Management Tactics for Patients High Risk With Acute Coronary Syndrome Without ST Segment Elevation and Multivessel Coronary Artery Disease (NSTE-ACSMT)

A Prospective Multicenter Randomized Trial: Management Tactics for Patients High Risk With Acute Coronary Syndrome Without ST Segment Elevation and Multivessel Coronary Artery Disease

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 Overview

• Status: Recruiting
• Conditions: Coronary Syndrome, Acute, Non-ST Elevation, High Risk Patients
• Intervention / Treatment: Procedure: Revascularization

• Study Type: Interventional
• Enrollment (Estimated): 460
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Novosibirsk Obl
    • Novosibirsk, Novosibirsk Obl, Russian Federation, 630055
      • Recruiting
      • Anton
      • Contact: Anton Obedinskiy, 1; Phone Number: 1 +73833476099; Email: a_obedinskij@meshalkin.ru
  • Rechkunovskaya Str.
    • Novosibirsk, Rechkunovskaya Str., Russian Federation, 630055
      • Recruiting
      • Anton
      • Contact: Anton Obedinskiy; Phone Number: 89139322885; Email: a_obedinskij@meshalkin.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CABG	Procedure: Revascularization; revascularization
Active Comparator: PCI; complete revascularization	Procedure: Revascularization; revascularization

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial infarction	Myocardial infarction (Fourth universal definition of myocardial infarction (2018))	1 year
Stroke	clinically verified acute cerebrovascular accident of any etiology (hemorrhagic or ischemic)	1 year
Repeated unplanned myocardial revascularization	any type of repeated myocardial revascularization by endovascular or cardiac surgery performed in the time period after index revascularization;	1 year
Duration of the hospital period	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.	1 year
Intra/perioperative complications	Any intra/perioperative complications (MI, Stroke, hemorrhagic complication, )	1 year
Significant hemorrhagic complications (grade 3 or more on the BARC scale)	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	1 year
Questionnaire	SF-36 Quality of Life Questionnaire and Rose Questionn	1 year

Collaborators and Investigators

• Sponsor: Federal State Budgetary Institution National Medical Research Center named after academician E.N. Me
• Collaborators: Kemerovo Cardiology Center, Tarasov Roman Sergeevich; Tomsk National Research Medical Center of the Russian Academy of Sciences, Ryabov Vyacheslav Valeryevich

Study record dates

Study Major Dates

• Study Start (Actual): February 29, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: NSTE-ACS Multivessel Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No