Clinical trial NCT06279663: Management Tactics for Patients High Risk With Acute Coronary Syndrome Without ST Segment Elevation and Multivessel Coronary Artery Disease
Official title: A Prospective Multicenter Randomized Trial: Management Tactics for Patients High Risk With Acute Coronary Syndrome Without ST Segment Elevation and Multivessel Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Syndrome, Acute, Non-ST Elevation, High Risk Patients
Lead sponsor: Federal State Budgetary Institution National Medical Research Center named after academician E.N. Me
Sponsor class: OTHER_GOV
Collaborators: name: Kemerovo Cardiology Center, Tarasov Roman Sergeevich
name: Tomsk National Research Medical Center of the Russian Academy of Sciences, Ryabov Vyacheslav Valeryevich
First posted: 2024-02-28
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Death from any cause
timeFrame: 1 year
measure: Combined endpoint (death from cardiovascular causes, MI, Stroke, repeated unplanned myocardial revascularization)
timeFrame: 1 year
measure: target LDL level
timeFrame: 1 year
Secondary outcomes:
measure: Myocardial infarction
timeFrame: 1 year
measure: Stroke
timeFrame: 1 year
measure: Repeated unplanned myocardial revascularization
timeFrame: 1 year
measure: Duration of the hospital period
timeFrame: 1 year
measure: Intra/perioperative complications
timeFrame: 1 year
measure: Significant hemorrhagic complications (grade 3 or more on the BARC scale)
timeFrame: 1 year
measure: Questionnaire
timeFrame: 1 year
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Anton
state: Novosibirsk Obl
city: Novosibirsk
country: Russian Federation
facility: Anton
state: Rechkunovskaya Str.
Study officials:
References: