Comparative Effectiveness of Oral Anticoagulants in Atrial Fibrillation

口服抗凝药治疗心房颤动的疗效比较

• 批准号: 9233180
• 负责人: Alvaro Alonso
• 金额: $ 22.86万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-04-01 至 2019-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9233180
• 关键词: Address; Affect; Age; American; Anticoagulant therapy; Anticoagulants; Antithrombin III; Arrhythmia; Atrial Fibrillation; Benefits and Risks; Characteristics; Clinical; Comorbidity; Complement; Data; Databases; Decision Making; Dyspepsia; Effectiveness; Eligibility Determination; Embolism; Equilibrium; Ethnic Origin; European; Food Interactions; Guidelines; Health Care Costs; Health Insurance; Health system; Hemorrhage; Incidence; Individual; Institute of Medicine (U.S.); Insurance Carriers; Ischemic Stroke; Machine Learning; Marketing; Medicine; Methods; Modeling; Monitor; Morbidity - disease rate; Myocardial Infarction; National Heart, Lung, and Blood Institute; Oral; Patients; Pharmaceutical Preparations; Phase; Prevention; Professional Organizations; Publishing; Race; Randomized Controlled Trials; Research; Risk; Safety; Stroke; Stroke prevention; Structural Models; Subgroup; Therapeutic; Thrombin; Time; United States Food and Drug Administration; Vitamin K; Warfarin; base; comparative effectiveness; effectiveness research; head-to-head comparison; health care service utilization; high dimensionality; individual patient; inhibitor/antagonist; mortality; multidisciplinary; novel; novel therapeutics; power analysis; predictive modeling; prevent; public health relevance; randomized trial; sex; technique development; Address; Affect; Age; American; Anticoagulant therapy; Anticoagulants; Antithrombin III; Arrhythmia; Atrial Fibrillation; Benefits and Risks; Characteristics; Clinical; Comorbidity; Complement; Data; Databases; Decision Making; Dyspepsia; Effectiveness; Eligibility Determination; Embolism; Equilibrium; Ethnic Origin; European; Food Interactions; Guidelines; Health Care Costs; Health Insurance; Health system; Hemorrhage; Incidence; Individual; Institute of Medicine (U.S.); Insurance Carriers; Ischemic Stroke; Machine Learning; Marketing; Medicine; Methods; Modeling; Monitor; Morbidity - disease rate; Myocardial Infarction; National Heart, Lung, and Blood Institute; Oral; Patients; Pharmaceutical Preparations; Phase; Prevention; Professional Organizations; Publishing; Race; Randomized Controlled Trials; Research; Risk; Safety; Stroke; Stroke prevention; Structural Models; Subgroup; Therapeutic; Thrombin; Time; United States Food and Drug Administration; Vitamin K; Warfarin; base; comparative effectiveness; effectiveness research; head-to-head comparison; health care service utilization; high dimensionality; individual patient; inhibitor/antagonist; mortality; multidisciplinary; novel; novel therapeutics; power analysis; predictive modeling; prevent; public health relevance; randomized trial; sex; technique development

 DESCRIPTION (provided by applicant): 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.

 描述（由适用提供）：心律不齐的房颤（AF）影响> 200万美国人，并且与发病率，死亡率和医疗保健成本的增加有关。 AF中的足够的抗血栓治疗对于预防中风和其他并发症至关重要。迄今为止，这主要是通过维生素K拮抗剂（美国的华法林）实现的。然而，华法林的使用是朴素的，并具有并发症的重大风险。最近，在随机试验中已证明了新的口服抗凝剂（OACS； Dabigatran，Rivaroxaban，apixaban）至少与华法林一样有效，可以预防AF患者中风。但是，随机试验并不总是可以推广到通常的临床环境。因此，与华法林相比，必须进行进一步的研究，以确定这些新OAC的有效性，并确定患者从新药物中受益的可能性更大。在此应用中，我们建议评估以下具体目的：（1）估计新的OAC与华法林治疗在预防缺血性中风，全身性栓塞，医疗保健利用和死亡率方面的有效性；（2）评估与新复杂性和其他复杂性（Mycardial nspepsia）相关的狂欢的风险，这些疾病与这些狂热相关的狂欢群体与这些新OEF有关） （3）确定由年龄，性别，种族/种族定义的患者亚组， 新OAC特别有益或危险的合并症和其他药物的使用； （4）使用新OAC开发和验证AF患者的中风 /心脏并发症和严重出血的风险预测模型。为了解决这些研究问题，我们将使用两个大型索赔数据库，即optuminsight和MarketScan。这些数据库包括来自100万AF患者的健康保险索赔，新OAC的用户> 155,000名。比较有效性研究的最先进方法，包括高维倾向得分，边际结构模型和仪器变量，将用于调整混淆。我们研究的结果将提供关键证据，以帮助患者和临床医生就其抗凝治疗，平衡与不同治疗选择相关的风险做出决定。该提案还有可能在营销后批准，报销和临床准则等问题上为监管机构，确保机构，卫生系统领导者和专业组织的决策提供信息。