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

NCT05831085 | Recruiting DMC

• 1 other identifier: AMCCV2023-03
• Study Type: interventional
• Target: 1,500
• Locations: 9 countries
• Sites: 27

Brief Summary

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

Conditions

Coronary Artery Stenosis

Keywords

Multivessel Coronary Artery Disease; state of the art; State-of-the-Art Percutaneous Coronary Intervention; Coronary-Artery Bypass Grafting; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• The event rate of major adverse cardiac or cerebrovascular events

  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.

  2 years

Secondary Outcomes (19)

• The event rate of death from any cause

  5 years

• The event rate of myocardial infarction

  5 years

• The event rate of repeat revascularization

  5 years

• The event rate of stroke

  5 years

• The event rate of composite of death from any causes, cardiovascular causes, or noncardiovascular causes

  5 years

Study Arms (2)

Imaging- and Physiology-Guided State-of-the-Art Percutaneous Coronary Intervention

EXPERIMENTAL

Procedure: State-of-the-Art Percutaneous Coronary Intervention

Coronary-Artery Bypass Grafting

ACTIVE COMPARATOR

Procedure: standard CABG

Interventions

State-of-the-Art Percutaneous Coronary Intervention PROCEDURE

supported by intracoronary imaging (e.g., intravascular ultrasound \[IVUS\] or optical coherence tomography \[OCT\]), intracoronary physiology (e.g., fractional flow reserve \[FFR\] or instantaneous wave-free ratio \[iFR\]), contemporary metallic DES (durable polymer everolimus-eluting stents; XIENCE family stent system, Abbott Vascular), guideline-directed optimal medical therapy \[GDMT\] with advanced cardiovascular (e.g., high-dose statin and advanced strategy of antiplatelet regimens) and anti-diabetic medications \[e.g., a sodium-glucose cotransporter \[SGLT\]-2 inhibitors or Glucagon-like peptide-1 \[GLP-1\] agonists) in patients with type 2 diabetes and three-vessel coronary artery disease (CAD) (not involving left main)

Imaging- and Physiology-Guided State-of-the-Art Percutaneous Coronary Intervention

standard CABG PROCEDURE

Coronary-Artery Bypass Grafting

Coronary-Artery Bypass Grafting

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject must be ≥20 years of age with angina and/or evidence of myocardial ischemia.
• 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% \[48 mmol/mol\]).
• 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 equivalently amenable to revascularization by means of either PCI or CABG as determined by the Heart Team at the trial site.
• 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.

You may not qualify if:

• Unprotected left main coronary artery disease.
• 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).
• Recent ST-elevation myocardial infarction(\<5 days prior to randomization).
• Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support.
• Severe left ventricular dysfunction (ejection fraction \<30%).
• 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.
• Contraindication or inability to take aspirin or P2Y12 inhibitors (clopidogrel, ticagrelor, or prasugrel) for at least 6 months.
• Prior CABG.
• Extremely calcified or tortuous vessels precluding FFR measurement or intracoronary imaging evaluation.
• More than one major epicardial vessel which is chronically occluded; enrollment of 1 Chronic total occlusion lesion is allowed.
• Subjects requiring or who may require additional surgery (cardiac or noncardiac) within 1 year.
• End-stage renal disease requiring renal replacement therapy.
• Liver cirrhosis.
• Pregnant and/or lactating women.
• Concurrent medical condition with a limited life expectancy of less than 2 years.

Sponsors & Collaborators

• Duk-Woo Park, MD: lead
• CardioVascular Research Foundation, Korea: collaborator

Study Sites (27)

Palo Alto VA Medical Center

Palo Alto, California, 94304, United States

NOT YET RECRUITING

Fuwai Hospital, Chinese Academy of Medical Sciences (CAMS)

Beijing, China

NOT YET RECRUITING

Second Affiliated Hospital of Zhejiang University School of Medicine

Hanzhou, China

RECRUITING

Medanta - The Medicity

Gurugram, India

RECRUITING

Fortis Escorts Heart Institute

New Delhi, India

NOT YET RECRUITING

Sarawak Heart Centre

Kota Samarahan, Malaysia

RECRUITING

University Clinical Center of Serbia

Belgrade, Serbia

NOT YET RECRUITING

National Heart Centre Singapore (NHCS)

Singapore, Singapore

NOT YET RECRUITING

Daegu Catholic University Medical Center

Daegu, South Korea

NOT YET RECRUITING

Keimyung University Dongsan Medical Center

Daegu, South Korea

RECRUITING

Yeungnam University Medical Center

Daegu, South Korea

NOT YET RECRUITING

Chungnam National University Hospital

Daejeon, South Korea

NOT YET RECRUITING

Konyang University Hospital

Daejeon, South Korea

WITHDRAWN

Gangneung Asan Hospital

Gangneung, South Korea

NOT YET RECRUITING

Chonnam National University Hospital

Gwangju, South Korea

RECRUITING

National Health Insurance Service Ilsan Hospital

Ilsan, South Korea

RECRUITING

Gachon University Gil Hospital

Incheon, South Korea

NOT YET RECRUITING

Dong-A Medical Center

Pusan, South Korea

RECRUITING

Asan Medical Center

Seoul, South Korea

RECRUITING

Hanyang University Seoul Hospital

Seoul, South Korea

NOT YET RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

SNU Boramae Medical Center

Seoul, South Korea

NOT YET RECRUITING

The Catholic University of Korea, St. Vincent's Hospital

Suwon, South Korea

NOT YET RECRUITING

The Catholic University of Korea, Uijeongbu ST. Mary's Hospital

Uijeongbu-si, South Korea

RECRUITING

Ulsan University Hospital

Ulsan, South Korea

RECRUITING

National Taiwan University Hospital

Taipei, Taiwan

NOT YET RECRUITING

Siriraj Hospital

Bangkok, Thailand

RECRUITING

MeSH Terms

Conditions

Coronary Stenosis; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Seung-jung Park, MD

  Asan Medical Center

  STUDY CHAIR

Central Study Contacts

Jung-hee Ham, Project manager

CONTACT

82-2-3010-4728; cvcrc5@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Cardiology, Asan Medical Center Heart Institute, Valvular Heart Disease Center, Ischemic Heart Disease Center

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: April 26, 2023
• Study Start: June 14, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

US (1); CN (2); SE (1); TH (1); TW (1); SG (1); IN (2); KR (17); MY (1)