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意大利金属裸支架在现代经皮冠状动脉介入时代的使用多中心登记研究(AMARCORD):一项多中心观察性研究。

Italian Multicenter Registry of Bare Metal Stent Use in Modern Percutaneous Coronary Intervention Era (AMARCORD): A multicenter observational study.

机构信息

Interventional Cardiology Unit, GVM Care & Research Maria Cecilia Hospital, Cotignola, Italy.

Cardio-Thoracic-Vascular Department, San Raffaele Scientific Institute, Milan, Italy.

出版信息

Catheter Cardiovasc Interv. 2021 Feb 15;97(3):411-420. doi: 10.1002/ccd.28798. Epub 2020 Mar 21.

Abstract

OBJECTIVES

We aimed to evaluate the use of bare metal stent (BMS) implantation in current percutaneous coronary intervention (PCI) era, focusing on indications for use and clinical outcomes.

BACKGROUND

Limited data on BMS usage in current clinical practice are available.

METHODS

All patients who underwent PCI with at least one BMS implantation in 18 Italian centers from January 1, 2013 to December 31, 2017, were included in our registry. Rates of BMS use and reasons for BMS implantations were reported for the overall study period and for each year. Primary outcomes were mortality, bleeding (Bleeding Academic Research Consortium-BARC and Thrombolysis in Myocardial Infarction-TIMI non-CABG definitions), and major adverse cardiac events (MACE) defined as the composite of all-cause and cardiac death, any myocardial infarction, target vessel revascularization, or any stent thrombosis.

RESULTS

Among 58,879 patients undergoing PCI in the study period, 2,117 (3.6%) patients (mean age 73 years, 69.7% males, 73.3% acute coronary syndrome) were treated with BMS implantation (2,353 treated lesions). The rate of BMS implantation progressively decreased from 10.1% (2013) to 0.3% (2017). Main reasons for BMS implantation were: ST-elevation myocardial infarction (STEMI) (23.1%), advanced age (24.4%), and physician's perception of high-bleeding risk (34.0%). At a mean follow-up of 2.2 ± 1.5 years, all-cause and cardiac mortality were 25.6 and 12.7%, respectively; MACE rate was 35.3%, any bleeding rate was 13.0% (BARC 3-5 bleeding 6.3%, TIMI non-CABG major bleeding 6.1%).

CONCLUSION

In a large, contemporary, real-world, multicenter registry, BMS use progressively reduced over the last 5 years. Main reasons for BMS implantation were STEMI, advanced age, and physician's perception of high-bleeding risk. High rates of mortality and MACE were observed in this real-world high-risk population.

摘要

目的

我们旨在评估在当前经皮冠状动脉介入治疗(PCI)时代使用金属裸支架(BMS)的情况,重点关注使用指征和临床结果。

背景

目前关于 BMS 在临床实践中的应用数据有限。

方法

我们的注册研究纳入了 2013 年 1 月 1 日至 2017 年 12 月 31 日期间在意大利 18 个中心接受至少一次 BMS 植入的所有接受 PCI 的患者。报告了整个研究期间和每年 BMS 使用的情况和 BMS 植入的原因。主要结局是死亡率、出血(BARC 和 TIMI 非 CABG 定义的出血学术研究联合会)和主要不良心脏事件(MACE),定义为全因和心脏死亡、任何心肌梗死、靶血管血运重建或任何支架血栓形成的复合事件。

结果

在研究期间接受 PCI 的 58879 例患者中,2117 例(3.6%)患者(平均年龄 73 岁,69.7%为男性,73.3%为急性冠状动脉综合征)接受了 BMS 植入(2353 个治疗病变)。BMS 植入的比例从 2013 年的 10.1%逐渐降至 2017 年的 0.3%。BMS 植入的主要原因是:ST 段抬高型心肌梗死(STEMI)(23.1%)、高龄(24.4%)和医生认为出血风险高(34.0%)。平均 2.2±1.5 年的随访期间,全因死亡率和心脏死亡率分别为 25.6%和 12.7%;MACE 发生率为 35.3%,任何出血发生率为 13.0%(BARC 3-5 级出血 6.3%,TIMI 非 CABG 大出血 6.1%)。

结论

在一项大型、当代、真实世界、多中心注册研究中,过去 5 年 BMS 的使用逐渐减少。BMS 植入的主要原因是 STEMI、高龄和医生认为出血风险高。在这个真实世界的高危人群中,死亡率和 MACE 发生率较高。

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