COMPARISON OF EFFECTIVENESS, SAFETY, AND THE NET CLINICAL OUTCOME BETWEEN DIFFERENT DIRECT ORAL ANTICOAGULANTS IN 162,707 NON-VALVULAR ATRIAL FIBRILLATION PATIENTS TREATED IN US CLINICAL PRACTICE

Aim. To study the frequency of prescribing antithrombotic agents in patients with non-valvular atrial fibrillation (AF) in real clinical practice, to evaluate changes of prescriptions from 2012 till 2020.Material and methods. The medical records of inpatients (Form 003/y) with the diagnosis AF, hospitalized in the cardiological department were analyzed. According to the inclusion criteria, the patients were over 18 years of age, established diagnosis of non-valvular AF. There were two exclusion criteria: congenital and acquired valvular heart disease and prosthetic heart valves. In retrospective analysis we have included 263 case histories in 2012, 502 ones in 2016 and 524 in 2020. CHA2DS2-VASc score was used for individual stroke risk assessment in AF. The rational use of the antithrombotic therapy was evaluated according with current clinical practice guidelines at analyzing moment.Results. During period of observation the frequency of antiplatelet therapy significantly decreased from 25,5% to 5,5% (р<0.001), decreased the frequency of administration of warfarin from 71,9% to 18,3% (р<0.001). The frequency of use of direct oral anticoagulants increased in 2020 compared to 2016 (р<0.001). For patients with a high risk of stroke anticoagulant therapy was administered in 71.8% of cases in 2012, 88.5% in 2016 and 92.5% in 2020. Before discharge from hospital majority of patients (72%) achieved a desired minimum international normalized ratio (INR) from 2.0 to 3.0 in 2012. In 2016 and 2020 an only 33% and 40.6% of patients achieved INR (2.0-3.0).Conclusion. Doctors have become more committed to following clinical guidelines during the period of the investigation. In 2020 antithrombotic therapy for atrial fibrillation was suitable according to current clinical guidelines.

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EFFICACY AND SAFETY OF DIRECT ORAL ANTICOAGULANTS IN THE PREVENTION OF STROKE IN PATIENTS WITH NONVALVULAR ATRIAL FIBRILLATION IN EVERYDAY CLINICAL PRACTICE: FACTS ABOUT RIVAROXABAN

Atherothrombosis Journal ◽

10.21518/2307-1109-2016-1-69-80 ◽

2016 ◽

pp. 69-80

Author(s):

I. S. Yavelov

Keyword(s):

Atrial Fibrillation ◽

Clinical Practice ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Efficacy And Safety ◽

Nonvalvular Atrial Fibrillation ◽

Everyday Clinical Practice

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Atrial fibrillation in old age: risk management and features of the use of direct oral anticoagulants

Kardiologiia ◽

10.18087/cardio.2021.6.n1627 ◽

2021 ◽

Vol 61 (6) ◽

pp. 79-87

Author(s):

S. G. Kanorskii

Keyword(s):

Atrial Fibrillation ◽

Clinical Practice ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Clinical Situation ◽

The Russian Federation ◽

Coronary Events ◽

Senile Patient ◽

Reduced Risk ◽

Real Clinical Practice

Senile patients with atrial fibrillation (AF) are at a higher risk of thromboembolism and hemorrhage than younger patients. Three direct oral anticoagulants (DOAC), apixaban, dabigatran, and rivaroxaban, are registered in the Russian Federation and are extensively used for prevention of stroke in patients with AF. The DOAC treatment of older patients requires considering peculiarities of these patients, clinical situation and properties of individual drugs to achieve the balance of efficiency and safety and a comprehensive protection. According to studies of real clinical practice DOAC may have advantages over warfarin (reduced risk of fractures, diabetes mellitus, and dementia). Compliance with and constancy of the DOAC treatment are important for its efficiency, particularly in senile age. Results of clinical trials and real clinical practice studies have confirmed that rivaroxaban may provide a comprehensive protection for a senile patient with AF due to favorable indexes of efficiency and safety, beneficial effect on the risk of coronary events and impairment оf renal function, whereas once a day dosing of rivaroxaban improves the compliance with this treatment and its constancy.

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Clinical efficacy and safety of direct oral anticoagulants in patients with atrial fibrillation in real-world clinical practice

Russian Medical Inquiry ◽

10.32364/2587-6821-2021-5-4-196-199 ◽

2021 ◽

Vol 5 (4) ◽

pp. 196-199

Author(s):

M.V. Khruslov ◽

◽

A.S. Sorokina ◽

Yu.A. Sapel'nikova ◽

T.V. Vavilova ◽

...

Keyword(s):

Atrial Fibrillation ◽

Clinical Practice ◽

Clinical Efficacy ◽

Real World ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Bleeding Complications ◽

Efficacy And Safety ◽

Daily Group ◽

Thrombotic Complications

Aim: to assess the efficacy and safety of direct oral anticoagulants (DOACs) in patients with atrial fibrillation (AFib) in real-world clinical practice. Patients and Methods: this non-interventional prospective study enrolled 356 patients aged 50-75 years with AFib and creatinine clearance ≥50 ml/min. All patients were divided into three age-matched groups based on DOACs prescribed. Group 1 patients (n=120) received rivaroxaban 20 mg daily. Group 2 patients (n=112) received dabigatran etexilate 150 mg twice daily. Group 3 patients (n=124) received apixaban 5 mg twice daily. The groups were comparable in comorbidities and the risks of thrombotic and hemorrhagic complications. Followup was 2 years after starting treatment. Thrombotic complications, massive bleedings, and death for any reason were considered end-points. Results: no significant differences in the rate of cardiogenic thrombotic complications between the groups were reported. In patients who received apixaban, fewer bleeding complications were diagnosed (insignificant differences). Conclusions: the efficacy and safety of DOACs in patients over 50 years are similar. KEYWORDS: atrial fibrillation, oral anticoagulants, thrombotic complications, infarction, stroke, bleedings. FOR CITATION: Khruslov M.V., Sorokina A.S., Sapel'nikova Yu.A., Vavilova T.V. Clinical efficacy and safety of direct oral anticoagulants in patients with atrial fibrillation in real-world clinical practice. Russian Medical Inquiry. 2021;5(4):196–199 (in Russ.). DOI: 10.32364/2587-6821-2021-5-4-196-199.

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Abstract WP236: Trends in Antithrombotic Therapy Use and Clinical Outcome in Acute Ischemic Stroke and Atrial Fibrillation in a Hispanic Population in the Era of Direct Oral Anticoagulants

Stroke ◽

10.1161/str.50.suppl_1.wp236 ◽

2019 ◽

Vol 50 (Suppl_1) ◽

Author(s):

Fernando Daniel Flores-Silva ◽

Erwin Chiquete ◽

Francisco Martinez-Carrillo ◽

Pedro Gomez-Brockmann ◽

Juan Esteban Montes-Ramirez ◽

...

Keyword(s):

Atrial Fibrillation ◽

Ischemic Stroke ◽

Clinical Outcome ◽

Acute Ischemic Stroke ◽

Antithrombotic Therapy ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Hispanic Population

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Off-label underdosed apixaban use in Asian patients with non-valvular atrial fibrillation

EP Europace ◽

10.1093/europace/euab116.281 ◽

2021 ◽

Vol 23 (Supplement_3) ◽

Author(s):

SR Lee ◽

EK Choi ◽

SH Park ◽

JH Jung ◽

KD Han ◽

...

Keyword(s):

Atrial Fibrillation ◽

Ischemic Stroke ◽

Clinical Outcome ◽

Dose Reduction ◽

Standard Dose ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Off Label ◽

Funding Sources ◽

Asian Patients

Abstract Funding Acknowledgements Type of funding sources: None. Background In Asian patients with atrial fibrillation (AF), off-label underdosed prescriptions of direct oral anticoagulants (DOACs) are common Purpose We aimed to compare the effectiveness and safety of off-label underdosed apixaban with on-label standard dose apixaban in Asian patients with AF. Methods Using the Korean nationwide claims database, we identified patients who prescribed apixaban and did not fulfill the dose reduction criteria of apixaban between January 2015 and December 2017. Multivariable Cox hazard regression model was performed and hazard ratios (HRs) for ischemic stroke, major bleeding (MB), all-cause death, and the composite clinical outcome were analyzed. Results Compared to patients prescribed on-label standard dose apixaban (n = 4,194), patients prescribed off-label underdosed apixaban (n = 2,890) were associated with higher risks of ischemic stroke (adjusted HR [aHR] 1.38, 95% confidence interval [CI] 1.06-1.81), all-cause death (aHR 1.19, 95% CI 1.01-1.39) and the composite clinical outcome (aHR 1.17, 95% CI 1.03-1.34), but with no significant differences in MB between the two groups (Figure). In patients without any dose reduction criteria, off-label underdosed apixaban use was associated with a significantly higher risk of ischemic stroke than on-label standard dose apixaban use (aHR 1.85, 95% 1.25-2.73); however, in patients who had single dose reduction criteria (age ≥80 years, serum creatinine ≥1.5mg/dL, or bodyweight ≤60 kg), off-label underdosed apixaban use did not show a significant overall benefit in the composite clinical outcome compared with on-label standard dose apixaban, but was associated with a higher risk of all-cause death (aHR 1.32, 95% CI 1.07-1.64). Conclusion Off-label underdosed apixaban use was associated with higher risks of ischemic stroke, all-cause death, and composite clinical outcome and comparable risk of MB compared with on-label standard dose apixaban use. Label-adherence of apixaban dosing should be emphasized to achieve the best clinical outcome for Asian patients with non-valvular AF, especially in those without any dose reduction criteria. Abstract Figure.

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Effectiveness and Safety of Under or Over-dosing of Direct Oral Anticoagulants in Atrial Fibrillation: A Systematic Review and Meta-analysis of 148909 Patients From 10 Real-World Studies

Frontiers in Pharmacology ◽

10.3389/fphar.2021.645479 ◽

2021 ◽

Vol 12 ◽

Author(s):

Nan-Nan Shen ◽

Chi Zhang ◽

Na Wang ◽

Jia-Liang Wang ◽

Zhi-Chun Gu ◽

...

Keyword(s):

Atrial Fibrillation ◽

Clinical Practice ◽

Confidence Interval ◽

Major Bleeding ◽

Meta Analysis ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Cochrane Library ◽

Asian Patients ◽

Increased Risk

Background: In routine clinical practice, non-standard doses of direct oral anticoagulants (DOACs) are commonly used in patients with atrial fibrillation (AF). However, data on the clinical outcomes of non-standard doses of DOACs are limited.Methods: The MEDLINE, Embase, and Cochrane Library databases were systematically searched from their inception until 30 June 2020 for studies that reported the effectiveness or safety outcomes of non-standard doses of DOACs compared with on-label doses of DOACs in patients with atrial fibrillation. Non-standard doses of DOACs were defined as under or over-dose of DOACs based on the recommended standard doses in drug labels. A random-effects meta-analysis was performed to calculate the pooled hazard ratio and associated 95% confidence interval (95% confidence interval). Subgroup analyses were conducted according to individual DOACs and different geographic regions.Results: Ten articles involving 148,909 patients with AF were included. There were no significant differences between under-dosing and on-label dosing with respect to stroke/systematic embolism (HR: 1.01, 95% CI: 0.93–1.09), major bleeding (HR: 0.98, 95% CI: 0.77–1.19), intracranial haemorrhage (HR: 1.07, 95% CI: 0.74–1.40), gastrointestinal bleeding (HR: 1.10, 95% CI: 0.82–1.39), and myocardial infarction (HR: 1.07, 95% CI: 0.89–1.25), except for an increased risk of death (HR: 1.37, 95% CI: 1.01–1.73). We observed a significant association between over-dosing of DOACs and increased risk of stroke/systematic embolism (HR: 1.18, 95% CI: 1.04–1.32), major bleeding (HR: 1.16, 95% CI: 1.03–1.29), and death (HR: 1.21, 95% CI: 1.03–1.38) compared with on-label dosing. Furthermore, over-dosing of DOACs increased the risk of stroke/systematic embolism (HR: 1.16; 95% CI: 1.00–1.33) and major bleeding events (HR: 1.18; 95% CI: 1.00–1.37) in Asian patients.Conclusion: A reduced dose of DOACs might be safely and effectively used in clinical practice, especially in Asian patients, whereas high-dose DOACs might not be well tolerated by Asian patients.

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