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

2020 ◽  
Vol 61 (6) ◽  
pp. 1165-1173
Author(s):  
Yuji Wakamatsu ◽  
Koichi Nagashima ◽  
Ryuta Watanabe ◽  
Masaru Arai ◽  
Katsuaki Yokoyama ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Outcomes ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Off Label

scholarly journals Impacts of off-label dosing noacs on clinical outcomes in very elderly patients with atrial fibrillation

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
T Chao ◽  
Y.H Chan ◽  
G.Y.H Lip ◽  
S.A Chen
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Outcomes ◽  
Major Bleeding ◽  
Lower Risk ◽  
Oral Anticoagulants ◽  
Systemic Embolism ◽  
Very Elderly ◽  
Off Label ◽  
Funding Sources ◽  
Clinical Events

Abstract Background Studies about the comparisons of on-label and off-label dosing non-vitamin K antagonist oral anticoagulants (NOACs) regarding the risks of clinical outcomes among atrial fibrillation (AF) patients have been published. However, data among the very elderly AF patients were limited. In the present study, we aimed to investigate the impacts of inappropriate dosing of NOACs on clinical outcomes in AF patients aged ≥85 years of age. Methods We used medical data from a multi-center healthcare system in Taiwan enrolling 1,836 and 268 AF patients aged ≥85 years treated with NOACs and warfarin, respectively. Among 1,836 patients receiving NOACs, underdosing, overdosing and on-label dosing NOACs were prescribed in 248, 149 and 1439 patients, respectively. The risks of ischemic stroke/systemic embolism (IS/SE) and major bleeding were compared between warfarin and NOACs in different dosing groups. Also, the risks of clinical events of underdosing and overdosing NOACs were comapred to on-labeling dosing. Results Compared to warfarin, underdosing NOACs were associated with a higher risk of IS/SE (aHR 2.39; p=0.048) without a lower risk of major bleeding; while overdosing NOACs were not associated with a lower risk of IS/SE (aHR 0.74, p=0.604) (Figure 1). Compared to on-label dosing NOACs, underdosing NOACs were associated with a higher risk of IS/SE, while the risk was not lower for overdoing NOACs (Figure 2). Conclusions Even for very elderly AF patients aged ≥85 years, NOACs should still be prescribed at the dosing following the criteria defined in clinical trials and guideline recommendations. FUNDunding Acknowledgement Type of funding sources: None. Figure 1 Figure 2

P1898Prevalence and risk of DOACs inappropriate dosing in atrial fibrillation. An analysis of the Swiss-AF and BEAT-AF registries

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
G Montrasio ◽  
M Coslovsky ◽  
A Wiencierz ◽  
C Baumgartner ◽  
N Rodondi ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Renal Function ◽  
Clinical Outcomes ◽  
Antiplatelet Therapy ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Bleeding Event ◽  
Bleeding Events ◽  
Off Label ◽  
Kaplan Meier

Abstract Background Direct oral anticoagulants (DOACs) have a similar efficacy in terms of stroke and mortality reduction as compared to Vitamin K-Antagonists (VKAs) and improved safety with regards to intracranial haemorrhage in patients with non-valvular atrial fibrillation (AF). Dose of DOACs needs to be adjusted according to age, weight, renal function and concomitant medication. Yet, off-label dosages have been reported in 11 - 45% of patients (on average 20%). Purpose To assess the prevalence of inappropriate DOAC-dosing according to the official prescribing information in two large prospective Swiss AF cohorts (Swiss-AF and BEAT-AF) and to evaluate its correlation with adverse clinical outcomes. Methods All 3267 patients taking oral anticoagulants were stratified at baseline as receiving DOACs (adequately dosed, under- or overdosed) or VKAs. Appropriateness of DOAC dosing was assessed based on age (≥80 years), weight (≤60kg) and renal function (serum creatinine ≥133μmol/l [apixaban]; creatinine clearence ≤50ml/min [all other DOACs]). Clinical outcomes were collected during a median follow-up of 2.96 years. Major adverse clinical events (MACE) consisted of a combination of myocardial infarction, cardiac death, ischemic stroke and systemic embolism. Safety was assessed by occurrence of any bleeding event. Results 1902 patients (58%) were on VKAs and 1365 on DOACs (42%). In the DOAC group, 1149 patients received a dose consistent with drug labelling (84%), 133 (10%) received an inappropriately high and 83 (6%) an inappropriately low dose. Overdosed patients were older than those adequately treated and more likely female, had a lower BMI and a higher CHA2DS2-VASc score (4 vs. 3 points) (p<0.001 for all). Underdosed patients were more likely to have concomitant antiplatelet therapy (p<0.001). Both off-label groups were more likely to have a history of coronary artery disease, heart failure and chronic kidney disease (p<0.001). Kaplan-Meier cumulative incidence rates for the first occurrence of MACE or bleedings are provided in Figure 1. Overdosed patients had an almost two-fold higher risk of bleeding (9.0 vs. 5.0 events per 100 patient-years compared to correctly dosed DOACs and to VKAs) and a higher rate of MACE (5.1 vs. 2.3 events per 100 patient years compared to correctly dosed DOACs and 5.1 vs. 3.4 compared to VKAs). Underdosing did not seem to be associated with a relevant increase in ischemic or bleeding events as compared to correctly dosed DOACs and VKAs (see Figure 1). Figure 1. Kaplan-Meier incidence curves Conclusion Inadequate DOACs dosing was found in 1 in 6 patients and correlated with a higher burden of comorbidities at baseline. Underdosing correlated with concomitant antiplatelet therapy. Overdosing was associated with adverse clinical outcome for ischemic and bleeding events.

Off-label dosing of non–vitamin K antagonist oral anticoagulants and clinical outcomes in Asian patients with atrial fibrillation

Heart Rhythm ◽  
2020 ◽  
Vol 17 (12) ◽  
pp. 2102-2110
Author(s):  
Yi-Hsin Chan ◽  
Tze-Fan Chao ◽  
Shao-Wei Chen ◽  
Hsin-Fu Lee ◽  
Yung-Hsin Yeh ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Outcomes ◽  
Vitamin K ◽  
Oral Anticoagulants ◽  
Vitamin K Antagonist ◽  
Off Label ◽  
Asian Patients

scholarly journals Label Adherence of Direct Oral Anticoagulants Dosing and Clinical Outcomes in Patients With Atrial Fibrillation

2020 ◽  
Vol 9 (12) ◽  
Author(s):  
Hee Tae Yu ◽  
Pil‐Sung Yang ◽  
Eunsun Jang ◽  
Tae‐Hoon Kim ◽  
Jae‐Sun Uhm ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Outcomes ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants

scholarly journals Long‐Term Medication Adherence Trajectories to Direct Oral Anticoagulants and Clinical Outcomes in Patients With Atrial Fibrillation

2021 ◽  
Author(s):  
Jaejin An ◽  
Zoe Bider ◽  
Tiffany Q. Luong ◽  
T. Craig Cheetham ◽  
Daniel T. Lang ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Medication Adherence ◽  
Clinical Outcomes ◽  
Rate Ratio ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Adherence Rate ◽  
Nonvalvular Atrial Fibrillation ◽  
Early Discontinuation

Background Direct oral anticoagulants (DOACs) are widely used in patients with nonvalvular atrial fibrillation for stroke prevention. However, long‐term adherence to DOACs and clinical outcomes in real‐world clinical practice is not well understood. This study evaluated long‐term medication adherence patterns to DOAC therapy and clinical outcomes in a large US integrated health care system. Methods and Results We included adult patients with nonvalvular atrial fibrillation who newly initiated DOACs between 2012 and 2018 in Kaiser Permanente Southern California. Long‐term (3.5 years) adherence trajectories to DOAC were investigated using monthly proportion of days covered and group‐based trajectory models. Factors associated with long‐term adherence trajectories were investigated. Multivariable Poisson regression analyses were used to investigate thromboembolism and major bleeding events associated with long‐term adherence trajectories. Of 18 920 patients newly initiating DOACs, we identified 3 DOAC adherence trajectories: consistently adherent (85.2%), early discontinuation within 6 months (10.6%), and gradually declining adherence (4.2%). Predictors such as lower CHA 2 DS 2 ‐VASc (0–1 versus ≥5) and previous injurious falls were associated with both early discontinuation and gradually declining adherence trajectories. Early discontinuation of DOAC therapy was associated with a higher risk of thromboembolism (rate ratio, 1.40; 95% CI, 1.05–1.86) especially after 12 months from DOAC initiation but a lower risk of major bleed compared with consistent adherence (rate ratio, 0.48; 95% CI, 0.30–0.75), specifically during the first 12 months following DOAC initiation. A gradual decline in adherence to DOACs was not statistically significantly associated with thromboembolism outcomes compared with consistent adherence. Conclusions Although a large proportion of patients with nonvalvular atrial fibrillation were adherent to DOAC therapy over 3.5 years, early discontinuation of DOAC was associated a higher risk of thromboembolic events. Future tailored interventions for early discontinuers may improve clinical outcomes.

Sign in / Sign up

Export Citation Format

Share Document