke, cerebral hemorrhage and cardiovascular mortalityof the direct oral anticoagulants (DOACs) over warfarin in patients with non-valvular atrial fibrillation, conducting an analysis of the studies of DOACs, including the ENGAGE study on the use of edoxaban, affirming its safety including the pivotal essays available. Method A systematic search of PubMed's bibliographic database was made for the selection of the articles.Clinical essays from less than 10 years, in phase III and multicentric studies were selected. Results The main objective was the significant reduction in the incidence of stroke/systemic thromboembolism with the use of DOACs vs. Warfarin (2,73% vs. 3,24%), the reduction of hemorrhagic stroke was (0.41% vs. 0.94%), ischemic stroke (3.12% vs. 3.5%), cardiovascular death with DOACs was 6.02% vs. Warfarin 6.84%, (compared with previous studies that demonstrated effectiveness with max doses affirming safety and effectiveness). Conclusion Our meta-analysis is the first to date to evaluate all the pivotal trials published,we include the ENGAGE trial. In non-valvular atrial fibrillation, the use of DOACs, in comparison with Warfarin, significantly reduced the risk of stroke/systemic thromboembolism by 16.3%, ischemic stroke by 11.1%, hemorrhagic stroke by 54.6%, cardiovascular mortality by 12.9%. FUNDunding Acknowledgement Type of funding sources: None.


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