scholarly journals Impact of direct oral anticoagulant off‐label doses on clinical outcomes of atrial fibrillation patients: A systematic review

2020 ◽  
Vol 86 (3) ◽  
pp. 533-547 ◽  
Author(s):  
Joana Santos ◽  
Natália António ◽  
Marília Rocha ◽  
Ana Fortuna
Keyword(s):  
Atrial Fibrillation ◽  
Systematic Review ◽  
Clinical Outcomes ◽  
Oral Anticoagulant ◽  
Direct Oral Anticoagulant ◽  
Off Label

scholarly journals Effect of Direct Oral Anticoagulant, Patient, and Surgery Characteristics on Clinical Outcomes in the Perioperative Anticoagulation Use for Surgery Evaluation Study

TH Open ◽  
2020 ◽  
Vol 04 (03) ◽  
pp. e255-e262
Author(s):  
Kira MacDougall ◽  
James D. Douketis ◽  
Na Li ◽  
Nathan P. Clark ◽  
Alfonso Tafur ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Renal Function ◽  
Clinical Outcomes ◽  
Oral Anticoagulant ◽  
Management Strategy ◽  
Perioperative Management ◽  
Elective Surgery ◽  
Direct Oral Anticoagulant ◽  
Significant Difference ◽  
Perioperative Anticoagulation

Abstract Introduction The Perioperative Anticoagulation Use for Surgery Evaluation (PAUSE) Study assessed a standardized perioperative management strategy in patients with atrial fibrillation who were taking a direct oral anticoagulant (DOAC) and required an elective surgery or procedure. The aim of this substudy is to analyze the safety of this management strategy across different patient subgroups, according to four presurgical variables: (1) DOAC type and dose, (2) surgery/procedure bleed risk, (3) patient renal function, and (4) age. Methods Clinical outcomes analyzed included major bleeding (MB), arterial thromboembolism, any bleeding, and any thromboembolism. We used descriptive statistics to summarize clinical outcomes, where the frequency, proportion, and 95% confidence interval were reported. Fisher's exact tests were used for testing the null hypothesis of independence between the clinical outcome and patient characteristic, where the test p-values were reported. Results There were 3,007 patients with atrial fibrillation requiring perioperative DOAC management. There was no significant difference in bleeding or thromboembolic outcomes according to DOAC type/dose regimen, renal function, or patient age. The rate of MB was significantly higher with high bleed risk procedures than low bleed risk procedures in apixaban-treated patients (2.9 vs. 0.59%; p < 0.01), but not in dabigatran-treated patients (0.88 vs. 0.91%; p = 1.0) or rivaroxaban-treated patients (2.9 vs. 1.3%; p = 0.06). The risk for thromboembolism did not differ according to surgery/procedure-related bleed risk. Conclusion Our results suggest that in DOAC-treated patients who received standardized perioperative management, surgical bleed risk is an important determinant of bleeding but not thromboembolic outcomes, although this finding was not consistent across all DOACs. There were no differences in bleeding and thromboembolism according to DOAC type and dose, renal function, or age.

scholarly journals A systematic review of direct oral anticoagulant use in chronic kidney disease and dialysis patients with atrial fibrillation

2018 ◽  
Vol 34 (2) ◽  
pp. 265-277 ◽  
Author(s):  
Jordanne Feldberg ◽  
Param Patel ◽  
Ashley Farrell ◽  
Sylvia Sivarajahkumar ◽  
Karen Cameron ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Systematic Review ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Oral Anticoagulant ◽  
Direct Oral Anticoagulant ◽  
Dialysis Patients

scholarly journals Does body mass index influence clinical outcomes in patients with atrial fibrillation who receive direct oral anticoagulant therapy

2021 ◽  
Vol 16 (1-2) ◽  
pp. 67-67
Author(s):  
Ivana Jurin ◽  
Marko Lucijanić ◽  
Anđela Jurišić ◽  
Aleksandar Blivajs ◽  
Boris Starčević ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Body Mass Index ◽  
Clinical Outcomes ◽  
Body Mass ◽  
Anticoagulant Therapy ◽  
Oral Anticoagulant ◽  
Oral Anticoagulant Therapy ◽  
Direct Oral Anticoagulant

scholarly journals Real-World Prevalence of Direct Oral Anticoagulant Off-Label Doses in Atrial Fibrillation: An Epidemiological Meta-Analysis

2021 ◽  
Vol 12 ◽  
Author(s):  
Nan-Nan Shen ◽  
Chi Zhang ◽  
Ying Hang ◽  
Zheng Li ◽  
Ling-Cong Kong ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Real World ◽  
Oral Anticoagulant ◽  
Meta Analysis ◽  
Anticoagulation Therapy ◽  
Direct Oral Anticoagulant ◽  
Prevalence Data ◽  
Off Label ◽  
Significant Difference ◽  
Subgroup Analyses

Background: The use of direct oral anticoagulant (DOAC) off-label doses in atrial fibrillation (AF) patients may result in poor clinical outcomes. However, the true prevalence remains scarce. This study aims at estimating the prevalence of DOAC off-label doses in AF patients.Methods: Databases of MEDLINE, EMBASE, and COCHRANE were searched from inception through February 2020 for real-world studies that reported the off-label definition and prevalence data of AF patients using DOACs. The primacy outcomes were the overall prevalence of DOAC off-label doses and the corresponding underdose and overdose. The random-effects model was used for data synthesis. Variations on individual DOAC and different regions were examined by subgroup analyses.Results: A total of 23 studies involving 162,474 AF patients were finally included. The overall prevalence of DOAC off-label doses was 24% (95% CI, 19–28%), with 18% for dabigatran, 27% for rivaroxaban, 24% for apixaban, and 26% for edoxaban. The prevalence of underdosed DOACs was 20% (95% CI, 16–24%) with significant difference among individual anticoagulants (13% for dabigatran, 22% for rivaroxaban, 22% for apixaban, and 18% for edoxaban; Pinteraction=0.02). The prevalence of overdosed DOACs was 5% (95% CI, 3–7%), with the lowest prevalence observed in apixaban (2%). Subgroup analyses by regions demonstrated that the prevalence of DOAC off-label doses was higher in Asia (32%) than in North America (14%) and in Europe (22%), with underdose being predominant. Regardless of different regions, the prevalence of overdose was relatively low (4–6%).Conclusion: This study provides an estimation of DOAC off-label doses in the real-world setting. The prevalence rate of DOAC off-label doses in AF patients was relatively high, with underdose being predominant. Clinicians in Asia preferred to prescribe underdose of DOACs to AF patients. More evidence about the appropriateness of DOAC off-label doses in AF patients is urgently needed. Education programs concerning the appropriate prescription of DOACs within the drug labels and accepted guidelines are necessary to DOAC prescribers to ensure the safety and effectiveness of anticoagulation therapy for patients with AF.

The Atrial Fibrillation Better Care (ABC) pathway in atrial fibrillation: a systematic review and meta-analysis of 285,000 patients

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
GF Romiti ◽  
D Pastori ◽  
JM Rivera-Caravaca ◽  
WY Ding ◽  
YX Gue ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Systematic Review ◽  
Clinical Outcomes ◽  
Major Bleeding ◽  
Meta Analysis ◽  
Random Effect ◽  
Significant Proportion ◽  
Cardiovascular Death ◽  
Current Evidence ◽  
Meta Regression

Abstract Funding Acknowledgements Type of funding sources: None. Background The ‘Atrial Fibrillation Better Care’ (ABC) pathway has been recently proposed as a holistic approach for the comprehensive management of patients with Atrial Fibrillation (AF), standing on three main pillars: ‘A’ Avoid stroke (with Anticoagulants); ‘B’ Better symptom management; ‘C’ Cardiovascular and Comorbidity management. The ABC pathway is now recommended in several clinical guidelines, including the recent European Society of Cardiology (ESC) AF management guidelines. We performed a systematic review of the current evidence for use of the ABC pathway on clinical outcomes. Methods We performed a systematic review and meta-analysis according to PRISMA Guidelines. Pubmed and EMBASE were searched for studies reporting the prevalence of ABC pathway adherent management in AF patients, and its impact on clinical outcomes (all-cause death, cardiovascular death, stroke, and major bleeding). Metanalysis of odds ratio (OR) was performed with random-effect models; subgroup analysis and meta-regression were performed to account for heterogeneity; a CHA2DS2-VASc-stratified sensitivity analysis was also performed. Results Among 2862 records retrieved from the literature search, 8 studies were included. The pooled prevalence of ABC adherent management was 21% (95% confidence intervals (CI), 13-34%), with a high grade of heterogeneity; in a multivariable meta-regression model, adherence to each criteria of the ABC pathway explained most part of the heterogeneity (R2 = 98.9%). Patients treated according to the ABC pathway showed a lower risk of all-cause death (OR:0.42, 95%CI 0.31-0.56), cardiovascular death (OR:0.37, 95%CI 0.23-0.58), stroke (OR:0.55, 95%CI 0.37-0.82) and major bleeding (OR:0.69, 95%CI 0.51-0.94), with moderate heterogeneity. Meta-regressions showed that the increasing prevalence of diabetes mellitus, coronary artery disease, chronic heart failure and history of stroke were associated with a reduced effectiveness of the ABC pathway for all-cause and cardiovascular death; each comorbidity was able to explain a significant proportion of heterogeneity at univariate meta-regression. Conversely, longer follow-up time was associated with more effectiveness of the ABC pathway for all outcomes. Adherence to ABC pathway was associated with a progressively greater reduction of the all-cause death risk amongst patients with higher CHA2DS2-VASc scores; no difference in ABC pathway effectiveness was found across CHA2DS2-VASc strata for CV death and stroke occurrence. Conclusions Adherence to the ABC pathway was suboptimal, being adopted in 1 in every 5 patients. Adherence to the ABC pathway was associated with a reduction in the risk of major adverse outcomes. Our data supports extensive application of the ABC pathway for the management of AF. Abstract Figure.

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