A Prospective Multicenter Randomized Trial: Management Tactics for Patients High Risk With Acute Coronary Syndrome Without ST Segment Elevation and Multivessel Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 460
- 试验地点
- 2
- 主要终点
- Combined endpoint (death from cardiovascular causes, MI, Stroke, repeated unplanned myocardial revascularization)
研究概览
简要总结
The study will include patients with acute coronary syndrome without ST segment elevation and multivessel CA lesion, who are subject to surgical treatment according to KG data (Syntax Score 23 - 32 points with significant damage to the anterior descending artery and/or trunk of the left coronary artery). The patient should be suitable for both CABG and PCI (confirmed by an X-ray surgeon and a cardiac surgeon). An X-ray surgeon and a cardiac surgeon, within the framework of planning the volume of revascularization, strives for the fullest feasible volume. Complete myocardial revascularization (that is, the desire for the absence of hemodynamically significant coronary arteries after revascularization, with a diameter of > 2.5 mm, that is, residual coronary artery stenosis of no more than 60%). Thus, patients will be randomized into groups in a ratio of 1:1. Each group will need to include 230 patients (a total of 460). In the main group, revascularization will be performed by PCI, in the control group by CABG.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Acute coronary syndrome without ST segment elevation of high risk: unstable angina pectoris or myocardial infarction requiring revascularization within 24 hours based on the risk of an unfavorable outcome (increase or decrease in the concentration of cardiac troponin in the blood that meet the criteria of MI; dynamic ST segment displacement or changes in T; risk on the GRACE scale >140 points)
- •The patient is suitable for both CABG and PCI, confirmed by an interventional cardiologist and surgeon (multivessel lesion with a Sintax score of 23-32 points with significant damage to the anterior descending artery and/or trunk of the left coronary artery).
- •Complete myocardial revascularization (that is, the desire for the absence of hemodynamically significant coronary arteries after revascularization, with a diameter of > 2.5 mm, that is, residual coronary artery stenosis of no more than 60%).
- •Signed informed consent
- •Age over 18 years.
排除标准
- •Myocardial infarction with ST segment elevation
- •Stable angina pectoris
- •Patients with OSN Killip II-IV class
- •Patients required an immediate PCI procedure (e.g. electrical instability)
- •A history of hemorrhagic stroke one year before the procedure
- •Ischemic stroke or TIA in the last 6 weeks
- •The final stage of chronic renal failure requiring dialysis.
- •Preliminary PCI for any other coronary artery lesion within 1 year prior to randomization.
- •Pre-CABG at any time prior to randomization.
- •The need for concomitant cardiac surgery, except for CABG (for example, valve surgery, aortic repair, etc.). Patients who require additional surgery (cardiological or extra-cardiac) for 1 year.
- •Non-cardiac concomitant diseases with a life expectancy of less than 1 year (for example, oncological diseases).
- •13. The left ventricular ejection fraction is less than 40%.
- •Severe degree of COPD
结局指标
主要结局
Combined endpoint (death from cardiovascular causes, MI, Stroke, repeated unplanned myocardial revascularization)
时间窗: 1 year
Death from cardiovascular causes, MI, Stroke, repeated unplanned myocardial revascularization.
target LDL level
时间窗: 1 year
Achieved target LDL level
Death from any cause
时间窗: 1 year
a fatal outcome due to any cause or disease
次要结局
- Questionnaire(1 year)
- Myocardial infarction(1 year)
- Duration of the hospital period(1 year)
- Repeated unplanned myocardial revascularization(1 year)
- Stroke(1 year)
- Intra/perioperative complications(1 year)
- Significant hemorrhagic complications (grade 3 or more on the BARC scale)(1 year)
研究者
Obedinskiy Anton Andreyevich
Obedinskiy Anton Andreyevich
Federal State Budgetary Institution National Medical Research Center named after academician E.N. Me