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临床试验/NCT02410993
NCT02410993Unknown不适用

Current Treatment Strategy of Patients With Multivessel Disease or Left Main Coronary Artery Disease Indicated for Coronary Artery Bypass Graft Surgery

Yonsei University1 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
2,500
试验地点
1
主要终点
Proportion of patients treated with PCI or medical treatment despite of recommendation for CABG surgery

研究概览

简要总结

According to 2011 ACCF/AHA guideline and 2014 ESC/EACTS guideline, CABG surgery was recommended for three-vessel coronary artery disease and left main coronary artery disease in the patients with stable ischemic heart disease as class I. 2-VD with proximal left anterior descending artery stenosis was also indicated for CABG surgery as class I recommendation. However, many patients have been recommended for PCI by catheterization laboratory cardiologist; 46% and 93% in the only-CABG candidates and both CABG and PCI candidates, retrospectively, defined by previous ACC/AHA guideline. Although the discordance between real practice in catheterization laboratory and guideline would be adjusted by recently updated guideline. The revascularization strategy for patients with 3-VD/LMD in real practice have been getting toward more PCI and less CABG surgery. In this study, we will identify the rate of CABG candidates who were treated with PCI or medical treatment instead of CABG surgery in different from current guideline. We are also going to compare two treatment strategies CABG surgery vs. PCI with 2nd generation DES regarding clinical outcomes.

研究设计

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

入排标准

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

入选标准

  • Patients ≥ 19 years old
  • Left main disease, three-vessel disease or two-vessel disease with proximal LAD stenosis.

排除标准

  • Previous PCI within 1 year
  • Previous sternotomy
  • Primary PCI for STEMI
  • Contraindication or hypersensitivity to anti-platelet medications or contrast media
  • Planned need for concomitant other cardiac surgery (eg, valve surgery or resection of aortic or left ventricular aneurysm, etc)
  • Pregnant women or women with potential childbearing
  • Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
  • Inability to understand or read the informed content

结局指标

主要结局

Proportion of patients treated with PCI or medical treatment despite of recommendation for CABG surgery

时间窗: 1 month (After the revascularization strategy was finally decided)

次要结局

  • Reason of ineligibility for CABG surgery(1 month (After the revascularization strategy was finally decided))
  • the composite of major cardiac and cerebrovascular event (MACCE)(1 year follow up after revascularization)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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