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

Not Applicable

Recruiting

• Conditions: Coronary Syndrome, Acute, Non-ST Elevation, High Risk Patients
• Interventions: Procedure: Revascularization

• Registration Number: NCT06279663
• Lead Sponsor: Federal State Budgetary Institution National Medical Research Center named after academician E.N. Me

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-15
• Study First Submitted QC: 2024-02-22
• Study First Posted: 2024-02-28
• Study Start: 2024-02-29
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13
• Primary Completion: 2028-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 460

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).

12. The left ventricular ejection fraction is less than 40%. 14. Severe degree of COPD

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCI	Revascularization	complete revascularization
CABG	Revascularization	-

Primary Outcome Measures

Name	Time	Method
Combined endpoint (death from cardiovascular causes, MI, Stroke, repeated unplanned myocardial revascularization)	1 year	Death from cardiovascular causes, MI, Stroke, repeated unplanned myocardial revascularization.
target LDL level	1 year	Achieved target LDL level
Death from any cause	1 year	a fatal outcome due to any cause or disease

Secondary Outcome Measures

Name	Time	Method
Questionnaire	1 year	SF-36 Quality of Life Questionnaire and Rose Questionn
Myocardial infarction	1 year	Myocardial infarction (Fourth universal definition of myocardial infarction (2018))
Duration of the hospital period	1 year	the number of bed days that the patient spent in the clinic in connection with an index event and/or complications arising from the underlying, concomitant diseases, as well as in connection with the treatment.
Repeated unplanned myocardial revascularization	1 year	any type of repeated myocardial revascularization by endovascular or cardiac surgery performed in the time period after index revascularization;
Stroke	1 year	clinically verified acute cerebrovascular accident of any etiology (hemorrhagic or ischemic)
Intra/perioperative complications	1 year	Any intra/perioperative complications (MI, Stroke, hemorrhagic complication, )
Significant hemorrhagic complications (grade 3 or more on the BARC scale)	1 year	any bleeding that occurred during or after the index revascularization of the myocardium, leading to a clinically significant decrease in hemoglobin levels, requiring hemotransfusion and/or surgical methods of hemostasis, artery dissection, shunt thrombosis, and other

Trial Locations

Locations (1)

Anton; 🇷🇺 Novosibirsk, Rechkunovskaya Str., Russian Federation