The Nordic-Baltic Heart Team Initiative for Improved Long-term Coronary Artery Revascularization Outcome in Patients With Proximal Left Descending Coronary Artery (LAD) Lesion. NOBLE LAD
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- All-cause mortality
研究概览
简要总结
The Nordic-Baltic Heart Team Initiative for improved long-term coronary artery revascularization outcome compares quality of life and survival after coronary bypass grafting (CABG) vs. percutaneous coronary intervention (PCI) in patients with 1-vessel disease and proximal stenosis of the anterior descending artery (LAD/in patients with isolated proximal left descending coronary artery (LAD) lesion
详细描述
It is not clear how operable 1-VD patients with stable or stabilized coronary artery disease involving a pLAD lesion should be treated to optimize long-term survival and quality of life.
According to recent European guidelines, significant pLAD disease may be treated by PCI or by CABG. This recommendation is based on two meta-analyses including 1.210 and 1.952 randomized and non-randomized patients. Generally, the patients were followed for 4-5 years. The analyses reported similar rates of mortality, MI and stroke, but more repeat revascularizations after PCI. Only one study including129 patients provided more than 5-year follow-up. Thus, the there is limited documentation for long-term effect of PCI vs. surgical re-vascularization in pLAD disease.
The American 2014 Guidelines on coronary revascularization recommends CABG for improved survival in patients with solitary proximal LAD stenosis. CABG
The angiographic 90% LIMA patency rate after 1, 2 and 3 decades is well described and suggestive of a survival benefit of surgical revascularization.
Therefore, there is scientific background for an CABG LIMA-to-LAD vs. PCI comparison in 1-VD patients with a pLAD lesion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The clinical outcomes will be assessed by an independent event committee with no knowledge of treatment allocation.
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
- •Heart Team decision on treatment
- •1-VD patients with stable coronary artery disease or stabilized unstable angina pectoris/NSTEMI or silent ischemia Proximal LAD (pLAD) stenosis (>90% by visual assessment or FFR <80% The lesion may be treated by both PCI and surgery
排除标准
- •ST-elevation myocardial infarction within 24 hours. Expected survival <1 year, because of high age or severe cardiac or non-cardiac disease.
- •Significant LM disease. Earlier CABG. PCI within 3 months. Significant valvular heart disease. Renal failure on dialysis Earlier disabling stroke Relative or absolute contraindication to dual antiplatelet therapy. Allergy relevant to the study treatments. Age < 18 years. Study required information and consent suboptimal or impossible.
结局指标
主要结局
All-cause mortality
时间窗: 10 years
Death of any cause
Quality of life
时间窗: 1 year
By SF 12 and Seatle Angina Questionaire
MACCE
时间窗: 1 year
Major cardiac and cerebral adverse events (myocardial infarction, stroke, revascularization, death)
次要结局
- All-cause death(1, 2, 3, 5 and 10 years)
- Cardiac death(1, 2, 3, 5 and 10 years)
- Spontaneous myocardial infarction(1, 2, 3, 5 and 10 years)
- Procedure related myocardial infarction(1, 2, 3, 5 and 10 years)
- Major stroke, minor stroke and al stroke(1, 2, 3, 5 and 10 years)
- Angina(1, 2, 3, 5 and 10 years)
- Heart failure(1, 2, 3, 5 and 10 years)
- Stent thrombosis(1, 2, 3, 5 and 10 years)
研究者
Leif Thuesen
Senior interventional cardiologist
Aalborg University Hospital