Effectiveness and Safety of Antithrombotic Strategies after Joint Replacement

关节置换术后抗血栓策略的有效性和安全性

• 批准号: 8425099
• 负责人: Elaine Hylek
• 金额: $ 57.41万
• 依托单位: BOSTON MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-02-16 至 2016-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8425099
• 关键词: Accounting; Acute suppurative arthritis due to bacteria; Address; Age; Agreement; American; Anticoagulants; Area; Arthroplasty; Aspirin; Cardiovascular system; Cessation of life; Chest; Clinical Trials; Communities; Community Hospitals; Complex; Consensus; Data; Data Sources; Databases; Diabetes Mellitus; Disease; Effectiveness; Elderly; Embolism; Enrollment; Ensure; Epoetin Alfa; Evaluation; Event; Guidelines; Health; Heart Diseases; Hemorrhage; Hip region structure; Hospitalization; Hyperglycemia; Incidence; Infection; Institute of Medicine (U.S.); Institutes; International Normalized Ratio; Intervention; Joint by Site; Joints; Kidney Diseases; Knowledge; Lead; Living Costs; Low-Molecular-Weight Heparin; Lung; Methods; Metric; Modeling; Morbid Obesity; Morbidity - disease rate; Myocardial Infarction; Obesity; Operative Surgical Procedures; Orthopedic Surgery procedures; Orthopedics; Outcome; Participant; Patient Care; Patients; Pharmaceutical Preparations; Physicians; Policy Maker; Population; Population Study; Postphlebitic Syndrome; Prevalence; Prevention; Prevention strategy; Prophylactic treatment; Provider; Public Health; Publishing; Pulmonary Hypertension; Regimen; Replacement Arthroplasty; Reporting; Research Personnel; Risk; Rural Community; Rural Hospitals; Safety; Stroke; Surgeon; Thromboembolism; Total Hip Replacement; Uncertainty; United States; Variant; Venous; Warfarin; age group; base; clinical practice; cohort; college; comparative effectiveness; compare effectiveness; cost; cost effective; cost effectiveness; effectiveness research; fondaparinux; health related quality of life; high risk; joint stiffness; knee replacement arthroplasty; medical specialties; models and simulation; mortality; novel; patient population; public health relevance; routine care; routine practice; sex; simulation

DESCRIPTION (provided by applicant): Venous thromboembolism (VTE) accounts for 100,000-180,000 deaths, greater than 250,000 hospitalizations, and between $13,000 and $20,000 annually per event in the United States. VTE is the third leading cause of cardiovascular death after myocardial infarction and stroke. The long-term sequelae of VTE include post thrombotic syndrome and pulmonary hypertension which are each associated with low health-related quality of life (HRQOL), reduced survival, and high costs. Without prophylaxis, the prevalence of VTE following hip or knee arthroplasty is 40-60%. Given the mortality and morbidity associated with VTE, there is universal agreement that VTE prophylaxis should be given, but optimal prophylaxis is uncertain and increasingly controversial. Specialty consensus guidelines differ leading to wide variation in clinical practice. Further heightening the uncertainty, higher all-cause mortality has been reported with use of potent anticoagulants and a pooled analysis of VTE prevention trials reported a 7-fold higher risk of death among patients who sustained a major bleeding event. The Institute of Medicine has designated VTE prophylaxis following joint replacement as a priority area for comparative effectiveness research to better elucidate the benefits and harms of different antithrombotic strategies among the diverse groups of patients cared for in real-world practice. Medically complex patients, patients in the oldest age groups, and those with moderate to severe obesity are vastly under-represented in trials. In addition, few trials incorporate information about an intervention's associated long term HRQOL, survival, and cost, which are the outcomes most important to patients, providers, and policy makers. To address these concerns, we will prospectively assemble a cohort of >21,000 patients undergoing elective joint replacement from 65 community hospitals to compare the effectiveness of different regimens of VTE prophylaxis. We will use various methods (risk modeling, propensity scores, disease simulation modeling) to inform the choice of VTE prophylaxis in a population of unselected, community-based patients who are older and sicker than previously studied populations. Utilizing the unique assets of the Institute for Health Metrics, we will pursue the following aims: 1) to determine incidence of VTE, major hemorrhage, and mortality within 90 days of hip or knee arthroplasty by age and sex, 2) to develop risk-prediction models for VTE, hemorrhage, and mortality following arthroplasty, 3) to compare the effectiveness and harms associated with high intensity versus low intensity VTE prevention strategies, and 4) to determine the health quality, survival, and costs for VTE prophylaxis agents using disease simulation. Reduction of VTE is a pressing U.S. health concern. The study investigators are well-versed in the conduct of large scale studies and contribute complementary expertise. Our proposal will inform critical knowledge gaps in our understanding of the safety and efficacy of different antithrombotic strategies across the spectrum of patients in routine practice. The public health significance is enormous given the projected need for joint replacement in this patient population.

描述（由申请人提供）：静脉血栓栓塞（VTE）占100,000-180,000人的死亡，超过250,000次住院治疗，每年在美国每年每年的每年13,000至20,000美元之间。 VTE是心肌梗死和中风后心血管死亡的第三主要原因。 VTE的长期后遗症包括血栓形成后综合征和肺动脉高压，它们都与低健康相关的生活质量（HRQOL），生存率降低和高成本有关。没有预防，髋或膝关节置换术后VTE的患病率为40-60％。鉴于与VTE相关的死亡率和发病率，普遍同意应预防VTE，但最佳预防是不确定的，并且越来越有争议。专业共识指南有所不同，导致临床实践的广泛差异。据报道，通过使用有效的抗凝剂的使用，已经据报道了不确定性，全因死亡率较高，并且对VTE预防试验进行的合并分析报告说，发生重大出血事件的患者的死亡风险高7倍。联合替代后，医学研究所将VTE预防指定为比较有效性研究的优先领域，以更好地阐明在现实世界实践中所关心的各种患者中不同抗强化策略的益处和危害。在试验中，医学复杂的患者，年龄最大的患者以及中度至重度肥胖症患者的代表性差不多。此外，很少有试验包含有关干预措施相关的长期HRQOL，生存和成本的信息，这对患者，提供者和政策制定者最重要。为了解决这些问题，我们将前瞻性地组装> 21,000名接受选修联合替代的患者的队列，以比较VTE预防的不同方案的有效性。我们将使用各种方法（风险建模，倾向得分，疾病模拟建模）来告知与先前研究的人群年龄更大，更病的未选择的，基于社区的患者的VTE预防选择。利用健康指标研究所的独特资产，我们将追求以下目的：1）确定VTE的发生率，重大出血和死亡率在髋关节或膝关节成形术的90天内按年龄和性别按年龄和性别开发，2）以VTE，出血性，3）的浓度为较高的浓度，并危害较高的浓度，并危害较高的浓度，并危害较高的浓度，3）策略和4）使用疾病模拟确定VTE预防药物的健康质量，生存和成本。 VTE的减少是美国卫生问题。研究研究人员对大规模研究的进行良好，并贡献了互补的专业知识。我们的建议将在我们对常规实践中各个患者范围内不同抗血栓形成策略的安全性和有效性的理解时为关键的知识差距提供信息。鉴于该患者人群的联合替代需求预计，公共卫生的重要性是巨大的。