Comparison of the Effectiveness and Safety of Apixaban, Dabigatran, Rivaroxaban, and Warfarin in Newly Diagnosed Atrial Fibrillation

Hernandez, Inmaculada; Zhang, Yuting; Saba, Samir

doi:10.1016/j.amjcard.2017.07.092

Cited by 87 publications

(91 citation statements)

References 20 publications

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“…The mean age of our study population reflected other European studies on users of DOAC with NVAF, despite varying inclusion criteria . In line with other studies, we found that most of the users were older than 75 years, except in Mondriaan and DNR databases …”

Section: Discussionsupporting

confidence: 85%

Incidence of direct oral anticoagulant use in patients with nonvalvular atrial fibrillation and characteristics of users in 6 European countries (2008–2015): A cross‐national drug utilization study

Ibáñez

Sabaté

Vidal

et al. 2019

Brit J Clinical Pharma

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AimsTo estimate the incidence of direct oral anticoagulant drug (DOAC) use in patients with nonvalvular atrial fibrillation and to describe user and treatment characteristics in 8 European healthcare databases representing 6 European countries.MethodsLongitudinal drug utilization study from January 2008 to December 2015. A common protocol approach was applied. Annual period incidences and direct standardisation by age and sex were performed. Dose adjustment related to change in age and by renal function as well as concomitant use of potentially interacting drugs were assessed.ResultsA total of 186 405 new DOAC users (age ≥18 years) were identified. Standardized incidences varied from 1.93–2.60 and 0.11–8.71 users/10 000 (2011–2015) for dabigatran and rivaroxaban, respectively, and from 0.01–8.12 users/10 000 (2012–2015) for apixaban. In 2015, the DOAC incidence ranged from 9 to 28/10 000 inhabitants in SIDIAP (Spain) and DNR (Denmark) respectively. There were differences in population coverage among the databases. Only 1 database includes the total reference population (DNR) while others are considered a population representative sample (CPRD, BIFAP, SIDIAP, EGB, Mondriaan). They also varied in the type of drug data source (administrative, clinical). Dose adjustment ranged from 4.6% in BIFAP (Spain) to 15.6% in EGB (France). Concomitant use of interacting drugs varied between 16.4% (SIDIAP) and 70.5% (EGB). Cardiovascular comorbidities ranged from 25.4% in Mondriaan (The Netherlands) to 82.9% in AOK Nordwest (Germany).ConclusionOverall, apixaban and rivaroxaban increased its use during the study period while dabigatran decreased. There was variability in patient characteristics such as comorbidities, potentially interacting drugs and dose adjustment. (EMA/2015/27/PH).

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Section: Discussionsupporting

confidence: 85%

Incidence of direct oral anticoagulant use in patients with nonvalvular atrial fibrillation and characteristics of users in 6 European countries (2008–2015): A cross‐national drug utilization study

Ibáñez

Sabaté

Vidal

et al. 2019

Brit J Clinical Pharma

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“…However, other studies also reported bleeding risks to be higher among rivaroxaban patients than among patients using dabigatran , a finding that was observed for other bleeds but not gastrointestinal bleeding in our study; this could, however, be due to different definitions of bleeding being used. As in this study, several other studies reported no differences in bleeding events between apixaban and dabigatran ; most other studies also did not find any differences with regard to haemorrhagic stroke.…”

Section: Discussioncontrasting

confidence: 61%

“…Several previous studies have highlighted differences in bleeding risks between rivaroxaban and apixaban, with risks for gastrointestinal bleeding , other major bleeding and overall bleeding risks all significantly higher among rivaroxaban patients. However, other studies also reported bleeding risks to be higher among rivaroxaban patients than among patients using dabigatran , a finding that was observed for other bleeds but not gastrointestinal bleeding in our study; this could, however, be due to different definitions of bleeding being used. As in this study, several other studies reported no differences in bleeding events between apixaban and dabigatran ; most other studies also did not find any differences with regard to haemorrhagic stroke.…”

Section: Discussionmentioning

confidence: 99%

Comparative safety and effectiveness of direct oral anticoagulants in patients with atrial fibrillation in clinical practice in Scotland

Mueller

Alvarez-Madrazo

Robertson

et al. 2018

Brit J Clinical Pharma

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AimsThe aim of this study was to compare the clinical effectiveness and safety of direct oral anticoagulants (DOACs) in patients with atrial fibrillation (AF) in routine clinical practice.MethodsThis retrospective cohort study used linked administrative data. The study population (n = 14 577) included patients with a diagnosis of AF (confirmed in hospital) who initiated DOAC treatment in Scotland between August 2011 and December 2015. Multivariate Cox proportional hazard models were used to estimate hazard ratios of thromboembolic events, mortality and bleeding events.ResultsNo differences between the DOACs were observed with regard to the risk of stroke, systemic embolism or cardiovascular death. In contrast, the risk of myocardial infarction was higher among patients prescribed apixaban in comparison to those on rivaroxaban (HR 1.67, 95% CI 1.02‐2.71), and all‐cause mortality was higher among rivaroxaban patients in contrast to both apixaban (1.22 [1.01–1.47]) and dabigatran (1.55 [1.16–2.05]) patients; rivaroxaban patients also had a higher risk of pulmonary embolism than apixaban patients (5.27 [1.79–15.53]). The risk of other major bleeds was higher among rivaroxaban patients compared to apixaban (1.50 [1.10–2.03]) and dabigatran (1.58 [1.01–2.48]) patients; the risks of gastrointestinal bleeds and overall bleeding were higher among rivaroxaban patients than among apixaban patients (1.48 [1.01–2.16] and 1.52 [1.21–1.92], respectively).ConclusionsAll DOACs were similarly effective in preventing strokes and systemic embolisms, while patients being treated with rivaroxaban exhibited the highest bleeding risks. Observed differences in the risks of all‐cause mortality, myocardial infarction and pulmonary embolism warrant further research.

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“…Fourth, our study included Medicare beneficiaries newly diagnosed with AF in 2013–2014, and it is unknown how applicable our results will be to other populations. Finally, in defining outcomes, we followed previously published definitions and did not restrict the position of ICD‐9 codes for outcomes within the claims . For this reason, our definitions may have lower positive predictive values than definitions based solely on primary diagnosis codes .…”

Section: Discussionmentioning

confidence: 99%

“…Secondary outcomes included ischemic stroke, all‐cause mortality, and bleeding events other than GI and intracranial bleeding. Bleeding outcomes were defined using a previously published list of ICD‐9 codes . Following previously published definitions, we used inpatient and outpatient claims in defining these outcomes, and there was no restriction on the position of ICD‐9 codes for outcomes within the claims …”

Section: Methodsmentioning

confidence: 99%

Outcomes of Patients With Atrial Fibrillation Newly Recommended for Oral Anticoagulation Under the 2014 American Heart Association/American College of Cardiology/Heart Rhythm Society Guideline

Gray

Saba

Zhang

et al. 2018

JAHA

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BackgroundIn March 2014, the American Heart Association updated their guidelines for the management of oral anticoagulation (OAC) in atrial fibrillation, recommending OAC for all patients with CHA 2 DS 2‐VASc ≥2. Previously, only patients with CHADS 2 ≥2 were recommended for anticoagulation. This study compared effectiveness and safety outcomes of OAC among patients who would receive OAC using the 2014 guidelines but not the 2011 guidelines.Methods and ResultsUsing claims data from a 5% sample of 2013–2014 Medicare beneficiaries, we identified patients with initially diagnosed atrial fibrillation between 2013 and 2014 and selected those who would receive OAC under the 2014 guidelines but not the 2011 guidelines (those with CHA 2 DS 2‐VASc score ≥2 or CHADS 2 score <2). Patients were categorized according to their use of OAC after first atrial fibrillation diagnosis (2937 users and 2914 nonusers). Primary outcomes included the composite of ischemic stroke, systemic embolism and death, and any bleeding event. Cox proportional hazard models were constructed to compare the risk of primary outcomes between the 2 groups, while controlling for patient demographic and clinical characteristics. There was no difference in the combined risk of stroke, systemic embolism, and death between the treatment groups (hazard ratio, 1.00; 95% confidence interval, 0.84–1.20). The risk of bleeding was higher for patients receiving OAC than for patients not receiving OAC (hazard ratio, 1.70, 95% confidence interval, 1.46–1.97).ConclusionsThe benefit of OAC is not well defined in this patient population, and new studies that minimize residual confounding are needed to fully understand the risk/benefit of OAC in patients with atrial fibrillation and low to moderate stroke risk.

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Comparison of the Effectiveness and Safety of Apixaban, Dabigatran, Rivaroxaban, and Warfarin in Newly Diagnosed Atrial Fibrillation

Cited by 87 publications

References 20 publications

Incidence of direct oral anticoagulant use in patients with nonvalvular atrial fibrillation and characteristics of users in 6 European countries (2008–2015): A cross‐national drug utilization study

Incidence of direct oral anticoagulant use in patients with nonvalvular atrial fibrillation and characteristics of users in 6 European countries (2008–2015): A cross‐national drug utilization study

Comparative safety and effectiveness of direct oral anticoagulants in patients with atrial fibrillation in clinical practice in Scotland

Outcomes of Patients With Atrial Fibrillation Newly Recommended for Oral Anticoagulation Under the 2014 American Heart Association/American College of Cardiology/Heart Rhythm Society Guideline

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