A Prospective Multicenter Randomized Trial: Management Tactics for Patients High Risk With Acute Coronary Syndrome Without ST Segment Elevation and Multivessel Coronary Artery Disease
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Federal State Budgetary Institution National Medical Research Center named after academician E.N. Me
- Enrollment
- 460
- Locations
- 1
- Primary Endpoint
- Combined endpoint (death from cardiovascular causes, MI, Stroke, repeated unplanned myocardial revascularization)
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Combined endpoint (death from cardiovascular causes, MI, Stroke, repeated unplanned myocardial revascularization)
Time Frame: 1 year
Death from cardiovascular causes, MI, Stroke, repeated unplanned myocardial revascularization.
target LDL level
Time Frame: 1 year
Achieved target LDL level
Death from any cause
Time Frame: 1 year
a fatal outcome due to any cause or disease
Secondary Outcomes
- 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)
Investigators
Obedinskiy Anton Andreyevich
Obedinskiy Anton Andreyevich
Federal State Budgetary Institution National Medical Research Center named after academician E.N. Me