跳至主要内容
临床试验/NCT01472705
NCT01472705已完成不适用

Long-Term Comparison of Everolimus-Eluting and Biolimus-Eluting Stents in All-Comer Patients

University of Freiburg1 个研究点 分布在 1 个国家目标入组 814 人开始时间: 2010年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
814
试验地点
1
主要终点
Composite of Death, Myocardial Infarction and Target Vessel Revascularization

研究概览

简要总结

This study sought to investigate safety and efficacy of biolimus-eluting stents (BES) with biodegradable polymer as compared with everolimus-eluting stents (EES) with durable polymer through 3 years of follow-up.

详细描述

A group of 814 consecutive patients undergoing percutaneous coronary intervention (PCI) was enrolled between 2007 and 2010, of which 527 were treated with EES and 287 with BES implantation. Clinical outcome was compared in 200 pairs using propensity score matching. The primary endpoint was a composite of death, myocardial infarction (MI) and target vessel revascularisation (TVR) at two-year follow-up.

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
18 Years 至 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all patients with at least one BES or EES for de novo stenosis

排除标准

  • patients with at least one non-study stent
  • patients with both study stent
  • patients with life expectancy < 3 years

结局指标

主要结局

Composite of Death, Myocardial Infarction and Target Vessel Revascularization

时间窗: up to 24 months

The primary outcome is the above mentioned composite of adverse events in order to measure their cumulative incidence (i.e. the rate of occurrence of such events in the study population over a predefined time periode).

次要结局

  • Cardiovascular death(up to 24 months)
  • Any Revascularization(up to 24 months)

研究者

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

Stéphane Cook, Prof

Principal Investigator

University of Freiburg

研究点 (1)

Loading locations...

相似试验