Randomized Multicenter Comparison Between Ultrathin-strut Biodegradable Polymer Sirolimuseluting Stents and Durable Polymer Everolimus-eluting Stents for Patients With Acute ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,300
- 试验地点
- 10
- 主要终点
- Target lesion failure, composite of cardiac death, target vessel (Q-wave or non-Q-wave) myocardial re-infarction, or clinically indicated target lesion revascularization
研究概览
简要总结
The objective of the BIOSTEMI ES study is to assess the long-term clinical outcomes with the Orsiro ultrathin-strut biodegradable polymer sirolimus-eluting stent compared to the Xience thin-strut durable polymer everolimus-eluting stent up to 5 years of follow-up among patients with STEMI undergoing primary PCI, enrolled in the BIOSTEMI trial.
详细描述
The objective of the BIOSTEMI ES study is to assess the long-term clinical outcomes with the Orsiro ultrathin-strut biodegradable polymer sirolimus-eluting stent compared to the Xience thin-strut durable polymer everolimus-eluting stent up to 5 years of follow-up among patients with STEMI undergoing primary PCI, enrolled in the BIOSTEMI trial.
- In the BIOSTEMI randomized controlled clinical trial, the Orsiro ultrathin-strut bio degradable polymer sirolimus-eluting stent was found superior to the best-in-class Xience thin-strut durable polymer everolimus-eluting stent with respect to target lesion failure at one-year follow-up among patients with STEMI undergoing primary PCI (Iglesias JF, et al., Lancet 2019). The difference was driven by a lower risk of clinically indicated target lesion revascularization with the Orsiro ultrathin-strut biodegradable polymer sirolimus-eluting stent compared to the Xience thin-strut durable polymer everolimus-eluting stent.
- Importantly, the difference between Orsiro stent and Xience stent accrues over time between one and two years of follow-up.
- As per study protocol, the planned follow-up of patients included in the BIOSTEMI randomized controlled trial was 2 years.
- The long-term clinical benefits the Orsiro ultrathin-strut biodegradable polymer sirolimus-eluting stent over the Xience thin-strut durable polymer everolimus-eluting stent beyond the polymer degradation period remain uncertain.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects that were enrolled in the BIOSTEMI trial (BASEC: 2016-00555),
- •Subject willing and able to provide oral informed consent.
排除标准
- •No specific exclusion criteria.
结局指标
主要结局
Target lesion failure, composite of cardiac death, target vessel (Q-wave or non-Q-wave) myocardial re-infarction, or clinically indicated target lesion revascularization
时间窗: 5 years of follow-up
Clinical assessment
次要结局
- All-cause death(5 years of follow-up)
- Cardiac death(5 years of follow-up)
- Target vessel myocardial re-infarction(5 years of follow-up)
- Clinically indicated and not clinically indicated target lesion revascularization(5 years of follow-up)
- Clinically indicated and not clinically indicated target vessel revascularization(5 years of follow-up)
- Any revascularization(5 years of follow-up)
- Any myocardial infarction (Q-wave and non-Q-wave)(5 years of follow-up)
- Target vessel failure, composite of cardiac death, target vessel myocardial re-infarction, or clinically indicated target vessel revascularization(5 years of follow-up)
- Definite stent thrombosis(5 years of follow-up)
- Definite/probable stent thrombosis(5 years of follow-up)
研究者
IGLESIAS Juan Fernando
PD Dr
University Hospital, Geneva