Non‐vitamin K antagonist oral anticoagulants versus vitamin K antagonists in atrial fibrillation patients with previous stroke or intracranial hemorrhage: A systematic review and meta‐analysis of observational studies

Background: In the clinical trial RE-LY, dabigatran showed a better efficacy/safety profile in comparison with warfarin, but clinical trials are few representative of the real world. We aim to access if dabigatran in real-world patients with atrial fibrillation (AF) showed a better profile in comparison with warfarin, through a systematic review and meta-analysis of observational studies comparing with vitamin K antagonists. Methods: PubMed, Embase and Scopus databases were searched through December 2014. We include observational studies comparing dabigatran to warfarin for non-valvular AF that reported clinical events during a follow-up for dabigatran 75mg, 110 mg or 150 mg, and warfarin. We proceeded to the extraction and analysis of data for clinical thromboembolic events, bleeding and mortality. Data were pooled by meta-analysis using a random-effects model. Results: We selected 9 studies involving a total of 291,703 patients, 85,399 treated with dabigatran and the remaining 206,304 with warfarin. The incidence of stroke was 1.71 / 100 patient-years for dabigatran and 2.44 / 100 patient years for warfarin (relative risk [RR] 0.91, 95% CI 0.66 to 1.27, p=0.58). The major bleeding rate was 3.90 / 100 patient-years for dabigatran and 3.92 / 100 patient years for warfarin (RR 0.90; 0.78 to 1.03, p=0.11). The all-cause mortality (RR 0.81, 0.75-0.88, p<0.001) and intracranial hemorrhage (RR 0.45, from 0.27 to 0.76, p=0.002) were significantly lower in patients treated with dabigatran in comparison to those treated with warfarin. There were no significant differences in risk of myocardial infarction (RR 0.55; 0.29 to 1.07, p=0.08), total hemorrhage (RR 1.00; 0.57 to 1.77, p=0.99), and gastro-intestinal bleeding (RR 1.14; 0.78 to 1.69, p=0.50). Conclusions: In this combined analysis of observational studies of real world, dabigatran compared to warfarin was associated with a similar risk of stroke, myocardial infarction, major bleeding, total bleeding and gastrointestinal bleeding, and a lower risk of intracranial hemorrhage and mortality.

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Direct comparative effectiveness and safety between non-vitamin K antagonist oral anticoagulants for stroke prevention in nonvalvular atrial fibrillation: a systematic review and meta-analysis of observational studies

European Journal of Epidemiology ◽

10.1007/s10654-018-0415-7 ◽

2018 ◽

Vol 34 (2) ◽

pp. 173-190 ◽

Cited By ~ 18

Author(s):

Guowei Li ◽

Gregory Y. H. Lip ◽

Anne Holbrook ◽

Yaping Chang ◽

Torben B. Larsen ◽

...

Keyword(s):

Atrial Fibrillation ◽

Systematic Review ◽

Vitamin K ◽

Stroke Prevention ◽

Comparative Effectiveness ◽

Observational Studies ◽

Meta Analysis ◽

Oral Anticoagulants ◽

Vitamin K Antagonist ◽

Nonvalvular Atrial Fibrillation

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76DEVELOPING A PROTOCOL FOR A SYSTEMATIC REVIEW AND META-ANALYSIS OF OBSERVATIONAL STUDIES COMPARING DIRECT ORAL ANTICOAGULANTS WITH VITAMIN K ANTAGONISTS FOR STROKE PREVENTION IN PEOPLE AGED OVER 75 WITH ATRIAL FIBRILLATION

Age and Ageing ◽

10.1093/ageing/afy135.01 ◽

2018 ◽

Vol 47 (suppl_3) ◽

pp. iii28-iii30

Author(s):

A Mitchell ◽

M C Watson ◽

T Welsh ◽

A McGrogan

Keyword(s):

Atrial Fibrillation ◽

Systematic Review ◽

Vitamin K ◽

Stroke Prevention ◽

Observational Studies ◽

Meta Analysis ◽

Vitamin K Antagonists ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants

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Reappraisal of Non-vitamin K Antagonist Oral Anticoagulants in Atrial Fibrillation Patients: A Systematic Review and Meta-Analysis

Frontiers in Cardiovascular Medicine ◽

10.3389/fcvm.2021.757188 ◽

2021 ◽

Vol 8 ◽

Author(s):

Fuwei Liu ◽

Yunyao Yang ◽

Winglam Cheng ◽

Jianyong Ma ◽

Wengen Zhu

Keyword(s):

Atrial Fibrillation ◽

Systematic Review ◽

Propensity Score ◽

Vitamin K ◽

Major Bleeding ◽

Observational Studies ◽

Meta Analysis ◽

Oral Anticoagulants ◽

Vitamin K Antagonist ◽

Systemic Embolism

Background: Recent observational studies have compared effectiveness and safety profiles between non-vitamin K antagonist oral anticoagulants (NOACs) and warfarin in patients with atrial fibrillation (AF). Nevertheless, the confounders may exist due to the nature of clinical practice-based data, thus potentially influencing the reliability of results. This systematic review and meta-analysis were conducted to compare the effect of NOACs with warfarin based on the propensity score-based observational studies vs. randomized clinical trials (RCTs).Methods: Articles included were systematically searched from the PubMed and EMBASE databases until March 2021 to obtain relevant studies. The primary outcomes were stroke or systemic embolism (SSE) and major bleeding. Hazard ratios (HRs) and 95% confidence intervals (CIs) of the outcomes were extracted and then pooled by the random-effects model.Results: A total of 20 propensity score-based observational studies and 4 RCTs were included. Compared with warfarin, dabigatran (HR, 0.82 [95% CI, 0.71–0.96]), rivaroxaban (HR, 0.80 [95% CI, 0.75–0.85]), apixaban (HR, 0.75 [95% CI, 0.65–0.86]), and edoxaban (HR, 0.71 [95% CI, 0.60–0.83]) were associated with a reduced risk of stroke or systemic embolism, whereas dabigatran (HR, 0.76 [95% CI, 0.65–0.87]), apixaban (HR, 0.61 [95% CI, 0.56–0.67]), and edoxaban (HR, 0.58 [95% CI, 0.45–0.74]) but not rivaroxaban (HR, 0.92 [95% CI, 0.84–1.00]) were significantly associated with a decreased risk of major bleeding based on the observational studies. Furthermore, the risk of major bleeding with dabigatran 150 mg was significantly lower in observational studies than that in the RE-LY trial, whereas the pooled results of observational studies were similar to the data from the corresponding RCTs in other comparisons.Conclusion: Data from propensity score-based observational studies and NOAC trials consistently suggest that the use of four individual NOACs is non-inferior to warfarin for stroke prevention in AF patients.

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Efficacy and Safety of Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation and Cancer in Real World: Meta-Analysis of Retrospective Observational Studies

Journal of Drug Research and Development ◽

10.16966/2470-1009.162 ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

Cao B ◽

Hu X ◽

Chen M ◽

Shen M ◽

Xu L

Keyword(s):

Atrial Fibrillation ◽

Vitamin K ◽

Real World ◽

Observational Studies ◽

Meta Analysis ◽

Vitamin K Antagonists ◽

Oral Anticoagulants ◽

Vitamin K Antagonist ◽

Efficacy And Safety ◽

Patients With Cancer

Background: Evidence on the safety and effectiveness of Non-Vitamin K Antagonist Oral Anticoagulants (NOACs) in Atrial Fibrillation (AF) patients with cancer is rather limited, so we performed this meta-analysis to compare the efficacy and safety of NOACs with vitamin K antagonists (VKAs) in real-world patients with AF and cancer.

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EFFICACY AND SAFETY OF DIRECT ORAL ANTICOAGULANTS VERSUS VITAMIN K ANTAGONISTS IN PATIENTS WITH ATRIAL FIBRILLATION AND BIOPROSTHETIC VALVES: A SYSTEMATIC REVIEW AND META-ANALYSIS

Journal of the American College of Cardiology ◽

10.1016/s0735-1097(21)03083-7 ◽

2021 ◽

Vol 77 (18) ◽

pp. 1727

Author(s):

Neha Patel ◽

Ahmed Elzanaty ◽

Mitra Patel ◽

Eman Elsheikh

Keyword(s):

Atrial Fibrillation ◽

Systematic Review ◽

Vitamin K ◽

Meta Analysis ◽

Vitamin K Antagonists ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Efficacy And Safety ◽

Bioprosthetic Valves

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The Risk of Gastrointestinal Bleeding between Non-Vitamin K Antagonist Oral Anticoagulants and Vitamin K Antagonists in the Asian Atrial Fibrillation Patients: A Meta-Analysis

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18010137 ◽

2020 ◽

Vol 18 (1) ◽

pp. 137

Author(s):

Kuang-Tsu Yang ◽

Wei-Chih Sun ◽

Tzung-Jiun Tsai ◽

Feng-Woei Tsay ◽

Wen-Chi Chen ◽

...

Keyword(s):

Atrial Fibrillation ◽

Gastrointestinal Bleeding ◽

Vitamin K ◽

Meta Analysis ◽

Vitamin K Antagonists ◽

Oral Anticoagulants ◽

Vitamin K Antagonist ◽

Cochrane Library ◽

Secondary Outcome ◽

Optimal Dosage

Background: Non-vitamin K antagonist oral anticoagulants (NOACs) are more commonly used to prevent atrial fibrillation (AF) patients from thromboembolic events than vitamin K antagonists (VKAs). However, the gastrointestinal bleeding (GIB) risk in the Asian AF patients associated with NOACs in comparison with VKAs remained unaddressed. Materials and Methods: A systematic search of studies on NOACs and VKAs in the Asian AF patients was conducted in PubMed, Cochrane Library, and ClinicalTrials.gov. The primary outcome was the hazard ratio (HR) of any GIB associated with NOACs versus VKAs. The secondary outcome was the GIB risks in different kinds of NOACs compared with VKAs. Results: This meta-analysis included two randomized controlled trials (RCTs) and four retrospective studies, comprising at least 200,000 patients in total. A significantly lower HR of GIB risks was found in all kinds of NOACs than VKAs in the Asian AF patients (HR: 0.633; 95% confidence interval: 0.535–0.748; p < 0.001). Additionally, the GIB risks of different NOACs were apixaban (HR: 0.392), edoxaban (HR: 0.603), dabigatran (HR: 0.685), and rivaroxaban (HR: 0.794), respectively. Conclusions: NOACs significantly reduced the risk of GIB in the Asian AF patients compared with VKAs. In the four NOACs compared with VKAs, apixaban probably had a trend of the least GIB risk. We need further head-to-head studies of different NOACs to confirm which NOAC is the most suitable for Asian AF patients and to know the optimal dosage regimen of different NOACs.

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