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

基本信息

  • 批准号:
    8503392
  • 负责人:
  • 金额:
    $ 77.06万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2013
  • 资助国家:
    美国
  • 起止时间:
    2013-06-01 至 2018-04-30
  • 项目状态:
    已结题

项目摘要

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)已证实颈动脉内膜切除术(CEA)在预防无症状和有症状颈动脉狭窄患者中风方面优于药物治疗。然而,虽然大多数接受颈动脉血运重建的患者接受无症状疾病的治疗,但血运重建对无症状疾病患者的益处相当有限。此外,临床试验大约在20年前就开始了,在此期间,由于新的药理学进展,如高效他汀类药物、改进的抗血小板治疗方案以及更好地控制高血压、高脂血症,这种血管疾病的药物治疗有了很大的改善。和糖尿病。与此同时,随着 CEA 手术并发症发生率的下降,颈动脉支架置入术 (CAS) 在治疗无症状颈动脉狭窄方面越来越受到青睐。虽然最近的试验主要集中于比较 CEA 和 CAS,但与药物治疗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手术是否优于积极的血管危险因素控制。三臂随机对照试验可以回答这个问题,但这样的研究将非常昂贵,并且在很长一段时间内无法提供答案,并且可能只招募通常在随机对照试验中研究的最健康患者的子集。自从第一个随机对照试验发表以来,证明了 CEA 相对于药物治疗的优越性,人们担心试验中观察到的适度益处可能无法在社区中重现。为了解决关于在无症状颈动脉狭窄患者中 CEA 是否仍然优于药物治疗以及 CAS 是否优于药物治疗(从未在随机对照试验中进行过评估)的争论,我们建议检查初始药物治疗的比较效果。在一项对 6000 名患者进行的回顾性队列研究中,使用退伍军人健康管理局和医疗保险的合并数据,将治疗与早期颈动脉干预进行了比较。我们将专门将每种血运重建策略与药物治疗进行比较,并检查一些关键变量(例如年龄、心房颤动的存在)对干预与药物治疗的相对有效性的影响。我们将使用先进的统计技术来克服药物治疗和干预队列中观察到和未观察到的差异。我们将比较 2005 年至 2008 年进入队列的 3175 名接受药物治疗的患者、1500 名接受 CEA 的患者和 1325 名接受 CAS 的患者的 30 天和 5 年结果。我们的总体假设是,药物治疗已改善到以下程度:只有某些亚组的患者可能从血运重建中受益,对于许多患者来说,药物治疗可能是首选的治疗策略。

项目成果

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会议论文数量(0)
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Salomeh Keyhani其他文献

Salomeh Keyhani的其他文献

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{{ truncateString('Salomeh Keyhani', 18)}}的其他基金

Marijuana Use in Older Adults: Health, Function and Fall-Related Injury
老年人吸食大麻:健康、功能和跌倒相关伤害
  • 批准号:
    10132223
  • 财政年份:
    2019
  • 资助金额:
    $ 77.06万
  • 项目类别:
Marijuana Use in Older Adults: Health, Function and Fall-Related Injury
老年人吸食大麻:健康、功能和跌倒相关伤害
  • 批准号:
    10576324
  • 财政年份:
    2019
  • 资助金额:
    $ 77.06万
  • 项目类别:
Risks of Cannabis Use Among Veterans on Long-term Opioid Therapy
长期接受阿片类药物治疗的退伍军人吸食大麻的风险
  • 批准号:
    10312709
  • 财政年份:
    2019
  • 资助金额:
    $ 77.06万
  • 项目类别:
Risks of Cannabis Use Among Veterans on Long-term Opioid Therapy
长期接受阿片类药物治疗的退伍军人吸食大麻的风险
  • 批准号:
    10817659
  • 财政年份:
    2019
  • 资助金额:
    $ 77.06万
  • 项目类别:
Marijuana Use in Older Adults: Health, Function and Fall-Related Injury
老年人吸食大麻:健康、功能和跌倒相关伤害
  • 批准号:
    10360509
  • 财政年份:
    2019
  • 资助金额:
    $ 77.06万
  • 项目类别:
Impact of marijuana on adherence, risk factor control and cardiovascular events
大麻对依从性、危险因素控制和心血管事件的影响
  • 批准号:
    9404476
  • 财政年份:
    2017
  • 资助金额:
    $ 77.06万
  • 项目类别:
An Evaluation of Novel Domains for Predicting 30-Day Readmission
对预测 30 天再入院的新领域的评估
  • 批准号:
    8576427
  • 财政年份:
    2013
  • 资助金额:
    $ 77.06万
  • 项目类别:
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
  • 财政年份:
    2013
  • 资助金额:
    $ 77.06万
  • 项目类别:

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