Comparing Stroke and Bleeding with Rivaroxaban and Dabigatran in Atrial Fibrillation: Analysis of the US Medicare Part D Data

Hernandez, Inmaculada; Zhang, Yuting

doi:10.1007/s40256-016-0189-9

Cited by 53 publications

(43 citation statements)

References 26 publications

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“…Although underdosing of apixaban was associated with an increased risk of stroke, dabigatran 75mg and rivaroxaban 10mg/15mg use in patients without a renal indication was not associated with differences in stroke or major bleeding rates [16]. A sub-therapeutic effect may be plausible for low dose rivaroxaban in our study, with an ischemic stroke rate well in excess of previous studies [8–9, 32–34]. Although we did not have laboratory values to estimate renal function and determine if dosing was appropriate, ischemic stroke and bleeding rates were low (0 events) among low dose rivaroxaban users with diagnosed CRI.…”

Section: Discussioncontrasting

confidence: 44%

“…When used for secondary stroke prevention at standard doses, dabigatran and rivaroxaban have been reported to have similar risk for thromboembolic events, bleeding events, and all-cause mortality based upon indirect treatment comparisons using trial data [6–7]. Recent observational studies focused on patients treated for primary prevention have, however, suggested an increased risk of bleeding and mortality with rivaroxaban at both the renal (75mg dabigatran, 15mg rivaroxaban) and standard doses (150mg dabigatran, 20mg rivaroxaban) [8–9]. Single-center studies of DOACs post-stroke have described variability in recurrence risk and recurrent stroke volume for rivaroxaban, dabigatran, and apixaban [10–11].…”

Section: Introductionmentioning

confidence: 99%

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Dabigatran Versus Rivaroxaban for Secondary Stroke Prevention in Patients with Atrial Fibrillation Rehabilitated in Skilled Nursing Facilities

et al. 2018

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Background: Thromboembolic and bleeding risk are elevated in older patients with atrial fibrillation and prior stroke. We compared dabigatran versus rivaroxaban for secondary prevention in a national population after skilled nursing facility (SNF) discharge. Methods: Medicare fee-for-service beneficiaries aged ≥65 years with atrial fibrillation hospitalized for ischemic stroke (11/2011–10/2013) and subsequently admitted to a SNF were studied. Dabigatran (n=332) and rivaroxaban users (n=378) were compared in a retrospective, active comparator, new-user cohort. The index medication claim occurred within 120 days after hospital discharge and exposure continued until a 14-day treatment gap (“as treated”). The primary net clinical benefit outcome was the time to recurrent stroke, transient ischemic attack, intracranial hemorrhage, extracranial bleed, myocardial infarction, venous thromboembolism, or death. All-cause mortality was evaluated separately as a secondary outcome. Multivariable adjusted Cox models stratified by dosage estimated hazard ratios (aHR). Results: Among those receiving low dosages, the crude composite event rate was 40.4/100 person-years among dabigatran users and 33.7/100 person-years among rivaroxaban users. The composite outcome (aHR: 1.48; 95% Confidence Interval (CI): 0.87–2.51) and all-cause mortality (aHR: 1.67; 95%CI: 0.84–3.31) rates were higher among low dose dabigatran users. For those receiving standard doses, the crude composite event rates were 19.5/100 person-years for dabigatran users and 37.1/100 person-years for rivaroxaban users. Although no difference in mortality was observed, the composite outcome rate was lower among standard dose dabigatran users (aHR: 0.65; 95%CI: 0.36–1.15). Conclusions: In older adults treated with direct-acting oral anticoagulants after ischemic stroke, outcome rates varied considerably by drug and dosage.

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Section: Discussioncontrasting

confidence: 44%

Section: Introductionmentioning

confidence: 99%

Dabigatran Versus Rivaroxaban for Secondary Stroke Prevention in Patients with Atrial Fibrillation Rehabilitated in Skilled Nursing Facilities

et al. 2018

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“…In the fourth cohort of GARFIELD AF, more than 70% of AF patients are anticoagulated, with a growing proportion being initiated on NOAC therapy over warfarin (37%), and OAC use was associated with a 35% lower risk of death 77 . Other registry data have since been published for comparative effectiveness and safety data for dabigatran, rivaroxaban, apixaban, and warfarin 50, 78, 79 .…”

Section: How Do Clinical Trial Results Compare With “Real World Data”?mentioning

confidence: 99%

Recent advances in the understanding and management of atrial fibrillation: a focus on stroke prevention

2016

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Atrial fibrillation (AF) is associated with an increased risk of stroke compared with the general population. It is anticipated that by 2030 an estimated 14–17 million patients will be diagnosed with this most prevalent arrhythmia within the European Union. AF-related stroke confers a higher mortality and morbidity risk, and thus early detection and assessment for the initiation of effective stroke prevention with oral anticoagulation (OAC) is crucial. Recent guidelines point to the use of non-vitamin K antagonist OACs (NOACs) where appropriate in stroke prevention of patients with non-valvular AF. At present, there are four NOACS available, with no direct head-to-head comparisons to suggest the superiority of one drug over another. Simple and practical risk assessment tools have evolved over the years to facilitate stroke and bleeding risk assessment in busy clinics and wards to aid decision-making. At present, the CHA 2DS 2VASc (congestive heart failure, hypertension, age 65–74/>75, diabetes mellitus, stroke/transient ischemic attack/thromboembolism, vascular disease, female sex) score is recommended by many international guidelines as a simple and practical method of assessing stroke risk in such patients. Alongside this, use of the HAS BLED (hypertension systolic blood pressure >160 mmHg, abnormal liver/renal function [with creatinine ≥200 μmol/L], stroke, bleeding history or predisposition, labile international normalized ratio [range <60% of the time], elderly [>65], concomitant drugs/alcohol) score aims to identify patients at high risk of bleeding for more regular review and follow-up and draws attention to potentially reversible bleeding risk factors. The aim of this review article is to provide an overview of recent advances in the understanding and management of AF with a focus on stroke prevention.

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“…Подобные закономерности были выявлены и в другом анализе пациентов Medicare, проведенном I. Hernandez и Y. Zhang [11]. В данном исследовании при среднем периоде наблюдения около 1 года у пациентов, получавших дабигатран в дозе 150 мг 2 раза/сут.…”

Section: Expert Board Resolutionunclassified

Concerning the Safety of the Direct Oral Anticoagulants in Routine Care

Резолюция¹

2017

Russ J Cardiol

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Comparing Stroke and Bleeding with Rivaroxaban and Dabigatran in Atrial Fibrillation: Analysis of the US Medicare Part D Data

Abstract: There was no difference in stroke prevention between rivaroxaban and dabigatran; however, rivaroxaban was associated with a higher risk of thromboembolic events other than stroke, death, and bleeding.

Cited by 53 publications

References 26 publications

Dabigatran Versus Rivaroxaban for Secondary Stroke Prevention in Patients with Atrial Fibrillation Rehabilitated in Skilled Nursing Facilities

Dabigatran Versus Rivaroxaban for Secondary Stroke Prevention in Patients with Atrial Fibrillation Rehabilitated in Skilled Nursing Facilities

Recent advances in the understanding and management of atrial fibrillation: a focus on stroke prevention

Concerning the Safety of the Direct Oral Anticoagulants in Routine Care

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