Carotid angioplasty and stenting in the elderly

老年人颈动脉血管成形术和支架置入术

• 批准号: 7587680
• 负责人: BRAHMAJEE K NALLAMOTHU
• 金额: $ 19万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-30 至 2010-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7587680
• 关键词: Age; American; Angioplasty; Area; Blood Vessels; Cardiovascular system; Caring; Carotid Endarterectomy; Carotid Stenosis; Cessation of life; Clinical Trials; Data; Disease regression; Elderly; Endarterectomy; Gender; Healthcare Market; Hospital Referrals; Hospitals; Individual; Invasive; Knowledge; Medicare; Modeling; Modification; Morbidity - disease rate; Outcome; Patients; Physician' s Role; Physicians; Policy Maker; Population; Procedures; Provider; Public Health; Race; Rate; Research; Risk; Role; Services; Specialist; Stroke; Stroke prevention; Surgeon; Surgical incisions; United States; United States Centers for Medicare and Medicaid Services; United States Food and Drug Administration; Variant; base; day; experience; improved; innovation; interest; medical specialties; mortality; radiologist

DESCRIPTION (provided by applicant): Each year approximately 100,000 elderly Americans undergo carotid endarterectomy (CEA) to reduce their risk of stroke and death. This procedure involves an open surgical incision and may be associated with substantial risks of morbidity and mortality. A promising and innovative alternative to CEA is carotid angioplasty and stenting (CAS), a minimally-invasive, endovascular procedure that may be of particular benefit in high-risk patients. Since its initial approval by the Food and Drug Administration (FDA) in 2004, the use of CAS has disseminated rapidly across the United States. Despite growing enthusiasm for this procedure, data on its use and outcomes in the "real-world" are limited. It is unknown, for example, whether CAS is being used mostly as a substitute for CEA in high- risk patients or if it is being performed in patients who might otherwise not have been treated at all. Moreover, the choice to use CAS may also be heavily influenced by which types of physician specialists are performing it. CAS is performed not just by vascular surgeons, but by interventional cardiologists and radiologists - physicians not traditionally involved with CEA or stroke care in general. As suggested by research in other cardiovascular procedures, physician specialty and experience could be important determinants of procedure use, as well as patient outcomes. An improved understanding of these issues would have important implications for clinicians, policy- makers, and payers. Indeed, the Centers for Medicare & Medicaid Services (CMS) recently considered substantial modifications to its current national coverage decision for CAS. Discussions by CMS centered not only on expanding the possible indications for this procedure, but restricting the types of physician specialists who could determine its appropriateness in any individual patient. In this context, we propose to study two-related specific aims. Specific Aim 1 will examine the dissemination of CAS in healthcare markets across the United States. Specific Aim 2 will assess real- world outcomes of CAS in the elderly. For this proposal, we will use national Medicare data (2004-2007) and are particularly interested in the role of physician specialty and experience in use and outcomes of CAS. We anticipate our findings will inform policy-makers, payers, providers, and patients struggling to determine the role of this innovative procedure. PUBLIC HEALTH RELEVANCE: Each year approximately 100,000 elderly Americans with severe carotid artery stenosis undergo carotid endarterectomy (CEA) to reduce their risk of stroke and death. A promising and innovative alternative to CEA is carotid angioplasty and stenting (CAS), but little is known about the (1) use and (2) outcomes of this minimally-invasive procedure in the real world. We anticipate that findings from this study will add new knowledge to both these areas and help inform policy-makers, payers, providers and patients struggling to determine the optimal role of CAS in preventing stroke and death.

描述（由申请人提供）：每年约有 100,000 名美国老年人接受颈动脉内膜切除术 (CEA)，以降低中风和死亡的风险。该手术涉及开放式手术切口，可能与发病率和死亡率的巨大风险相关。 CEA 的一种有前景的创新替代方案是颈动脉血管成形术和支架置入术 (CAS)，这是一种微创血管内手术，可能对高危患者特别有益。自 2004 年首次获得美国食品药品监督管理局 (FDA) 批准以来，CAS 的使用已在美国迅速普及。尽管人们对这一过程的热情日益高涨，但有关其在“现实世界”中的使用和结果的数据仍然有限。例如，尚不清楚 CAS 是否主要用作高危患者中 CEA 的替代品，或者是否在本来可能根本未接受治疗的患者中进行。此外，使用 CAS 的选择也可能很大程度上受到执行 CAS 的医师类型的影响。 CAS 不仅由血管外科医生执行，还由介入心脏病专家和放射科医生（传统上不参与 CEA 或一般中风护理的医生）执行。正如其他心血管手术的研究表明，医生的专业和经验可能是手术使用以及患者结果的重要决定因素。加深对这些问题的理解将对临床医生、政策制定者和付款人产生重要影响。事实上，医疗保险和医疗补助服务中心 (CMS) 最近考虑对其当前的 CAS 全国承保决定进行重大修改。 CMS 的讨论不仅集中于扩大该手术的可能适应症，还限制了可以确定该手术是否适合任何个体患者的专家类型。在此背景下，我们建议研究两个相关的具体目标。具体目标 1 将研究 CAS 在美国医疗保健市场的传播情况。具体目标 2 将评估老年人 CAS 的现实结果。对于本提案，我们将使用国家医疗保险数据（2004-2007 年），并且对医生专业的作用以及 CAS 使用和结果的经验特别感兴趣。我们预计我们的研究结果将为政策制定者、付款人、提供者和努力确定这一创新程序的作用的患者提供信息。 公共卫生相关性：每年约有 100,000 名患有严重颈动脉狭窄的美国老年人接受颈动脉内膜切除术 (CEA)，以降低中风和死亡的风险。 CEA 的一种有前途且创新的替代方案是颈动脉血管成形术和支架置入术 (CAS)，但人们对这种微创手术在现实世界中的 (1) 使用和 (2) 结果知之甚少。我们预计这项研究的结果将为这两个领域增加新知识，并帮助决策者、付款人、医疗服务提供者和患者了解 CAS 在预防中风和死亡方面的最佳作用。