Management Tactics for Patients High Risk With Acute Coronary Syndrome Without ST Segment Elevation and Multivessel Coronary Artery Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

460 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-29

Study Completion Date

2029-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Syndrome, Acute, Non-ST Elevation, High Risk Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PCI

complete revascularization

Group Type ACTIVE_COMPARATOR

Revascularization

Intervention Type PROCEDURE

revascularization

CABG

Group Type ACTIVE_COMPARATOR

Revascularization

Intervention Type PROCEDURE

revascularization

Interventions

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Revascularization

revascularization

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. 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)
2. 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).
3. 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%).
4. Signed informed consent
5. Age over 18 years.

Exclusion Criteria

1. Myocardial infarction with ST segment elevation
2. Stable angina pectoris
3. Patients with OSN Killip II-IV class
4. Patients required an immediate PCI procedure (e.g. electrical instability)
5. A history of hemorrhagic stroke one year before the procedure
6. Ischemic stroke or TIA in the last 6 weeks
7. The final stage of chronic renal failure requiring dialysis.
8. Preliminary PCI for any other coronary artery lesion within 1 year prior to randomization.
9. Pre-CABG at any time prior to randomization.
10. 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.
11. 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%. 14. Severe degree of COPD

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes