EPIDEMIOLOGY OF ANTICOAGULATION IN ATRIAL FIBRILLATION

心房颤动抗凝治疗的流行病学

• 批准号: 2622515
• 负责人: DANIEL EDWIN SINGER
• 金额: $ 68.05万
• 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 2000-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2622515
• 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）房颤 (AF)它影响了4%的60岁以上的人，也是最大的风险 中风因素（相对风险为5）;所有中风的15%，包括> 30%， 这些年龄> 80，是由于AF。七个随机试验（RCT） 显示抗凝治疗可以安全地消除几乎所有的中风风险， af. 尽管如此，只有1/3的AF患者接受 抗凝剂，包括只有19%的年龄> 80。 医生是 关注华法林在常规实践中的安全性，特别是在 老年人，以及监测抗凝治疗的负担。 关切 关于出血风险的一些观察性研究支持， 临床实践和一项RCT（SPAF II）。 因此，最近几次 指南建议老年人使用阿司匹林，尽管有证据表明， 因为它对房颤的疗效很弱。 当前应用程序旨在提供丰富的信息源 关于房颤抗凝治疗在"真实的世界"实践中的最佳转化 将RCT中观察到的疗效纳入常规临床护理。 它还将 为评估AF卒中风险的遗传标记提供了资源。 研究人员将收集两个大的队列：1。 8000名门诊病人 在北方CA的Kaiser Permanente患有AF;以及2. 2500名患者 由大众管理。 综合医院抗凝治疗科。 对这些群体的后续行动将涉及两个重要的、相互关联的主题， 如下：1. 在临床实践中规定中风率， AF患者在使用和停用抗凝剂时的出血情况; 2. 确定优化抗凝控制的策略。 详细地说， 本研究将提供以下几点：1。 精确和可推广的 使用华法林的房颤患者的大出血率估计值， 临床护理; 2. 大出血的临床风险因素，特别是 评估年龄; 3. 血栓栓塞发生率的精确估计 (TE)在未使用抗凝剂的AF患者中; 4. 临床危险因素 AF; 5。 评估血栓形成风险的新标志物-- 因子V Leiden基因突变; 6. 最优强度的估计 房颤抗凝治疗; 7. 识别控制不良的决定因素 抗凝; 8. 使用的相关因素的识别 AF中的抗凝;和9. 抗凝质量比较 由抗凝单位提供，而不是由主治医生提供。 的 研究人员指出，这项研究应该导致重要的健康和 为美国老年人带来经济利益。