Comparative-Effectiveness of Procedures for Carotid Revascularization

颈动脉血运重建手术的比较效果

基本信息

  • 批准号:
    10664391
  • 负责人:
  • 金额:
    $ 14.68万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2023
  • 资助国家:
    美国
  • 起止时间:
    2023-06-01 至 2028-05-31
  • 项目状态:
    未结题

项目摘要

PROJECT SUMMARY 1 Carotid artery stenosis is a major risk factor for ischemic stroke, a leading cause of morbidity and mortality in the 2 United States. Patients with carotid stenosis are typically managed with a combination of antiplatelet and 3 cholesterol-lowering medications and are considered for procedural revascularization to decrease their risk of 4 stroke. There are three different procedures for carotid revascularization: surgical carotid endarterectomy (CEA), 5 percutaneous transfemoral carotid artery stenting (TF-CAS), and a procedure that was recently approved in 6 2015, transcarotid artery revascularization (TCAR). The efficacy and safety of CEA and TF-CAS have been 7 rigorously studied in more than a dozen randomized clinical trials. However, TCAR has not, and evidence 8 supporting its use is currently limited to small single-arm prospective studies and propensity-matched analyses 9 with limited follow up. Furthermore, the major National Institutes of Health-sponsored randomized trial of carotid 10 revascularization, the Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis 11 Trial (CREST-2), which began in December 2014 and is still in progress, does not include TCAR and therefore 12 cannot resolve the question of TCARs effectiveness. Despite this, TCAR has risen to rapid popularity and is now 13 in use at 570 centers in the United States with 30,951 implants as of April 2022. The objective of this project is 14 two-fold. First, with no ongoing comparative trial of TCAR, determining how this new procedure should be used 15 in contemporary practice relies on observational research. In this proposal, we will define the 5-year risk of stroke 16 after TCAR versus CEA versus TF-CAS. We will resolve important limitations of prior published studies of TCAR, 17 including lack of long-term results, accounting for the competing risk of death, and in establishing which patients 18 are most likely to benefit from this new procedure. In doing so, we will inform both patients and clinicians what 19 role TCAR should play in their treatment plans. Second, TCAR represents an opportunity to both advance our 20 knowledge of this new procedure, and simultaneously fill key conceptual knowledge gaps in Dr. Columbo’s 21 training as a comparative-effectiveness researcher. In vascular care, it is not uncommon for procedures to be 22 implemented in patients without a randomized trial. This makes comparative-effectiveness research using 23 observational data vital to ensure that patients are receiving safe and effective care. TCAR is an excellent 24 example of why this type of research is important. This mentored award will allow Dr. Columbo to work under 25 the guidance of the mentorship team to further his development in comparative-effectiveness research using 26 observational data, training in the responsible conduct of research, interpretation and clinical applicability of the 27 findings, and grant writing. The educational objectives outlined in this proposal will complement Dr. Columbo’s 28 existing skills and provide him with a well-rounded skillset for comparative-effectiveness work. While these skills 29 will be used to evaluate TCAR in this proposal, they are broadly applicable to evaluating new procedures that 30 are introduced in the future, launching Dr. Columbo’s career as an independent investigator.
项目摘要 1颈动脉狭窄是缺血性卒中的主要危险因素,缺血性卒中是老年人发病率和死亡率的主要原因。 2美国。颈动脉狭窄的患者通常用抗血小板药物和 3种降胆固醇药物,并考虑进行手术血运重建,以降低其风险 四杆。颈动脉血管重建术有三种不同的方法:外科颈动脉内膜切除术(CEA), 5例经皮经股动脉颈动脉支架植入术(TF-CAS),以及最近在 2015年6月,经颈动脉血运重建术(TCAR)。CEA和TF-CAS的有效性和安全性已被证实。 7在十几个随机临床试验中进行了严格的研究。然而,TCAR没有,证据 目前支持其使用的文献仅限于小型单臂前瞻性研究和倾向匹配分析 9、有限的后续行动此外,主要的国立卫生研究院赞助的颈动脉随机试验 10无症状颈动脉狭窄的血管重建、颈动脉血管重建和医疗管理 11试验(CREST-2)于2014年12月开始,目前仍在进行中,不包括TCAR,因此 12不能解决TCAR的有效性问题。尽管如此,TCAR已经迅速普及,现在 截至2022年4月,13在美国570个中心使用,植入30,951个植入物。本项目的目标是 14两重首先,由于没有正在进行的TCAR比较试验,确定如何使用这种新程序 15在当代实践中依赖于观察研究。在本提案中,我们将定义中风的5年风险 TCAR对比CEA对比TF-CAS后16例。我们将解决先前发表的TCAR研究的重要局限性, 17包括缺乏长期结果,考虑到死亡的竞争风险,以及确定哪些患者 18人最有可能从这一新程序中受益。在此过程中,我们将告知患者和临床医生 TCAR在其治疗计划中应发挥的19个作用。第二,TCAR代表了一个机会,既可以推进我们的 20这种新的程序的知识,同时填补关键概念知识的差距博士。 第21章作为一个研究者在血管护理中, 22例在未进行随机试验的患者中实施。这使得比较有效性研究使用 23个观察性数据对于确保患者获得安全有效的护理至关重要。TCAR是一个优秀的 24个例子说明为什么这种类型的研究是重要的。这个指导奖将允许哥伦布博士在 25导师团队的指导,以促进他在比较效益研究方面的发展, 26个观察数据,负责进行研究的培训,解释和临床适用性 27篇作文,作文本提案中概述的教育目标将补充哥伦布博士的 28个现有的技能,并为他提供了一个全面的技能比较有效的工作。虽然这些技能 29将用于评价本提案中的TCAR,它们广泛适用于评价新程序, 未来将推出30个,启动哥伦布博士作为独立调查员的职业生涯。

项目成果

期刊论文数量(4)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
Adoption and Diffusion of Transcarotid Artery Revascularization in Contemporary Practice.
经颈动脉血运重建术在当代实践中的采用和扩散。
  • DOI:
    10.1161/circinterventions.122.012805
  • 发表时间:
    2023
  • 期刊:
  • 影响因子:
    0
  • 作者:
    Columbo,JesseA;Stone,DavidH;Martinez-Camblor,Pablo;Goodney,PhilipP;O'Malley,AJames
  • 通讯作者:
    O'Malley,AJames
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Jesse A Columbo其他文献

Derivation and Validation of ICD-10 Codes for Identifying Incident Stroke.
用于识别中风事件的 ICD-10 代码的推导和验证。
  • DOI:
  • 发表时间:
    2024
  • 期刊:
  • 影响因子:
    29
  • 作者:
    Jesse A Columbo;N. Daya;Lisandro D. Colantonio;Zhixin Wang;Kathryn Foti;Hyacinth I. Hyacinth;Michelle C. Johansen;Rebecca F. Gottesman;Phillip P Goodney;Virginia J Howard;Paul Muntner;Andrea L C Schneider;Elizabeth Selvin;Caitlin W Hicks
  • 通讯作者:
    Caitlin W Hicks

Jesse A Columbo的其他文献

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