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：（根据调查员的摘要改编）房颤 （AF）影响60岁以上的4％的人，这也是最有效的风险 中风因素（相对风险5）；所有中风的15％，包括> 30％ 那些年龄> 80岁的人归因于AF。 七个随机试验（RCT）具有 显示的抗凝方法几乎可以安全地消除几乎所有的中风风险 AF。 但是，只有1/3的AF患者接受治疗 抗凝剂，其中只有19％的年龄> 80岁。 医师是 关注华法林在通常的实践中的安全，尤其是在 老年人，以及监测抗凝的负担。 关注 关于出血风险的一些观察性研究支持 临床实践，并通过一个RCT（SPAF II）。 结果，最近几个 指南建议将阿司匹林用于老年人，尽管证据 因为它在AF中的功效很弱。 当前的应用程序旨在提供丰富的信息来源 关于“现实世界”实践中AF的抗凝作用，以最佳翻译 在RCT中看到的疗效进入了通常的临床护理。 它也会 提供一种评估AF中中风风险的遗传标志的资源。 调查人员将组装两个大型队列：1。8000门诊儿 与AF在CA北部的Kaiser Permanente中；和2。2500名患者 由马萨诸塞州综合医院抗凝治疗部门管理。 这些队列的后续措施将解决两个重要的，链接的主题，因为 如下：1。在临床实践中指定中风和 抗凝剂的AF患者出血；和2。 确定优化控制抗凝的策略。 详细， 该研究将提供以下内容：1。精确且可推广 估计AF患者在华法林的主要出血率的估计 临床护理； 2。主要出血的临床风险因素，特别是 评估年龄较大； 3。精确估计血栓栓塞率 （TE）在不使用抗凝剂的AF患者中； 4。临床风险因素 与AF； 5。评估血栓形成风险的新标志 - 因子V Leiden基因突变； 6。估计的最佳强度 AF的抗凝； 7。鉴定控制不良的决定因素 抗凝； 8。识别使用的相关性 AF中的抗凝治疗；和9。抗凝质量的比较 由抗凝单元与主要医生提供的单位提供。 这 调查人员指出，这项研究应导致重要的健康和 老年人的经济利益。