Prescribing and Safety of Direct-Acting Oral Anticoagulants Compared to Warfarin in Patients with Atrial Fibrillation on Chronic Hemodialysis

ESRD patients receiving hemodialysis (HD) were excluded from landmark trials evaluating direct-acting oral anticoagulants (DOACs) in atrial fibrillation (AF). The objective was to evaluate prescribing and bleeding with DOACs compared to warfarin in AF patients with chronic HD. A retrospective, observational study of patients receiving warfarin or DOAC from April 2010-April 2016 from area health system hospitals and Dialysis Clinics, Inc. records. Data was analyzed using descriptive statistics, ANOVA, and chi-square. Ninety-one patients were included with warfarin as the initial OAC in most patients (n = 76) at average dose of 29 mg/week. Fifteen patients were initially prescribed apixaban (n = 12) or dabigatran (n = 3). Most switches in OAC therapy were to apixaban. When the initial OAC was a DOAC, it was not dosed appropriately in five with one bleed, two dosed appropriately had bleeds. When initial warfarin was switched to a DOAC, it was not dosed appropriately in seven with five bleeds. More bleeds occurred with warfarin alone (n = 18) vs. those on warfarin switched to DOAC (n = 5) vs. DOAC alone (n = 3), p = 0.022. All but four patients that bled had HAS-BLED scores three or higher. Warfarin was most often prescribed and associated with a higher incidence of bleeding compared to DOACs in this population of patients at high risk for bleeding. Larger studies should be conducted to analyze the impact of DOAC dose appropriateness on safety and clinical outcomes.

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Impact of weight on the efficacy and safety of direct-acting oral anticoagulants in patients with non-valvular atrial fibrillation: a meta-analysis

EP Europace ◽

10.1093/europace/euz361 ◽

2020 ◽

Vol 22 (3) ◽

pp. 361-367 ◽

Cited By ~ 3

Author(s):

Aaqib H Malik ◽

Srikanth Yandrapalli ◽

Suchith Shetty ◽

Wilbert S Aronow ◽

Diwakar Jain ◽

...

Keyword(s):

Atrial Fibrillation ◽

Major Bleeding ◽

Oral Anticoagulants ◽

Outcome Data ◽

Phase Iii ◽

Safety And Efficacy ◽

Low Bmi ◽

Direct Acting ◽

The Impact ◽

Direct Acting Oral Anticoagulants

Abstract Aims This study sought to determine the impact of weight and body mass index (BMI) on the safety and efficacy of direct-acting oral anticoagulants (DOACs) compared with warfarin in patients with non-valvular atrial fibrillation. Methods and results A systematic literature search was employed in PubMed, Embase, and Cochrane clinical trials with no language or date restrictions. Randomized trials or their substudies were assessed for relevant outcome data for efficacy that included stroke or systemic embolization (SSE), and safety including major bleeding and all-cause mortality. Binary outcome data and odds ratios from the relevant articles were used to calculate the pooled relative risk. For SSE, the data from the four Phase III trials showed that DOACs are better or similarly effective with low BMI 0.73 (0.56–0.97), normal BMI 0.72 (0.58–0.91), overweight 0.87 (0.76–0.99), and obese 0.87 (0.76–1.00). The risk of major bleeding was also better or similar with DOACs in all BMI subgroups with low BMI 0.62 (0.37–1.05), normal BMI 0.72 (0.58–0.90), overweight 0.83 (0.71–0.96), and obese 0.91 (0.81–1.03). There was no impact on mortality in all the subgroups. In a meta-regression analysis, the effect size advantage of DOACs compared with warfarin in terms of safety and efficacy gradually attenuated with increasing weight. Conclusion Our findings suggest that a weight-based dosage adjustment may be necessary to achieve optimal benefits of DOACs for thromboembolic prevention in these patients with non-valvular atrial fibrillation. Further dedicated trials are needed to confirm these findings. PROSPERO 2019 CRD42019140693. Available from: https://www.crd.york.ac.uk/prospero/display_record.php? ID=CRD42019140693.

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Cardiovascular Pharmacotherapies Focus: Are low doses of direct-acting oral anticoagulants justified and appropriate in patients with nonvalvular atrial fibrillation?

European Cardiology Review ◽

10.15420/ecr.2016:11.2:ed2 ◽

2016 ◽

Vol 11 (2) ◽

pp. 115-117 ◽

Cited By ~ 1

Author(s):

Antoni Martínez-Rubio ◽

Gheorghe-Andrei Dan

Keyword(s):

Atrial Fibrillation ◽

Oral Anticoagulants ◽

Low Doses ◽

Nonvalvular Atrial Fibrillation ◽

Direct Acting ◽

Direct Acting Oral Anticoagulants

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Efficacy and Safety of Direct Oral Anticoagulants for Atrial Fibrillation Across Body Mass Index Categories

Journal of the American Heart Association ◽

10.1161/jaha.120.017383 ◽

2020 ◽

Vol 9 (24) ◽

Author(s):

Rachel M. Kaplan ◽

Yoshihiro Tanaka ◽

Rod S. Passman ◽

Michelle Fine ◽

Laura J. Rasmussen‐Torvik ◽

...

Keyword(s):

Atrial Fibrillation ◽

Body Mass Index ◽

Body Mass ◽

Intracranial Hemorrhage ◽

Oral Anticoagulants ◽

Efficacy And Safety ◽

Class 1 ◽

Direct Acting ◽

Direct Acting Oral Anticoagulants

Background Direct‐acting oral anticoagulants are now the preferred method of anticoagulation in patients with atrial fibrillation. Limited data on efficacy and safety of these fixed‐dose regimens are available in severe obesity where drug pharmacokinetics and pharmacodynamics may be altered. The objectives of this study were to evaluate efficacy and safety in patients with atrial fibrillation taking direct‐acting oral anticoagulants across body mass index (BMI) categories in a contemporary, real‐world population. Methods and Results We performed a retrospective study of patients with atrial fibrillation at an integrated multisite healthcare system. Patients receiving a direct‐acting oral anticoagulant prescription and ≥12 months of follow‐up between 2010 and 2017 were included. The primary efficacy and safety outcomes were ischemic stroke or systemic embolism and intracranial hemorrhage. We performed Cox proportional hazards modeling to compute hazard ratios (HRs) adjusted for CHA 2 DS 2 ‐VASc score to examine differences by excess BMI categories relative to normal BMI. Of 7642 patients, mean±SD age was 69±12 years with a median (interquartile range) follow‐up of 3.8 (2.2–6.0) years. Approximately 22% had class 1 obesity and 19% had class 2 or 3 obesity. Stroke risks were similar in patients with and without obesity (HR, 1.2; 95% CI, 0.5–2.9; and HR, 0.68; 95% CI, 0.23–2.0 for class 1 and class 2 or 3 obesity compared with normal BMI, respectively). Risk of intracranial hemorrhage was also similar in class 1 and class 2 or 3 obesity compared with normal BMI (HR, 0.64; 95% CI, 0.35–1.2; and HR, 0.66; 95% CI, 0.35–1.2, respectively). Conclusions Direct‐acting oral anticoagulants demonstrated similar efficacy and safety across all BMI categories, even at high weight values.

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