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临床试验/NCT03788148
NCT03788148已完成不适用

Bare-metal Stents(BMS) Versus Drug-eluting Stents(DES) in Patients Who Underwent Periprocedural Blood Transfusion : A Nationwide Longitudinal Cohort Study

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 28,322 人开始时间: 2018年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
28,322
试验地点
1
主要终点
Incidence density of MACE (Major adverse clinical events)

研究概览

简要总结

Retrospective cohort study of Korean National Healthcare Insurance Database. To investigate clinical outcomes of bare metal stents versus drug eluting stents in patients who underwent periprocedural red blood cell transfusion.

详细描述

A Korean nationwide, multi-center, retrospective observational cohort study.

The receipt of red blood cell transfusion is at high risk of cardiac events or death. But little is know regarding the comparative outcomes of BMS and DES implantation in patients who underwent periprocedural red blood cell transfusion.

Longitudinal data is collected from administrative claims in the national health insurance services of Korea. All Korean data(N=500,591) undergoing PCI from 2006 to 2015 is extracted. BMS or DES Patients(N=28,322) who received periprocedural red blood cell transfusion is investigate. Clinical outcomes until December 31, 2017 is investigate.

Primary endpoint is a time to the first major adverse clinical event(MACE) defined as a composite of all-cause death, revascularization, critically ill cardiovascular status, or stroke.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with percutaneous coronary intervention from 2006 to 2015
  • Patients with the implantation of BMS or DES
  • Patients with the receipt of periprocedural red blood cell transfusion

排除标准

  • Patients without any of stent implantation

结局指标

主要结局

Incidence density of MACE (Major adverse clinical events)

时间窗: 1 year

The first major adverse clinical event(MACE) defined as a composite of all-cause death, revascularization, critically ill cardiovascular status, and stroke.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jin-Ho Choi

MD, PhD, Professor, Principal Investigator

Samsung Medical Center

研究点 (1)

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