Assessment of Apixaban Prescribing Patterns for Nonvalvular Atrial Fibrillation in Hospitalized Patients

Background: Apixaban is a direct oral anticoagulant (DOAC) for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF). Other DOACs require renal dose adjustments based solely on creatinine clearance. Apixaban differs in that its dose adjustments are more complex, potentially leading to prescribing errors. Objective: To determine if adherence to Food and Drug Administration (FDA)-approved dosing for apixaban is maintained in hospitalized patients with NVAF. Methods: Patients ≥18 years old with NVAF who received apixaban during admission to 1 of 3 hospitals were evaluated. The primary outcome was to determine if providers order apixaban in accordance with FDA-approved dosages. Secondary outcomes included determining if pharmacist review increased the number of orders in accordance with FDA-approved dosing, which of the 3 criteria (age ≥80 years, body weight ≤60 kg, or serum creatinine ≥1.5 mg/dL) were met in patients receiving off-label dosing, and the rationale for off-label prescribing. Results: A total of 556 patients met inclusion criteria. Apixaban was dosed according to FDA labeling by providers in 83.4% (n = 464) of orders. After pharmacist review, 87.0% (n = 484) of orders were at the approved dose, 12.2% (n = 68) were underdosed, and 0.7% (n = 4) were overdosed. Most patients who were underdosed met only 1 dose reduction criterion—most commonly age ≥80 years (56.0%). Reasons for off-label dosing included home dose continuation (39.0%), history of or perceived bleeding risk (30.5%), or unspecified/other (30.5%). Conclusions: The majority of apixaban orders for NVAF were based on FDA-approved dosages after provider entry and pharmacist review.

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Abstract 448: Association of CHADS2 and CHA2DS2-VASc Score with Coronary Atherosclerosis Burden in Nonvalvular Atrial Fibrillation

Arteriosclerosis Thrombosis and Vascular Biology ◽

10.1161/atvb.34.suppl_1.448 ◽

2014 ◽

Vol 34 (suppl_1) ◽

Author(s):

Kongkiat Chaikriangkrai ◽

Sama Alchalabi ◽

Sayf Khaleel bala ◽

Mahwash Kassi ◽

Su Min Chang

Keyword(s):

Atrial Fibrillation ◽

Coronary Artery ◽

Coronary Artery Calcium Score ◽

Cardiac Computed Tomography ◽

Calcium Score ◽

Operating Characteristics ◽

Nonvalvular Atrial Fibrillation ◽

Chads2 Score ◽

History Of ◽

Artery Disease

Background: This study is to examine association of CHADS2 and CHA2DS2-VASc score with coronary artery disease (CAD) in nonvalvular atrial fibrillation (AF) Method: A total of 676 consecutive nonvalvular AF patients without known history of CAD underwent coronary artery calcium score (CACS) evaluation by multi-detector cardiac computed tomography. Clinical characteristics and CACS were compared between different CHADS2 and CHA2DS2-VASc score groups. Results: The cohort comprised of 68% (461 of 676) male with a mean ± SD age of 63 ± 10 years. Median 10-year risk of CAD by Framingham score was 11% (range 2%-53%). Median CHADS2 score was 1 (range 0-6) and median CHA2DS2-VASc score was 2 (range 0-8). Mean ± SD CACS was 215 ± 504. Compared to CHADS2 score ≤ 1, those with CHADS2 score > 1 had higher mean ± SD CACS (359 ± 738 VS 158 ± 359; p<0.001). CHADS2 score > 1 is associated with CACS > 0 (OR 1.751; 95%CI 1.168, 2.624; p 0.007) and CACS > 400 (OR 2.528; 95%CI 1.641, 3.896; p < 0.001). Similarly, compared to CHA2DS2-VASc score ≤ 1, those with CHA2DS2-VASc score > 1 had higher mean ± SD CACS (270 ± 586 VS 150 ± 376; p<0.001). CHA2DS2-VASc score > 1 is associated with CACS > 0 (OR 1.713; 95%CI 1.217, 2.409; p 0.002) and CACS > 400 (OR 2.683; 95%CI 1.678, 4.289; p < 0.001). Receiver operating characteristics of CHADS2 and CHA2DS2-VASc score models for CACS > 400 is shown in the figure. Conclusion: In nonvalvular AF patients, higher CHADS2 and CHA2DS2-VASc score are comparably associated with presence and severity of CAD.

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Probable Rivaroxaban-Induced Full Body Rash: A Case Report

Journal of Pharmacy Practice ◽

10.1177/0897190017722872 ◽

2017 ◽

Vol 31 (5) ◽

pp. 503-506 ◽

Cited By ~ 3

Author(s):

Evan Sasson ◽

Marian James ◽

Mark Russell ◽

Darko Todorov ◽

Henry Cohen

Keyword(s):

Atrial Fibrillation ◽

Adverse Drug Events ◽

Factor Xa ◽

Similar Reaction ◽

Medication Regimen ◽

Nonvalvular Atrial Fibrillation ◽

Novel Oral Anticoagulant ◽

History Of ◽

Potential Issue ◽

Full Body

Introduction: Rivaroxaban is a novel oral anticoagulant with several indications, one of which is for stroke prevention in nonvalvular atrial fibrillation. We present a case of probable rivaroxaban-induced rash. Case Summary: A 79-year-old female with a medical history of atrial fibrillation experienced a stroke, after which she was prescribed rivaroxaban 20 mg. After several days, she developed a rash requiring admission to the emergency department and several days of treatment. The rash resolved and she was switched from rivaroxaban to apixaban and did not experience any adverse drug events. Discussion: Onset of symptoms occurred within days of rivaroxaban initiation. The patient had no allergy history and never reported a similar reaction while on concurrent home medication regimen. The resolution of rash and toleration of apixaban suggest a rivaroxaban-specific reaction. The mechanism of this rash is currently unclear. Conclusion: We report one of the first cases of probable rivaroxaban-induced rash, whereas the patient tolerated apixaban. Further investigation is warranted, but prescribers should be cognizant of this potential issue when choosing a factor Xa inhibitor for anticoagulation.

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Apixaban versus No Anticoagulation in Patients Undergoing Long-Term Dialysis with Incident Atrial Fibrillation

Clinical Journal of the American Society of Nephrology ◽

10.2215/cjn.11650919 ◽

2020 ◽

Vol 15 (8) ◽

pp. 1146-1154 ◽

Cited By ~ 3

Author(s):

Thomas A. Mavrakanas ◽

Katherine Garlo ◽

David M. Charytan

Keyword(s):

Atrial Fibrillation ◽

Confidence Interval ◽

Transient Ischemic Attack ◽

Lower Incidence ◽

Primary Outcome ◽

Hazard Ratio ◽

Intracranial Bleeding ◽

Nonvalvular Atrial Fibrillation ◽

Maintenance Dialysis ◽

Ischemic Attack

Background and objectivesThe relative efficacy and safety of apixaban compared with no anticoagulation have not been studied in patients on maintenance dialysis with atrial fibrillation. We aimed to determine whether apixaban is associated with better clinical outcomes compared with no anticoagulation in this population.Design, setting, participants, & measurementsThis retrospective cohort study used 2012–2015 US Renal Data System data. Patients on maintenance dialysis with incident, nonvalvular atrial fibrillation treated with apixaban (521 patients) were matched for relevant baseline characteristics with patients not treated with any anticoagulant agent (1561 patients) using a propensity score. The primary outcome was hospital admission for a new stroke (ischemic or hemorrhagic), transient ischemic attack, or systemic thromboembolism. The secondary outcome was fatal or intracranial bleeding. Competing risk survival models were used.ResultsCompared with no anticoagulation, apixaban was not associated with lower incidence of the primary outcome: hazard ratio, 1.24; 95% confidence interval, 0.69 to 2.23; P=0.47. A significantly higher incidence of fatal or intracranial bleeding was observed with apixaban compared with no treatment: hazard ratio, 2.74; 95% confidence interval, 1.37 to 5.47; P=0.004. A trend toward fewer ischemic but more hemorrhagic strokes was seen with apixaban compared with no treatment. No significant difference in the composite outcome of myocardial infarction or ischemic stroke was seen with apixaban compared with no treatment. Compared with no anticoagulation, a significantly higher rate of the primary outcome and a significantly higher incidence of fatal or intracranial bleeding and of hemorrhagic stroke were seen in the subgroup of patients treated with the standard apixaban dose (5 mg twice daily) but not in patients who received the reduced apixaban dose (2.5 mg twice daily).ConclusionsIn patients with kidney failure and nonvalvular atrial fibrillation, treatment with apixaban was not associated with a lower incidence of new stroke, transient ischemic attack, or systemic thromboembolism but was associated with a higher incidence of fatal or intracranial bleeding.PodcastThis article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2020_05_29_CJN11650919.mp3

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Rivaroxaban Versus Warfarin for Management of Obese African Americans With Non-Valvular Atrial Fibrillation or Venous Thromboembolism: A Retrospective Cohort Analysis

Clinical and Applied Thrombosis/Hemostasis ◽

10.1177/1076029620954910 ◽

2020 ◽

Vol 26 ◽

pp. 107602962095491

Author(s):

Olivia S. Costa ◽

Jan Beyer-Westendorf ◽

Veronica Ashton ◽

Dejan Milentijevic ◽

Kenneth Todd Moore ◽

...

Keyword(s):

Atrial Fibrillation ◽

Venous Thromboembolism ◽

African Americans ◽

Major Bleeding ◽

Cox Regression ◽

Cohort Analysis ◽

Bleeding Risk ◽

Nonvalvular Atrial Fibrillation ◽

Thrombotic Risk ◽

Hazard Ratios

African Americans (AAs) and obese individuals have increased thrombotic risk. This study evaluated the effectiveness and safety of rivaroxaban versus warfarin in obese, AAs with nonvalvular atrial fibrillation (NVAF) or venous thromboembolism (VTE). Optum® De-Identified Electronic Health Record (EHR) data was used to perform separate propensity-score matched analyses of adult, oral anticoagulant (OAC)-naïve AAs with NVAF or acute VTE, respectively; who had a body mass index≥30kg/m2 and ≥12-months EHR activity with ≥1-encounter before OAC initiation. Cox regression was performed and reported as hazard ratios (HRs) with 95% confidence intervals (CIs). For the NVAF analysis, 1,969 rivaroxaban- and 1,969 warfarin-users were matched. Rivaroxaban was not associated with a difference in stroke/systemic embolism versus warfarin (HR = 0.88, 95%CI = 0.60-1.28), but less major bleeding (HR = 0.68, 95%CI = 0.50-0.94) was observed. Among 683 rivaroxaban-users with VTE, 1:1 matched to warfarin-users, rivaroxaban did not alter recurrent VTE (HR = 1.36, 95%CI = 0.79-2.34) or major bleeding (HR = 0.80, 95%CI = 0.37-1.71) risk versus warfarin at 6-months (similar findings observed at 3- and 12-months). Rivaroxaban appeared to be associated with similar thrombotic, and similar or lower major bleeding risk versus warfarin in these obese, AA cohorts.

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Combination of Oral Anticoagulants and Single Antiplatelets versus Triple Therapy in Nonvalvular Atrial Fibrillation and Acute Coronary Syndrome: Stroke Prevention among Asians

International Journal of Angiology ◽

10.1055/s-0040-1708477 ◽

2020 ◽

Vol 29 (02) ◽

pp. 088-097

Author(s):

Anwar Santoso ◽

Sunu B. Raharjo

Keyword(s):

Atrial Fibrillation ◽

Acute Coronary Syndrome ◽

Triple Therapy ◽

Stroke Prevention ◽

Thrombus Formation ◽

Vitamin K Antagonists ◽

Oral Anticoagulants ◽

Bleeding Risk ◽

Nonvalvular Atrial Fibrillation ◽

Coronary Syndrome

AbstractAtrial fibrillation (AF), the most prevalent arrhythmic disease, tends to foster thrombus formation due to hemodynamic disturbances, leading to severe disabling and even fatal thromboembolic diseases. Meanwhile, patients with AF may also present with acute coronary syndrome (ACS) and coronary artery disease (CAD) requiring stenting, which creates a clinical dilemma considering that majority of such patients will likely receive oral anticoagulants (OACs) for stroke prevention and require additional double antiplatelet treatment (DAPT) to reduce recurrent cardiac events and in-stent thrombosis. In such cases, the gentle balance between bleeding risk and atherothromboembolic events needs to be carefully considered. Studies have shown that congestive heart failure, hypertension, age ≥ 75 years (doubled), diabetes mellitus, and previous stroke or transient ischemic attack (TIA; doubled)–vascular disease, age 65 to 74 years, sex category (female; CHA2DS2-VASc) scores outperform other scoring systems in Asian populations and that the hypertension, abnormal renal/liver function (1 point each), stroke, bleeding history or predisposition, labile international normalized ratio (INR), elderly (>65 years), drugs/alcohol concomitantly (1 point each; HAS-BLED) score, a simple clinical score that predicts bleeding risk in patients with AF, particularly among Asians, performs better than other bleeding scores. A high HAS-BLED score should not be used to rule out OAC treatment but should instead prompt clinicians to address correctable risk factors. Therefore, the current review attempted to analyze available data from patients with nonvalvular AF who underwent stenting for ACS or CAD and elaborate on the direct-acting oral anticoagulant (DOAC) and antiplatelet management among such patients. For majority of the patients, “triple therapy” comprising OAC, aspirin, and clopidogrel should be considered for 1 to 6 months following ACS. However, the optimal duration for “triple therapy” would depend on the patient's ischemic and bleeding risks, with DOACs being obviously safer than vitamin-K antagonists.

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Stroke prevention in atrial fibrillation: An Asian perspective

Thrombosis and Haemostasis ◽

10.1160/th13-11-0948 ◽

2014 ◽

Vol 111 (05) ◽

pp. 789-797 ◽

Cited By ~ 137

Author(s):

Kang-Ling Wang ◽

Gregory Y. H. Lip ◽

Chern-En Chiang

Keyword(s):

Atrial Fibrillation ◽

Stroke Prevention ◽

Oral Anticoagulants ◽

Bleeding Risk ◽

Risk Scores ◽

Asian Patients ◽

History Of ◽

Randomised Controlled ◽

Similar Risk ◽

Selection Of

SummaryAtrial fibrillation (AF) is the most common sustained cardiac arrhythmia. In 2050, it is estimated that there will be 72 million AF patients in Asia, accounting for almost 2.9 million patients suffering from AF-associated stroke. Asian AF patients share similar risk factor profiles as non-Asians, except that more Asians have a history of previous stroke. Clinical challenges are evident in the field of stroke prevention in AF, amongst Asians. Existing stroke and bleeding risk scores have not been well-validated in Asians. Asians are prone to bleeding when treated with warfarin, and the optimal international normalised ratio (INR) for warfarin use is yet to be determined in Asians, though Asian physicians tend to keep it in a lower range (e.g. INR 1.6–2.6) for elderly patients despite limited evidence to justify this. In general, warfarin is ‘difficult’ to use in Asians due to higher risk of bleeding and higher stroke rate in Asians than in non-Asians, as shown in randomised controlled trials. Excess of bleeding was not found in Asians when novel oral anticoagulants (NOACs) were used. Besides, the superiority of NOACs to warfarin in reducing thromboembolism was maintained in Asians. Therefore NOACs are preferentially indicated in Asians in terms of both efficacy and safety. Also, some preliminary data suggest that Asian patients with AF might not be the same. Future prospective randomised trials are needed for the selection of NOACs according to different ethnic background.Note: The review process for this manuscript was fully handled by Christian Weber, Editor in Chief.

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