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The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Cost-Effective Medicines for Stroke Prophylaxis in Patients with Atrial Fibrillation
Anjan K Chakrabarti1, Shalin J Patel1, Payal Kohli1
1Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center (AKC, SJP, LG, VK, CMG), Harvard Medical School, Boston, MA; TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women?s Hospital (PK, JAU), Harvard Medical School, Boston, MA; and the PERFUSE Angiographic Core Laboratories and Data Coordinating Center, Beth Israel Deaconess Medical Center (PS) in Boston, MA.
Insights
Newer antithrombotic agents for non-valvular atrial fibrillation, like dabigatran, offer cost-effective stroke prevention. These direct oral anticoagulants reduce bleeding and eliminate monitoring, improving patient outcomes and healthcare economics.
Area of Science:
- Cardiology
- Pharmacoeconomics
- Thrombosis Management
Background:
- Non-valvular atrial fibrillation (AF) is a common arrhythmia increasing stroke risk by 3-5 times.
- Traditional antithrombotic therapies include antiplatelet agents and vitamin K antagonists (VKAs).
- VKAs require costly therapeutic monitoring and have limitations in efficacy and safety.
Purpose of the Study:
- To evaluate the cost-effectiveness of newer antithrombotic agents compared to traditional therapies for AF.
- To assess the impact of direct thrombin and factor Xa inhibitors on thromboembolic events and bleeding risk.
- To analyze the economic benefits of eliminating routine monitoring for anticoagulation therapy.
Main Methods:
- Comparative analysis of clinical trial data and healthcare cost data.
- Pharmacoeconomic modeling to determine cost per quality-adjusted life-year (QALY) gained.
- Evaluation of stroke risk (e.g., CHADS2 score) and bleeding risk in patient subgroups.
Main Results:
- Dabigatran demonstrates cost-effectiveness compared to warfarin, with QALYs ranging from $16,385 to $86,000.
- Cost-effectiveness is particularly notable in high-risk stroke patients (CHADS2 > 3) and selected lower-risk patients.
- Factor Xa inhibitors like rivaroxaban and apixaban are anticipated to offer similar cost savings by reducing bleeding and monitoring needs.
Conclusions:
- Direct oral anticoagulants (DOACs) represent a cost-effective advancement in AF antithrombotic therapy.
- DOACs improve safety profiles by reducing bleeding and eliminating the need for intensive monitoring.
- Individualized patient assessment balancing stroke/bleeding risk and quality of life is crucial for optimal DOAC selection.
Abstract:
Non-valvular atrial fibrillation is the most common arrhythmia encountered in clinical practice and is associated with substantial healthcare costs. The risk of thromboembolic stroke is 3-5 times higher in patients with atrial fibrillation compared with the general population. Until the recent emergence of direct thrombin (factor IIa) and factor Xa inhibitors, antithrombotic therapy for atrial fibrillation was achieved with antiplatelet agents or vitamin K antagonists, which are considered cost-effective strategies when compared to no treatment. Now newer agents, such as the direct thrombin inhibitor dabigatran, can lower thromboembolic events and reduce the risk of fatal and intracerebral hemorrhage compared with warfarin, in addition to eliminating the need for costly therapeutic monitoring. Multiple analyses have shown that dabigatran, when compared with warfarin therapy that achieves a time in therapeutic range (TTR) consistent with previous large-scale trials, is a cost-effective approach to antithrombotic therapy in atrial fibrillation, ranging from $16,385 to $86,000 per quality-adjust life-year (QALY) gained. It has been shown to be especially cost-effective (QALY < $50,000) for high stroke-risk patients, those with a CHADS2 score of > 3 (barring excellent INR control) and for lower-risk patients with a CHADS2 of 2 but concomitant high risk of hemorrhage. In addition, factor Xa inhibitors, such as rivaroxaban (recently approved by the Federal Drug Administration [FDA]) and apixaban, may exhibit the same cost savings as dabigatran in terms of reduction of bleeding and elimination of therapeutic level monitoring costs. Going forward, the use of these agents and their role in thromboembolic stroke prophylaxis will need to be evaluated on a patient-by-patient basis, balancing consideration of the patient?s stroke and bleeding risks, as well as quality of life post-therapy.
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