Atrial fibrillation (AF), a common cardiac arrhythmia, affects >2 million Americans and is associated with increased morbidity, mortality, and healthcare costs. Adequate antithrombotic treatment in AF is critical to preventing stroke and other complications. To date, this has been mostly achieved with vitamin K antagonists (warfarin in the US). Warfarin use, however, is burdensome and carries a significant risk of complications. Recently, new oral anticoagulants (OACs; dabigatran, rivaroxaban, apixaban) have proved in randomized trials to be at least as efficacious as warfarin in preventing stroke in AF patients. Randomized trials, however, are not always generalizable to the usual clinical setting. Therefore, additional research is necessary to determine the effectiveness of these new OACs, compared to warfarin, and to identify patients more likely to benefit from the new medications. In this application, we propose to assess the following specific aims: (1) to estimate the effectiveness of new OACs versus warfarin treatment in the prevention of ischemic stroke, systemic embolism, healthcare utilization, and mortality;(2) to assess the risk of bleeding and other complications (myocardial infarction, dyspepsia) associated with use of new OACs versus warfarin in these patients; (3) to identify patient subgroups, defined by age, sex, race/ethnicity, comorbidities, and use of other medications, for which the new OACs are particularly beneficial or hazardous; and (4) to develop and validate risk predictive models of stroke / cardioembolic complications and severe hemorrhage in AF patients using new OACs. To address these research questions, we will use two large claim databases, OptumInsight and MarketScan. These databases include health insurance claims from over 1 million patients with AF, and >155,000 users of new OACs. State- of-the-art methods for comparative effectiveness research, including high-dimensional propensity scores, marginal structural models, and instrumental variables, will be used to adjust for confounding. Results from our research will provide key evidence to help patients and clinicians make decisions about their anticoagulant treatment, balancing benefits and risks associated with different therapeutic options. This proposal also has the potential to inform decisions by regulatory agencies, insurers, health system leaders, and professional organizations in issues such as post marketing approval, reimbursements, and clinical guidelines.
Limited information exists on the 'real-world' effectiveness of new oral anticoagulants compared to warfarin in the treatment of patients with atrial fibrillation,a common cardiac arrhythmia. The proposed research will provide timely and necessary information to help clinicians and patients make well-founded decisions on the use and choice of oral anticoagulants. Our project will complement information from published phase III randomized controlled trials of new oral anticoagulants.
|Alonso, Alvaro; MacLehose, Richard F; Chen, Lin Yee et al. (2018) Oral anticoagulants and liver injury: the threat of uncontrolled confounding. Heart 104:84|
|Shah, Surbhi; Norby, Faye L; Datta, Yvonne H et al. (2018) Comparative effectiveness of direct oral anticoagulants and warfarin in patients with cancer and atrial fibrillation. Blood Adv 2:200-209|
|O'Neal, Wesley T; Sandesara, Pratik B; Claxton, J'Neka S et al. (2018) Influence of Sociodemographic Factors and Provider Specialty on Anticoagulation Prescription Fill Patterns and Outcomes in Atrial Fibrillation. Am J Cardiol 122:388-394|
|Claxton, J'Neka S; MacLehose, Richard F; Lutsey, Pamela L et al. (2018) A New Model to Predict Ischemic Stroke in Patients with Atrial Fibrillation Using Warfarin or Direct Oral Anticoagulants. Heart Rhythm :|
|O'Neal, Wesley T; Claxton, J'Neka S; Sandesara, Pratik B et al. (2018) Provider Specialty, Anticoagulation, and Stroke Risk in Patients With Atrial Fibrillation and Cancer. J Am Coll Cardiol 72:1913-1922|
|Roetker, Nicholas S; Lutsey, Pamela L; Zakai, Neil A et al. (2018) All-Cause Mortality Risk with Direct Oral Anticoagulants and Warfarin in the Primary Treatment of Venous Thromboembolism. Thromb Haemost 118:1637-1645|
|Zakai, N A; Walker, R F; MacLehose, R F et al. (2018) Impact of anticoagulant choice on hospitalized bleeding risk when treating cancer-associated venous thromboembolism. J Thromb Haemost 16:2403-2412|
|Norby, Faye L; Alonso, Alvaro (2017) Comparative effectiveness of rivaroxaban in the treatment of nonvalvular atrial fibrillation. J Comp Eff Res 6:549-560|
|Bengtson, Lindsay G S; Lutsey, Pamela L; Chen, Lin Y et al. (2017) Comparative effectiveness of dabigatran and rivaroxaban versus warfarin for the treatment of non-valvular atrial fibrillation. J Cardiol 69:868-876|
|Alonso, Alvaro; Lutsey, Pamela L; Chen, Lin Y et al. (2017) Questions in the comparative effectiveness of dabigatran and warfarin in atrial fibrillation. J Cardiol 70:99-100|
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