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

基本信息

批准号：
8794456
负责人：
Elaine Hylek
金额：
$ 51.25万
依托单位：
BOSTON MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-02-16 至 2017-01-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8794456
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 Kidney Diseases Knowledge Lead Living Costs Low-Molecular-Weight Heparin Lung Methods 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 strategy Prevention trial 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 predictive modeling routine care routine practice sex simulation

项目摘要

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）：在美国，静脉血栓栓塞 (VTE) 导致 100,000-180,000 人死亡，超过 250,000 人住院，每次事件每年造成 13,000 至 20,000 美元的损失。 VTE 是继心肌梗塞和中风之后心血管死亡的第三大原因。 VTE 的长期后遗症包括血栓后综合征和肺动脉高压，它们均与健康相关生活质量 (HRQOL) 低、生存率低和费用高有关。如果不进行预防，髋关节或膝关节置换术后 VTE 的发生率为 40-60%。考虑到与 VTE 相关的死亡率和发病率，人们普遍认为应进行 VTE 预防，但最佳预防措施尚不确定，且争议不断。专业共识指南的不同导致临床实践的巨大差异。据报道，使用强效抗凝剂后的全因死亡率更高，进一步加剧了不确定性，而且 VTE 预防试验的汇总分析报告称，发生严重出血事件的患者的死亡风险增加了 7 倍。医学研究所已将关节置换后的 VTE 预防指定为比较有效性研究的优先领域，以更好地阐明不同抗血栓策略在现实世界实践中护理的不同患者群体中的益处和危害。医学上复杂的患者、年龄最大的患者以及中度至重度肥胖的患者在试验中的代表性严重不足。此外，很少有试验纳入有关干预措施相关的长期 HRQOL、生存率和成本的信息，而这些对于患者、提供者和政策制定者来说是最重要的结果。为了解决这些问题，我们将前瞻性地收集来自 65 家社区医院超过 21,000 名接受选择性关节置换术的患者的队列，以比较不同 VTE 预防方案的有效性。我们将使用各种方法（风险模型、倾向评分、疾病模拟模型）来指导未选择的社区患者群体中 VTE 预防的选择，这些患者比之前研究的人群年龄更大、病情更重。利用健康指标研究所的独特资产，我们将追求以下目标：1) 按年龄和性别确定髋关节或膝关节置换术后 90 天内 VTE、大出血和死亡率的发生率，2) 制定风险-关节置换术后 VTE、出血和死亡率的预测模型，3) 比较高强度与低强度 VTE 预防策略的有效性和危害，以及 4) 确定使用疾病模拟来评估 VTE 预防药物的健康质量、生存率和成本。减少 VTE 是美国一个紧迫的健康问题。研究人员精通大规模研究的进行，并贡献互补的专业知识。我们的提案将弥补我们在常规实践中对不同患者不同抗血栓策略的安全性和有效性的理解方面的关键知识差距。考虑到该患者群体预计需要进行关节置换，其对公共卫生的意义是巨大的。

项目成果

期刊论文数量（10）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Antiplatelet therapy in prevention of cardio- and venous thromboembolic events.

抗血小板治疗预防心脏和静脉血栓栓塞事件。

DOI：
发表时间：
2014-04
期刊：
影响因子：
4
作者：
Steinhubl, Steven R;Eikelboom, John W;Hylek, Elaine M;Dauerman, Harold L;Smyth, Susan S;Becker, Richard C
通讯作者：
Becker, Richard C

Thrombosis: a major contributor to global disease burden.

血栓形成：全球疾病负担的一个主要因素。

DOI：
发表时间：
2014-11
期刊：
影响因子：
0
作者：
Raskob, G E;Angchaisuksiri, P;Blanco, A N;Buller, H;Gallus, A;Hunt, B J;Hylek, E M;Kakkar, A;Konstantinides, S V;McCumber, M;Ozaki, Y;Wendelboe, A;Weitz, J I;ISTH Steering Committee for World Thrombosis Day
通讯作者：
ISTH Steering Committee for World Thrombosis Day

Risk of thromboembolism, recurrent hemorrhage, and death after warfarin therapy interruption for gastrointestinal tract bleeding.

因胃肠道出血而中断华法林治疗后存在血栓栓塞、复发性出血和死亡的风险。

DOI：
发表时间：
2012-10-22
期刊：
影响因子：
0
作者：
Witt, Daniel M;Delate, Thomas;Garcia, David A;Clark, Nathan P;Hylek, Elaine M;Ageno, Walter;Dentali, Francesco;Crowther, Mark A
通讯作者：
Crowther, Mark A

Anticoagulation reversal in vitamin K antagonist-associated intracerebral hemorrhage: a systematic review.

维生素 K 拮抗剂相关脑出血的抗凝逆转：系统评价。