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法国 PCI 注册研究:设计、方法学和主要发现。

The France PCI registry: Design, methodology and key findings.

机构信息

Cardiology Department, Les Hôpitaux de Chartres, 28630 Chartres, France.

Cardiology Department, University Hospital Gabriel-Montpied, 63000 Clermont-Ferrand, France.

出版信息

Arch Cardiovasc Dis. 2023 Nov;116(11):489-497. doi: 10.1016/j.acvd.2023.08.005. Epub 2023 Sep 22.

DOI:10.1016/j.acvd.2023.08.005
PMID:37783602
Abstract

BACKGROUND

Obstructive coronary artery disease is the main cause of death worldwide. By tracking events and gaining feedback on patient management, the most relevant information is provided to public health services to further improve prognosis.

AIMS

To create an inclusive and accurate registry of all percutaneous coronary intervention (PCI) procedures performed in France, to assess and improve the quality of care and create research incentives. Also, to describe the methodology of this French national registry of interventional cardiology, and present early key findings.

METHODS

The France PCI registry is a multicentre observational registry that includes consecutive patients undergoing coronary angiography and/or PCI. The registry was set up to provide online data analysis and structured reports of PCI activity, including process of care measures and assessment of risk-adjusted outcomes in all French PCI centres that are willing to participate. More than 150 baseline data items, describing demographic status, PCI indications and techniques, and in-hospital and 1-year outcomes, are captured into local reporting software by medical doctors and local research technicians, with subsequent encryption and internet transfer to central data servers. Annual activity reports and scoring tools available on the France PCI website enable users to benchmark and improve clinical practices. External validation and consistency assessments are performed, with feedback of data completeness to centres.

RESULTS

Between 01 January 2014 and 31 December 2022, participating centres increased from six to 47, and collected 364,770 invasive coronary angiograms and 176,030 PCIs, including 54,049 non-ST-segment elevation myocardial infarction cases and 31,631 ST-segment elevation myocardial infarction cases. Fifteen studies stemming from the France PCI registry have already been published.

CONCLUSIONS

This fully electronic, daily updated, high-quality, low-cost, national registry is sustainable, and is now expanding. Merging with medicoeconomic databases and nested randomized scientific studies are ongoing steps to expand its scientific potential.

摘要

背景

阻塞性冠状动脉疾病是全球范围内主要的死亡原因。通过跟踪事件并获得患者管理反馈,为公共卫生服务提供最相关的信息,以进一步改善预后。

目的

创建一个包容和准确的法国所有经皮冠状动脉介入治疗(PCI)手术的注册中心,评估和改善护理质量并创造研究激励机制。此外,还描述了该法国介入心脏病学国家注册中心的方法,并介绍了早期的关键发现。

方法

法国 PCI 注册中心是一个多中心观察性注册中心,包括接受冠状动脉造影和/或 PCI 的连续患者。该注册中心旨在提供在线数据分析和 PCI 活动的结构化报告,包括所有愿意参与的法国 PCI 中心的护理过程措施和风险调整结局评估。超过 150 个基线数据项,描述人口统计学状况、PCI 适应证和技术以及住院和 1 年结局,由医生和当地研究技术人员在本地报告软件中捕获,随后进行加密并通过互联网传输到中央数据服务器。法国 PCI 网站上提供的年度活动报告和评分工具使用户能够进行基准测试和改善临床实践。正在进行外部验证和一致性评估,并向中心反馈数据完整性。

结果

2014 年 1 月 1 日至 2022 年 12 月 31 日期间,参与中心从 6 个增加到 47 个,收集了 364770 例有创冠状动脉造影和 176030 例 PCI,包括 54049 例非 ST 段抬高型心肌梗死病例和 31631 例 ST 段抬高型心肌梗死病例。已有 15 项源自法国 PCI 注册中心的研究已发表。

结论

这个完全电子化、每日更新、高质量、低成本、全国性的注册中心是可持续的,并且正在不断扩大。与医疗经济数据库的合并以及嵌套随机科学研究正在进行中,以扩大其科学潜力。

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