Diabetes-Centered Evaluation of Revascularization Strategy of Functional and Imaging-CombiNEd State-of-the-Art Percutaneous Coronary Intervention or Coronary-Artery Bypass Grafting in Patients With Diabetes Mellitus and Multivessel Coronary Artery Disease

Not Applicable

Recruiting

• Conditions: Coronary Artery Stenosis
• Interventions: Procedure: standard CABG; Procedure: State-of-the-Art Percutaneous Coronary Intervention

• Registration Number: NCT05831085
• Lead Sponsor: Duk-Woo Park, MD

Brief Summary

The objective of this randomized study was to compare outcomes of imaging-and physiology-guided state-of-the-art ercutaneous coronary intervention (PCI) to coronary artery bypass grafting (CABG) in patients with diabetes and three-vessel CAD (not involving left main).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-04
• Study First Submitted QC: 2023-04-14
• Study First Posted: 2023-04-26
• Study Start: 2024-06-14
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-05
• Primary Completion: 2027-06
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1360

Inclusion Criteria

1. The subject must be ≥20 years of age with angina and/or evidence of myocardial ischemia.
2. Patients with type 2 diabetes based on the need for treatment with insulin or oral hypoglycemic drugs or a confirmed elevated blood glucose level (fasting plasma glucose elevation on >1 occasion of ≥126 mg/dL [7.0 mmol/L] or 2-h postprandial of ≥200 mg/dL [11.1 mmol/L] during oral glucose tolerance test or random plasma glucose of ≥200 mg/dL [11.1 mmol/L] with classic symptoms of hyperglycemia or hyperglycemic crisis or HbA1C ≥6.5% [48 mmol/mol]).
3. Significant three-vessel CAD (defined as ≥ 50% diameter stenosis [DS] by visual estimation in each of the three major epicardial vessels or major side branches but not involving the left main coronary artery) and amenable to revascularization by means of either PCI or CABG as determined by the Heart Team at the trial site.
4. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria

1. Unprotected left main coronary artery disease requiring revascularization.
2. The presence of complex coronary disease anatomy or lesion characteristics or other cardiac condition(s) which leads the participating interventional cardiologist to believe that PCI is not suitable (i.e. the subject should be managed with CABG or medical therapy alone).
3. Recent ST-elevation myocardial infarction(<5 days prior to randomization).
4. Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support.
5. Severe left ventricular dysfunction (ejection fraction <30%).
6. Requirement for other cardiac or non-cardiac surgical procedure (e.g., valve replacement, aorta surgery, or carotid revascularization). However, a maze procedure or pulmonary vein isolation is allowed.
7. Contraindication or inability to take aspirin or P2Y12 inhibitors (clopidogrel, ticagrelor, or clopidogrel) for at least 6 months.
8. Prior CABG.
9. Extremely calcified or tortuous vessels precluding FFR measurement or intracoronary imaging evaluation.
10. More than one major epicardial vessel which is chronically occluded; enrollment of 1 Chronic total occlusion lesion is allowed.
11. Subjects requiring or who may require additional surgery (cardiac or noncardiac) within 1 year.
12. End-stage renal disease requiring renal replacement therapy.
13. Liver cirrhosis.
14. Pregnant and/or lactating women.
15. Concurrent medical condition with a limited life expectancy of less than 2 years.
16. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period. However, where at least one or more conditions are satisfied, it could be an exception according to an investigator's discretion;

1. Participated in the observational study expected no effect on the safety and/or effectiveness evaluation of this trial.

2. Screening failed before any interventional factor is involved.

3. Participated in academic trials like strategic comparison studies conducted under standard therapy provided that there is no additional risk or a specific procedure to a subject and no interference between this trial and other studies.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coronary-Artery Bypass Grafting	standard CABG	-
Imaging- and Physiology-Guided State-of-the-Art Percutaneous Coronary Intervention	State-of-the-Art Percutaneous Coronary Intervention	-

Primary Outcome Measures

Name	Time	Method
The event rate of major adverse cardiac or cerebrovascular events	2 years	Major adverse cardiac or cerebrovascular events (MACCE) were defined as a composite of hard clinical endpoints of death from any causes, myocardial infarction, or stroke.

Secondary Outcome Measures

Name	Time	Method
The event rate of composite of death or myocardial infarction	2 years
The event rate of composite of death, myocardial infarction, stroke or repeat revascularization	2 years
The event rate of death from any cause	2 years
The event rate of stroke	2 years
The event rate of composite of death from any causes, cardiovascular causes, or noncardiovascular causes	2 years
The event rate of symptomatic graft occlusion or stenosis	2 years
The change of functional class	1, 6, 12,18, 24 months	Assessed by The Canadian Cardiovascular Society (CCS) Angina Score Classification.; The minimum and maximum values are 1 and 4 respectively. A higher score of CCS angina score classification means severe exertional angina.
The change of angina-related quality of life index by the Seattle Angina Questionnaire [SAQ]	1, 6, 12,18, 24 months	The SAQ is a disease-specific patient-reported outcome (PRO) with 5 domains.; The minimum and maximum values are 0 and 100 respectively. A lower score represents poor health status and a high score represents good health status.
The number of anti-anginal medications used	1, 6, 12,18, 24 months
The event rate of myocardial infarction	2 years	any, spontaneous or procedural
The event rate of stent thrombosis	2 years	by an Academic Research Consortium (ARC) definition
The event rate of bleeding complications	2 years	BARC (Bleeding Academic Research Consortium) criteria
The event rate of periprocedural major adverse events	2 years	Periprocedural major adverse events means major arrhythmia, any unplanned surgery or therapeutic radiologic procedure, development of acute renal failure, sternal wound dehiscence, infection requiring antibiotics, prolonged intubation (\>48 hours), post-pericardiotomy syndrome, etc.
Length of hospital stay	7 days
The event rate of rehospitalization	7 days	any, cardiac, or noncardiac causes
The change of angina-related quality of life index by the EQ-5D	1, 6, 12,18, 24 months	EQ-5D is a standardised measure of health-related quality of life developed by the EuroQol Group.; The minimum and maximum values are 5 and 15 respectively. A higher score of EQ-5D means a low quality of life.

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of