EPIDEMIOLOGY OF ANTICOAGULATION IN ATRIAL FIBRILLATION

心房颤动抗凝治疗的流行病学

• 批准号: 6055478
• 负责人: DANIEL EDWIN SINGER
• 金额: $ 70.99万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-09-30 至 2001-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6055478
• 关键词: anticoagulants; atrial fibrillation; cardiovascular disorder epidemiology; chemoprevention; clinical research; drug screening /evaluation; heart disorder chemotherapy; human data; human therapy evaluation

DESCRIPTION: (Adapted from Investigator's Abstract) Atrial fibrillation (AF) affects 4% of people over age 60, and it is also the most potent risk factor for stroke (relative risk of 5); 15% of all stroke, including >30% in those age >80, is attributable to AF. Seven randomized trials (RCTs) have shown anticoagulation can safely remove nearly all the risk of stroke due to AF. Nonetheless, only 1/3 of patients with AF are treated with anticoagulants, including only 19% of those age >80. Physicians are concerned about warfarin's safety in usual practice, particularly among the elderly, and about the burdens of monitoring anticoagulation. Concerns about risk of hemorrhage are supported by some observational studies of clinical practice, and by one RCT (SPAF II). As a result, several recent guidelines have suggested aspirin be used in the elderly, although evidence for its efficacy in AF is weak. The current application is designed to provide a rich source of information about anticoagulation for AF in 'real world' practice to optimally translate the efficacy seen in the RCTs into usual clinical care. It will also provide a resource for assessing genetic markers of risk of stroke in AF. The investigators will assemble two large cohorts: 1. the 8000 outpatients with AF in Kaiser Permanente of Northern CA; and 2. the 2500 patients managed by the Mass. General Hospital Anticoagulant Therapy Unit. Follow-up of these cohorts will address two important, linked topics, as follow: 1. specifying in clinical practice the rates of stroke and hemorrhage among patients with AF both on and off anticoagulants; and 2. identifying strategies to optimize control of anticoagulation. In detail, the research will provide the following: 1. precise and generalizable estimates of the rates of major bleeding of AF patients on warfarin in clinical care; 2. clinical risk factors for major bleeding, in particular assessing older age; 3. precise estimates of the rates of thromboembolism (TE) among AF patients not on anticoagulants; 4. clinical risk factors for TE with AF; 5. assessment of a novel marker of thrombosis risk -- the factor V Leiden gene mutation; 6. estimates of the optimal intensity of anticoagulation for AF; 7. identification of determinants of poor control of anticoagulation; 8. identification of correlates of the use of anticoagulation in AF; and 9. comparison of the quality of anticoagulation provided by anticoagulation units versus that of primary physicians. The investigators state that this research should lead to important health and economic benefits for older Americans.

描述：（改编自研究者摘要）心房颤动 (AF) 影响 4% 的 60 岁以上人群，也是最严重的风险 中风因素（相对风险为 5）；占所有中风的 15%，其中 >30% 年龄>80岁的人可归因于房颤。 七项随机试验 (RCT) 研究表明，抗凝治疗可以安全地消除几乎所有因以下原因引起的中风风险： AF。 尽管如此，只有 1/3 的 AF 患者接受了治疗 抗凝剂，仅占 80 岁以上人群的 19%。 医生是 担心华法林在日常实践中的安全性，特别是在 老年人，以及抗凝监测的负担。 担忧 关于出血风险的一些观察性研究支持 临床实践，以及一项随机对照试验 (SPAF II)。 结果，最近的几 指南建议老年人使用阿司匹林，尽管有证据表明 因为它对 AF 的疗效较弱。 当前的应用程序旨在提供丰富的信息源 关于“现实世界”实践中房颤抗凝治疗的最佳转化 随机对照试验中观察到的对常规临床护理的疗效。 它还将 为评估 AF 中风风险的遗传标记提供资源。 研究人员将聚集两个大队列： 1. 8000 名门诊患者 与北加州 Kaiser Permanente 的 AF 合作； 2. 2500 名患者 由麻省总医院抗凝治疗科管理。 这些群体的后续行动将涉及两个重要的、相互关联的主题，例如 遵循： 1. 在临床实践中明确卒中发生率和 AF 患者在使用和停用抗凝剂期间发生出血；和 2. 确定优化抗凝控制的策略。 详细， 研究将提供以下内容： 1. 精确且可概括 服用华法林的 AF 患者大出血发生率的估计 临床护理； 2.大出血的临床危险因素，特别是 评估老年； 3. 血栓栓塞发生率的精确估计 (TE) 未服用抗凝剂的 AF 患者； 4. 临床危险因素 TE 与 AF； 5. 评估血栓形成风险的新标志物—— 因子 V Leiden 基因突变； 6. 最佳强度的估计 房颤抗凝； 7. 确定控制不良的决定因素 抗凝； 8. 识别使用的相关因素 房颤的抗凝治疗； 9.抗凝质量比较 由抗凝单位提供的服务与初级医生提供的服务相比。 这 研究人员表示，这项研究应该会带来重要的健康和 为美国老年人带来经济利益。