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
State-of-the-Art Percutaneous Coronary Intervention: 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)
standard CABG: Coronary-Artery Bypass Grafting
Study 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).
Eligibility
Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
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 equivalently 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.
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 prasugrel) 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.
Primary outcome measure(s)
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.
Trial sites (39)
Facility
City
Region
Status
Palo Alto VA Medical Center
Palo Alto
California
Recruiting
Victorian Heart Institute
Clayton
Australia
Recruiting
Fuwai Hospital, Chinese Academy of Medical Sciences (CAMS)
Beijing
China
Recruiting
Second Affiliated Hospital of Zhejiang University School of Medicine
Hanzhou
China
Recruiting
Queen Mary Hospital
Hong Kong
Hong Kong
Recruiting
Mody Harvard Cardiac Institute
Bathinda
India
Recruiting
Medanta - The Medicity
Gurugram
India
Recruiting
Fortis Escorts Heart Institute
New Delhi
India
Recruiting
Tsuchiura Kyodo Hospital
Tsuchiura
Japan
Recruiting
Pauls Stradins Clinical University Hospital
Riga
Latvia
Recruiting
Vilnius University Hospital Santaros Klinikos
Vilnius
Lithuania
Recruiting
Sarawak Heart Centre
Kota Samarahan
Malaysia
Recruiting
University Clinical Center of Serbia
Belgrade
Serbia
Recruiting
National Heart Centre Singapore (NHCS)
Singapore
Singapore
Recruiting
Bucheon Sejong Hospital
Bucheon-si
South Korea
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
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
Seoul university Bundang hospital
Seongnam-si
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 Univ. of Korea Seoul St. Mary's hospital
Seoul
South Korea
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
Pusan National University Yangsan Hospital
Yangsan
South Korea
Recruiting
National Taiwan University Hospital
Taipei
Taiwan
Recruiting
Siriraj Hospital
Bangkok
Thailand
Recruiting
Siriraj Hospital
Bangkok
Thailand
Recruiting
Srinagarind Hospital
Khon Kaen
Thailand
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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