Comparative Effectiveness of Carotid Artery Revascularization vs Medical Therapy

颈动脉血运重建与药物治疗的疗效比较

• 批准号: 8666037
• 负责人: Salomeh Keyhani
• 金额: $ 73.33万
• 依托单位: NORTHERN CALIFORNIA INSTITUTE/RES/EDU
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-06-01 至 2015-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8666037
• 关键词: Address; Age; Atrial Fibrillation; Blood Pressure; Carotid Arteries; Carotid Endarterectomy; Carotid Stenosis; Cessation of life; Clinical; Clinical Trials; Cohort Studies; Communities; Data; Development; Diabetes Mellitus; Diagnosis; Disease; Early Intervention; Effectiveness of Interventions; Enrollment; Hyperlipidemia; Intention; Intervention; Medical; Medicare; Myocardial Infarction; Operative Surgical Procedures; Outcome; Patients; Perioperative; Procedures; Publishing; Randomized Controlled Trials; Regimen; Reporting; Risk; Stroke; Stroke prevention; Subgroup; Surgical complication; Techniques; Therapeutic Intervention; Time; Transient Ischemic Attack; Vascular Diseases; Veterans; arm; base; cohort; comparative effectiveness; compare effectiveness; design; health administration; human old age (65+); hypertension control; improved; primary outcome; public health relevance; risk benefit ratio; treatment strategy; vascular risk factor

DESCRIPTION (provided by applicant): Randomized controlled trials (RCTs) have established that carotid endarterectomy (CEA) is superior to medical therapy in preventing stroke in both asymptomatic and symptomatic patients with carotid stenosis. However, while the majority of patients who undergo carotid revascularization receive treatment for asymptomatic disease, the benefit of revascularization for patients with asymptomatic disease is quite modest. In addition, the clinical trials were initiated about 20 years ago, and in the intervening period, medical therapy has greatly improved for this vascular disease due to new pharmacological advances such as high potency statins, improved antiplatelet regimens, and better control of hypertension, hyperlipidemia and diabetes. In parallel, as the surgical complication rate for CEA has decreased, the use of carotid artery stenting (CAS) has been gaining favor in the treatment of asymptomatic carotid stenosis. While recent trials have focused exclusively on comparing CEA to CAS, the declining stroke rate associated with medically managed carotid stenosis has led many to question whether either revascularization procedure is superior to aggressive vascular risk factor control. A three-arm RCT could answer this question, but such a study would be very expensive, not provide answers for a long time, and might only enroll the subset of healthiest patients typically studied in an RCT. Since the first RCT was published that demonstrated the superiority of CEA compared to medical therapy there has been a concern that the modest benefit observed in the trials may not be reproducible in the community. To address the ongoing debate of whether among patients with asymptomatic carotid stenosis, CEA is still superior to medical therapy and whether CAS is superior to medical therapy (which has never been evaluated in an RCT), we propose to examine the comparative effectiveness of initial medical therapy compared to early carotid intervention in a retrospective cohort study of 6000 patients using merged Veteran's Health Administration and Medicare data. We will specifically compare each revascularization strategy to medical therapy and also examine the impact of a number of key variables (e.g. age, presence of atrial fibrillation) on the comparative effectiveness of intervention compared to medical therapy. We will use advanced statistical techniques to overcome observed and unobserved differences in the medical therapy and intervention cohorts. We will compare the 30-day and 5 year outcomes of 3175 patients managed medically, 1500 patients who received CEA, and 1325 patients who received CAS entering the cohort from 2005 to 2008. Our overarching hypothesis is that medical therapy has improved to a degree that only certain subgroups of patients may benefit from revascularization and that for many patients medical therapy may be the preferred treatment strategy.

描述（由申请人提供）：随机对照试验（RCT）已经确定颈动脉内膜切除术（CEA）优于医疗疗法，可以预防无症状和有症状的颈动脉狭窄患者中风。然而，尽管大多数接受颈动脉血运动物血运重建的患者接受了无症状疾病的治疗，但血运重建的益处是无症状疾病患者的益处。此外，临床试验大约在20年前开始，在此期间，由于新的药理学进步，例如高效力汀类药物，改善抗血小板治疗方案，以及更好地控制高血压，高脂血症和糖尿病，因此，这种血管疾病的药物疗法大大改善。同时，随着CEA的手术并发症率降低，颈动脉支架（CAS）的使用在治疗无症状颈动脉狭窄方面已受到青睐。尽管最近的试验仅集中于将CEA与CAS进行比较，但与医学管理的颈动脉狭窄相关的中风率下降，导致许多人质疑这两种血运重建程序是否优于侵略性血管风险因素控制。三臂RCT可以回答这个问题，但是这样的研究将非常昂贵，很长一段时间都不能提供答案，并且可能只会注册通常在RCT中研究的最健康的患者。由于出版了第一个RCT，证明了与药物疗法相比，CEA的优越性，因此人们一直担心试验中观察到的适度益处在社区中可能无法再现。为了解决有关无症状颈动脉狭窄患者的持续争论，CEA仍然优于医疗疗法，以及CAS是否优于医疗治疗（从未在RCT中进行评估过），我们建议研究初始医疗疗法的比较有效性，与6000名使用合格的Veteran Advicional和Medical Advicisation的Retopective cothort研究相比，相比我们将专门将每种血运重建策略与医疗疗法进行比较，并研究许多关键变量（例如，年龄，存在房颤的存在）对与药物治疗相比的干预效果的影响。我们将使用先进的统计技术来克服医疗疗法和干预群体中观察到的和未观察到的差异。我们将比较3175例接受治疗的3175例患者的30天和5年成果，接受CEA的1500名患者以及1325例接受CAS的患者从2005年到2008年进入同队。我们的总体假设是，医疗治疗的一定程度是，只有患者的某些子组可能会受益于许多患者的药物治疗，并且对许多患者可能会受益于许多患者的治疗方法。