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当代美国无保护左主干冠状动脉经皮冠状动脉介入治疗的应用和趋势:国家心血管数据注册研究实践倡议分析。

Contemporary Use and Trends in Unprotected Left Main Coronary Artery Percutaneous Coronary Intervention in the United States: An Analysis of the National Cardiovascular Data Registry Research to Practice Initiative.

机构信息

Rocky Mountain Veterans Affairs Medical Center, Aurora, Colorado.

University of Colorado School of Medicine, Aurora.

出版信息

JAMA Cardiol. 2019 Feb 1;4(2):100-109. doi: 10.1001/jamacardio.2018.4376.

Abstract

IMPORTANCE

Recent data support percutaneous revascularization as an alternative to coronary artery bypass grafting in unprotected left main (ULM) coronary lesions. However, the relevance of these trials to current practice is unclear, as patterns and outcomes of ULM percutaneous coronary intervention (PCI) in contemporary US clinical practice are not well studied.

OBJECTIVE

To define the current practice of ULM PCI and its outcomes and compare these with findings reported in clinical trials.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional multicenter analysis included data collected from 1662 institutions participating in the National Cardiovascular Data Registry (NCDR) CathPCI Registry between April 2009 and July 2016. Data were collected from 33 128 patients undergoing ULM PCI and 3 309 034 patients undergoing all other PCI. Data were analyzed from June 2017 to May 2018.

MAIN OUTCOMES AND MEASURES

Patient and procedural characteristics and their temporal trends were compared between ULM PCI and all other PCI. In-hospital major adverse clinical events (ie, death, myocardial infarction, stroke, and emergent coronary artery bypass grafting) were compared using hierarchical logistic regression. Characteristics and outcomes were also compared against clinical trial cohorts.

RESULTS

Of the 3 342 162 included patients, 2 223 570 (66.5%) were male, and the mean (SD) age was 64.2 (12.1) years. Unprotected left main PCI represented 1.0% (33 128 of 3 342 162) of all procedures, modestly increasing from 0.7% to 1.3% over time. The mean (SD) annualized ULM PCI volume was 0.5 (1.5) procedures for operators and 3.2 (6.1) procedures for facilities, with only 1808 of 10 971 operators (16.5%) and 892 of 1662 facilities (53.7%) performing an average of 1 or more ULM PCI annually. After adjustment, major adverse clinical events occurred more frequently with ULM PCI compared with all other PCI (odds ratio, 1.46; 95% CI, 1.39-1.53). Compared with clinical trial populations, patients in the CathPCI Registry were older with more comorbid conditions, and adverse events were more frequent.

CONCLUSIONS AND RELEVANCE

Use of ULM PCI has increased over time, but overall use remains low. These findings suggest that ULM PCI occurs infrequently in the United States and in an older and more comorbid population than that seen in clinical trials.

摘要

重要性

最近的数据支持经皮血运重建作为未保护左主干(ULM)冠状动脉病变的冠状动脉旁路移植术的替代方法。然而,这些试验与当前实践的相关性尚不清楚,因为当前美国临床实践中 ULM 经皮冠状动脉介入治疗(PCI)的模式和结果尚未得到很好的研究。

目的

定义 ULM PCI 的当前实践及其结果,并将其与临床试验中的发现进行比较。

设计、设置和参与者:本横断面多中心分析纳入了 2009 年 4 月至 2016 年 7 月期间参加国家心血管数据注册(NCDR)CathPCI 注册中心的 1662 个机构收集的数据。数据来自 33128 例行 ULM PCI 和 3309034 例行所有其他 PCI 的患者。数据分析于 2017 年 6 月至 2018 年 5 月进行。

主要终点和测量

比较 ULM PCI 和所有其他 PCI 患者和手术特征及其时间趋势。使用分层逻辑回归比较住院期间主要不良临床事件(即死亡、心肌梗死、卒中和紧急冠状动脉旁路移植术)。还与临床试验队列比较了特征和结果。

结果

在 3342162 例纳入患者中,2223570 例(66.5%)为男性,平均(SD)年龄为 64.2(12.1)岁。未保护的左主干 PCI 占所有手术的 1.0%(33128 例/3342162 例),随时间推移略有增加,从 0.7%增加到 1.3%。经操作人员和医疗机构每年平均进行 0.5(1.5)次和 3.2(6.1)次操作,只有 10971 名操作人员中的 1808 名(16.5%)和 1662 个医疗机构中的 892 名(53.7%)每年进行 1 次或更多次 ULM PCI。调整后,与所有其他 PCI 相比,ULM PCI 发生主要不良临床事件的频率更高(优势比,1.46;95%CI,1.39-1.53)。与临床试验人群相比,CathPCI 登记处的患者年龄更大,合并症更多,不良事件更频繁。

结论和相关性

随着时间的推移,ULM PCI 的使用有所增加,但总体使用率仍然较低。这些发现表明,在美国,ULM PCI 的应用频率较低,而且患者年龄较大,合并症较多,与临床试验中的情况不同。

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