Clinical Outcomes of Off-Label Underdosing of Direct Oral Anticoagulants After Ablation for Atrial Fibrillation

Wakamatsu, Yuji; Nagashima, Koichi; Watanabe, Ryuta; Arai, M.; Yokoyama, Kenichi; Matsumoto, Naoya; Otsuka, Takayuki; Suzuki, Shinya; Hirata, Akio; Murakami, Masato; Takami, Mitsuru; Kimura, Masaomi; Fukaya, Hidehira; Kato, Takeshi; Hayashi, Hiroshi; Iwasaki, Yu‐ki; Shimizu, Wataru; Nakajima, Ikutaro; Harada, Tomoo; Koyama, Junjiroh; Okumura, Ken; Tokuda, Michifumi; Yamane, Teiichi; Tanimoto, Kojiro; Momiyama, Yukihiko; Nonoguchi, Noriko; Soejima, Kyoko; Ejima, Koichiro; Hagiwara, Nobuhisa; Harada, Masahide; Sonoda, Kazumasa; Inoue, Masato; Kumagai, Koji; Hayashi, Hidemori; Yazaki, Yoshinao; Sato, Kazuhiro; Watari, Yuji; Okumura, Yasuo

doi:10.1536/ihj.20-335

Cited by 11 publications

(7 citation statements)

References 29 publications

(34 reference statements)

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“…Indeed, association between non-recommended low DOACs dose and reduced efficacy of DOACs in AF has been observed in some of the previous studies, 44 , 45 but not in all. 46 , 47 In our exploratory analysis we did not observe a relationship between non-recommended low dose and thromboembolic complications. This may be related to the low rate of this outcome.…”

Section: Discussionmentioning

confidence: 55%

Prescribing Errors With Direct Oral Anticoagulants and Their Impact on the Risk of Bleeding in Patients With Atrial Fibrillation

Raccah

Erlichman

Pollak

et al. 2021

J Cardiovasc Pharmacol Ther

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Introduction: Anticoagulants are associated with significant harm when used in error, but there are limited data on potential harm of inappropriate treatment with direct oral anticoagulants (DOACs). We conducted a matched case-control study among atrial fibrillation (AF) patients admitting the hospital with a chronic treatment with DOACs, in order to assess factors associated with the risk of major bleeding. Methods: Patient data were documented using hospital’s computerized provider order entry system. Patients identified with major bleeding were defined as cases and were matched with controls based on the duration of treatment with DOACs and number of chronic medications. Appropriateness of prescribing was assessed based on the relevant clinical guidelines. Conditional logistic regression was used to evaluate the potential impact of safety-relevant prescribing errors with DOACs on major bleeding. Results: A total number of 509 eligible admissions were detected during the study period, including 64 cases of major bleeding and 445 controls. The prevalence of prescribing errors with DOACs was 33%. Most prevalent prescribing errors with DOACs were “drug dose too low” (16%) and “non-recommended combination of drugs” (11%). Safety-relevant prescribing errors with DOACs were associated with major bleeding [adjusted odds ratio (aOR) 2.17, 95% confidence interval (CI) 1.14-4.12]. Conclusion: Prescribers should be aware of the potential negative impact of prescribing errors with DOACs and understand the importance of proper prescribing and regular follow-up.

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Section: Discussionmentioning

confidence: 55%

Prescribing Errors With Direct Oral Anticoagulants and Their Impact on the Risk of Bleeding in Patients With Atrial Fibrillation

Raccah

Erlichman

Pollak

et al. 2021

J Cardiovasc Pharmacol Ther

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“…Compared with the patients enrolled in phase 3 randomized controlled trials, patients in routine clinical practice are older, more frail, more likely to have chronic kidney disease, have a history of major and/or clinically relevant non-major bleeding and/or gastrointestinal bleeding, and more likely to receive concomitant antiplatelet therapy and/or interacting drugs [8]. As a result, the prescription of low doses of direct oral anticoagulants (appropriate or inappropriate) is more common in real-life settings [9,10,12,[14][15][16]. This considerable difference in the prescription of reduced doses of direct oral anticoagulants between randomized controlled trials and real-world studies may be due to numerous reasons, including patient-related factors such as advanced age, frailty, and the presence of multiple comorbidities, or physician-related factors such as lack of awareness about the recommendations of the guidelines and/or fear of bleeding and other adverse events.…”

Section: Methodsmentioning

confidence: 99%

“…Despite the presence of speci c dose reduction criteria for each direct oral anticoagulant, inappropriate dosing of direct oral anticoagulants in patients with atrial brillation is not uncommon in real-life settings [8,11]. Real-world studies reported that the prevalence of inappropriate dosing of direct oral anticoagulants vary between 12.8-39% [9][10][11][12][13][14][15][16].…”

Section: Introductionmentioning

confidence: 99%

PrevAleNce and Associated factors of inappropriaTe dosing of direct Oral anticoaguLants In pAtients with Atrial Fibrillation: the ANATOLIA-AF Study

Kocabaş

Ergin

Yavuz

et al. 2022

Cardiovasc Drugs Ther

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Purpose: Inappropriate dosing of direct oral anticoagulants is associated with an increased risk of stroke, systemic embolism, major bleeding, cardiovascular hospitalization, and death in patients with atrial brillation. The main goal of the study was to determine the prevalence and associated factors of inappropriate dosing of direct oral anticoagulants in real-life settings.Methods: This study was a multicenter, cross-sectional, observational study that included 2,004 patients with atrial brillation. The study population was recruited from 41 cardiology outpatient clinics between January and May 2021. The main criteria for inappropriate direct oral anticoagulant dosing were de ned according to the recommendations of the European Heart Rhythm Association.Results: The median age of the study population was 72 years and 58% were women. Nine hundred and eighty-seven patients were prescribed rivaroxaban, 658 apixaban, 239 edoxaban, and 120 dabigatran. A total of 498 patients (24.9%) did not receive the appropriate dose of direct oral anticoagulants. In a logistic regression model, advanced age, presence of chronic kidney disease, presence of permanent atrial brillation, prescription of reduced doses of direct oral anticoagulants, prescription of edoxaban treatment, concomitant use of amiodarone treatment, and non-use of statin treatment were signi cantly associated with potentially inappropriate dosing of direct oral anticoagulants. Conclusion:The study demonstrated that the prevalence of inappropriate direct oral anticoagulant dosing according to the European Heart Rhythm Association recommendations was 24.9% in patients with atrial brillation. Several demographic and clinical factors were associated with the inappropriate prescription of direct oral anticoagulants.

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“…Overall, all included RCTs and most cohort studies reported low risks of bias. While Wakamatsu et al 23 (2020), Kwon et al 28 (2016), and Akagi et al 29 (2019) didn’t balance the confounding factors between groups, which had risks of comparability bias. Lee et al 25 (2018), Akagi et al 29 (2019), and Kohsaka et al 33 (2017) did not report the length of follow-up, and most cohort studies did not show the lost follow-up rate, which had risks of outcome bias.…”

Section: Resultsmentioning

confidence: 99%

Low-Dose NOACs Versus Standard-Dose NOACs or Warfarin on Efficacy and Safety in Asian Patients with NVAF: A Meta-Analysis

Li¹,

Zheng²,

Li³

et al. 2022

Anatolian J Cardiol

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Background: The meta-analysis of randomized controlled trials has illustrated that the efficacy of low-dose non-vitamin K antagonist oral anticoagulants is inferior compared with standard-dose non-vitamin K antagonist oral anticoagulants, though they are still frequently prescribed for Asian patients with non-valvular atrial fibrillation. We aimed to further investigate the efficacy and safety of low-dose non-vitamin K antagonist oral anticoagulants by carrying out a meta-analysis of all relevant randomized controlled trials and cohort studies. Methods: Cochrane Central Register of Controlled Trials, Embase, and MEDLINE were systematically searched from the inception to September 9, 2021, for randomized controlled trials or cohorts that compared the efficacy and/or safety of low-dose non-vitamin K antagonist oral anticoagulants in Asian patients with non-valvular atrial fibrillation. The primary outcomes were stroke and major bleeding, and the secondary outcomes were mortality, intracranial hemorrhage, and gastrointestinal hemorrhage. Hazard ratios and 95% CIs were estimated using the random-effect model. Results: Nineteen publications involving 371 574 Asian patients with non-valvular atrial fibrillation were included. Compared with standard-dose non-vitamin K antagonist oral anticoagulants, low-dose non-vitamin K antagonist oral anticoagulants showed comparable risks of stroke (hazard ratio, 1.18; 95% CI 0.98 to 1.42), major bleeding (hazard ratio, 1.00; 95% CI 0.83 to 1.21), intracranial hemorrhage (hazard ratio, 1.13; 95% CI 0.92 to 1.38), and gastrointestinal hemorrhage (hazard ratio, 1.07; 95% CI 0.87 to 1.31), though had a higher risk of mortality (hazard ratio, 1.34; 95% CI 1.05 to 1.71). Compared with warfarin, low-dose non-vitamin K antagonist oral anticoagulants were associated with lower risks of stroke (hazard ratio, 0.73; 95% CI 0.67 to 0.79), mortality (hazard ratio, 0.69; 95% CI 0.60 to 0.81), major bleeding (hazard ratio, 0.62; 95% CI 0.51 to 0.75), intracranial hemorrhage (hazard ratio, 0.48; 95% CI 0.33 to 0.69), and gastrointestinal hemorrhage (hazard ratio, 0.78; 95% CI 0.65 to 0.93). Conclusion: Low-dose non-vitamin K antagonist oral anticoagulants were superior to warfarin, and comparable to standard-dose non-vitamin K antagonist oral anticoagulants considering risks of stroke, major bleeding, intracranial hemorrhage, and gastrointestinal hemorrhage. Further, high qualified studies are warranted.

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Clinical Outcomes of Off-Label Underdosing of Direct Oral Anticoagulants After Ablation for Atrial Fibrillation

Cited by 11 publications

References 29 publications

Prescribing Errors With Direct Oral Anticoagulants and Their Impact on the Risk of Bleeding in Patients With Atrial Fibrillation

Prescribing Errors With Direct Oral Anticoagulants and Their Impact on the Risk of Bleeding in Patients With Atrial Fibrillation

PrevAleNce and Associated factors of inappropriaTe dosing of direct Oral anticoaguLants In pAtients with Atrial Fibrillation: the ANATOLIA-AF Study

Low-Dose NOACs Versus Standard-Dose NOACs or Warfarin on Efficacy and Safety in Asian Patients with NVAF: A Meta-Analysis

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