Comparative-Effectiveness of Procedures for Carotid Revascularization

颈动脉血运重建手术的比较效果

• 批准号: 10664391
• 负责人: Jesse A Columbo
• 金额: $ 14.68万
• 依托单位: DARTMOUTH-HITCHCOCK CLINIC
• 依托单位国家: 美国
• 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
• 来源: https://reporter.nih.gov/project-details/10664391
• 关键词: Accounting; Area; Arteries; Award; Blood Platelets; Blood Vessels; Caring; Carotid Arteries; Carotid Endarterectomy; Carotid Stenosis; Carotid stent; Cessation of life; Characteristics; Cholesterol; Clinical Trials; Comparative Effectiveness Research; Complement; Data; Data Collection; Data Set; Decision Making; Derivation procedure; Development; Disease; Education; Effectiveness; Eligibility Determination; Event; Excision; Femur; Foundations; Future; Goals; Grant; Implant; Individual; Ischemic Stroke; Knowledge; Link; Longterm Follow-up; Machine Learning; Medical; Medicare claim; Medicine; Mentors; Mentorship; Modeling; Morbidity - disease rate; Observational Study; Operative Surgical Procedures; Outcome; Patient Care; Patients; Pharmaceutical Preparations; Play; Procedures; Prospective Studies; Publishing; Recommendation; Registries; Research; Research Personnel; Risk; Risk Factors; Role; Safety; Stroke; Stroke prevention; Subgroup; Techniques; Technology; Testing; Training; United States; United States National Institutes of Health; Validation; Vascularization; Work; Writing; arm; career; clinical application; clinical practice; cohort; comorbidity; comparative effectiveness; comparative trial; effectiveness evaluation; femoral artery; follow-up; high risk; mortality; mortality risk; patient stratification; patient subsets; post stroke; project-based learning; random forest; randomized trial; randomized, clinical trials; responsible research conduct; risk stratification; skills; stroke risk; stroke therapy; treatment effect; treatment planning

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中风的主要危险因素，这是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通过抗血小板和 3种降低胆固醇的药物，并被考虑用于程序血运重建，以降低其风险 4中。颈动脉血运重建有三种不同的程序：手术颈动脉内膜切除术（CEA）， 5经皮经济颈动脉支架（TF-CAS），以及最近批准的程序 2015年6月6日，肉豆蔻质动脉血运重建（TCAR）。 CEA和TF-CA的效率和安全性已经 7严格研究了十几个随机临床试验。但是，TCAR还没有，并且证据 8支持其使用目前仅限于小型单臂前瞻性研究和有希望的匹配分析 9随访有限。此外，康托德卫生赞助的随机试验的主要国家研究所 10非对称颈动脉狭窄的血运重建，颈动脉血运重建和医疗管理 11审判（CREST-2）于2014年12月开始，仍在进行中，不包括TCAR，因此 12无法解决TCAR的有效性问题。尽管如此，TCAR还是迅速流行了，现在 截至2022年4月 14两倍。首先，没有TCAR的持续比较试验，确定如何使用此新程序 15在当代实践中，依靠观察研究。在此提案中，我们将定义中风的5年风险 16在TCAR与CEA与TF-CAS之后。我们将解决对TCAR先前发表的研究的重要局限性， 17包括缺乏长期结果，考虑竞争的死亡风险以及确定患者的竞争风险 18最有可能受益于这一新程序。这样，我们将通知患者和临床医生 19角色TCAR应该在他们的治疗计划中扮演。其次，TCAR代表了一个机会，可以推进我们 20知识对这个新程序，只需填补Columbo博士的关键概念知识差距 21培训作为比较效果研究人员。在血管护理中，过程并不少见 22在没有随机试验的患者中实施。这使得使用比较效率研究 23观察数据至关重要，以确保患者接受安全有效的护理。 TCAR是一个很好的 24这类研究为何重要的例子。该修订奖将使Columbo博士能够在 25 Mentalship团队的指导，以进一步发展他在比较效应研究中的发展 26观察数据，负责任进行研究，解释和临床适用性的培训 27调查结果和赠款写作。本提案中概述的教育对象将完成Columbo博士的 28现有技能，并为他提供全面的技能，用于比较效果工作。而这些技能 29将用于评估该提案中的TCAR，它们广泛适用于评估新程序 将来会引入30个，从而启动了Columbo博士作为独立调查员的职业。

项目成果

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: Circulation. Cardiovascular interventions
• 作者: Columbo,JesseA;Stone,DavidH;Martinez-Camblor,Pablo;Goodney,PhilipP;O'Malley,AJames
• 通讯作者: O'Malley,AJames