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

 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（由申请人提供）：心房颤动 (AF) 是一种常见的心律失常，影响超过 200 万美国人，并与发病率、死亡率和医疗费用增加相关。房颤的充分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（美国为华法林）来实现的。然而，华法林的使用很麻烦，并且存在显着的并发症风险。最近，随机试验证明新型口服抗凝剂（OAC；达比加群、利伐沙班、阿哌沙班）在预防 AF 患者中风方面至少与华法林一样有效。然而，随机试验并不总是能够推广到通常的临床环境。因此，有必要进行额外的研究来确定这些新 OAC 与华法林相比的有效性，并确定更有可能从新药物中受益的患者。在本申请中，我们建议评估以下具体目标：(1) 评估新 OAC 与华法林治疗在预防缺血性中风、全身性栓塞、医疗保健利用率和死亡率方面的有效性；(2) 评估在这些患者中使用新 OAC 与华法林相关的出血和其他并发症（心肌梗死、消化不良）的风险； (3) 确定按年龄、性别、种族/民族定义的患者亚组， 新 OAC 对这些疾病特别有益或有害的合并症和其他药物的使用； (4) 使用新的 OAC 开发和验证 AF 患者中风/心源性栓塞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：OptumInsight 和 MarketScan。这些数据库包括超过 100 万 AF 患者和超过 155,000 名新 OAC 用户的健康保险索赔。最先进的比较有效性研究方法，包括高维倾向评分、边际结构模型和工具变量，将用于调整混杂因素。我们的研究结果将提供关键证据，帮助患者和临床医生做出抗凝治疗决策，平衡不同治疗方案的益处和风险。该提案还有可能为监管机构、保险公司、卫生系统领导者和专业组织在上市后批准、报销和临床指南等问题上的决策提供信息。

项目成果

Oral anticoagulation therapy and subsequent risk of venous thromboembolism in atrial fibrillation patients.

• DOI: 10.1080/03007995.2018.1541445
• 发表时间: 2019-05
• 期刊: Current medical research and opinion
• 影响因子: 2.3
• 作者: Lutsey PL;Norby FL;Zakai NA;MacLehose RF;Chen LY;Shah S;Datta YH;Alonso A
• 通讯作者: Alonso A

Association of Type of Antidepressant Initiation with Bleeding Risk in Atrial Fibrillation Patients Taking Oral Anticoagulants.

• DOI: 10.1007/s40801-021-00258-3
• 发表时间: 2021-09
• 期刊: Drugs - real world outcomes
• 作者: Shao IY;Claxton JS;Lutsey PL;Chen LY;MacLehose RF;Alonso A
• 通讯作者: Alonso A

Impact of oral anticoagulation choice on healthcare utilization for the primary treatment of venous thromboembolism.

• DOI: 10.1177/1358863x20940388
• 发表时间: 2020-12
• 期刊: Vascular medicine (London, England)
• 作者: Lutsey PL;MacLehose RF;Claxton JS;Walker RF;Adam TJ;Alonso A;Zakai NA
• 通讯作者: Zakai NA

Predicting Atrial Fibrillation and Its Complications.

• DOI: 10.1253/circj.cj-16-0239
• 发表时间: 2016-04-25
• 期刊: Circulation journal : official journal of the Japanese Circulation Society
• 作者: Alonso A;Norby FL
• 通讯作者: Norby FL

Sex differences in treatment strategy and adverse outcomes among patients 75 and older with atrial fibrillation in the MarketScan database.

• DOI: 10.1186/s12872-021-02419-2
• 发表时间: 2021-12-16
• 期刊: BMC cardiovascular disorders
• 影响因子: 2.1
• 作者: Subramanya V;Claxton JS;Lutsey PL;MacLehose RF;Chen LY;Chamberlain AM;Norby FL;Alonso A
• 通讯作者: Alonso A