Long-term Follow-up of a Randomized Comparison of Percutaneous Coronary Intervention Versus Coronary Artery Bypass Surgery in Unprotected Left Main Disease
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 201
- 试验地点
- 4
- 主要终点
- All-cause death
研究概览
简要总结
This is a long-term follow-up of a completed clinical trial which compared percutaneous coronary intervention (PCI) using sirolimus-eluting stents and coronary artery bypass grafting (CABG) in patients with unprotected left main coronary artery disease.
The purpose of the study is to obtain retrospective long-term data on clinical outcome of the study population.
详细描述
The randomized multicenter, open-label trial "Percutaneous Coronary Intervention (PCI) With Drug-Eluting Stents (DES) Versus Coronary Artery Bypass Graft (CABG) for Patients With Significant Left Main Stenosis" was conducted at 4 tertiary care centers in Germany. 201 patients with unprotected left main stem stenosis (≥50%) with or without additional multivessel coronary artery disease were enrolled in a 1:1 ratio from July 2003 through February 2009. Results were published: https://pubmed.ncbi.nlm.nih.gov/21272743/
Long-term follow-up will be performed by a structured telephone interview using a standardized questionnaire by an interviewer blinded to treatment allocation. Wherever possible, data will be completed and verified by health care records. Retrospective data of the underlying randomized study will be included in data analysis.
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
- •alive participants of underlying study who give their consent to participate
- •deceased participants of underlying study
排除标准
- •alive participants of underlying study who do not consent
结局指标
主要结局
All-cause death
时间窗: approximately 15 years after procedure
further categorized into cardiovascular, noncardiovascular, and undetermined deaths
次要结局
- composite secondary endpoint(approximately 15 years after procedure)