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临床试验/NCT03870815
NCT03870815招募中不适用

Registry for Long-term Clinical Outcomes and Prognostic Factors in Patient With Coronary Artery Disease Undergoing Coronary Artery Bypass Graft Surgery or Percutaneous Coronary Intervention With Second Generation Drug-Eluting Stent

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2019年2月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10,000
试验地点
1
主要终点
Cardiac Death

研究概览

简要总结

  1. To evaluate the long-term clinical outcomes and prognostic factors in patients with coronary artery disease undergoing coronary artery bypass graft surgery.
  2. To evaluate the long-term clinical outcomes and prognostic factors in patients with coronary artery disease undergoing percutaneous coronary intervention with drug-eluting stent.

详细描述

Coronary artery disease (CAD) still remains one of the world's leading causes of death, despite markedly improvement of devices and technologies on past several decades. The treatment strategy for CAD included medical treatment, percutaneous coronary intervention (PCI), and coronary-artery bypass grafting (CABG). CABG is a procedure in which autologous arteries or veins are used as grafts to bypass coronary arteries that are partially or completely obstructed by atherosclerotic plaque. During the past decade, there has been nearly a 30% decline in CABG procedures, despite abundant evidence to support the effectiveness and safety of the operation.This decline has been accompanied by a corresponding increase in PCI. To date, there have been numerous studies to compare the clinical outcomes between PCI and CABG for patients with CAD. Among them, SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery) trial demonstrated CABG is associated with lower incidence of major adverse cardiac and cerebrovascualr events in patients with high SYNTAX score, compared with PCI. In this regard, the current guidelines recommend that CABG is preferred method for care of stable ischemic heart disease patients with three-vessel or left main coronary artery disease. However, most randomized controlled studies do not reflect the contemporary practice, because they have been performed in the era of bare metal stents or first-generation drug-eluting stent (DES). In addition, there have been limited data regarding the prognostic factors for long-term clinical outcomes in patients undergoing PCI with DES or CABG. Therefore, the investigators sought to compare the clinical outcomes between PCI with DES or CABG, and to identify prognostic factors for long-term clinical outcomes in patients who underwent PCI with DES or CABG.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who suspected ischemic heart disease and underwent CABG or PCI with DES

排除标准

  • Age < 18 years

结局指标

主要结局

Cardiac Death

时间窗: 5-Year after the index procedure

death from cardiac-cause

次要结局

  • All-cause Death(5-Year after the index procedure)
  • MACCE (major adverse cardiac and cerebrovascular accident)(5-Year after the index procedure)
  • Myocardial infarction(5-Year after the index procedure)
  • Target-vessel revascularization(5-Year after the index procedure)
  • Bleeding(5-Year after the index procedure)
  • Cerebrovascular accident(5-Year after the index procedure)
  • Any revascularization(5-Year after the index procedure)

研究者

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

Young Bin Song

Associate Professor

Samsung Medical Center

研究点 (1)

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