Clinical trial NCT05831085: 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
Official title: A Comparison of Imaging- and Physiology-Guided State-of-the-Art Percutaneous Coronary Intervention and Coronary-Artery Bypass Grafting in Patients With Diabetes and Three-Vessel Coronary Artery Disease: DEFINE-DM Trial (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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2023-04-26
Enrollment: 1360
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: The event rate of major adverse cardiac or cerebrovascular events
timeFrame: 2 years
Secondary outcomes:
measure: The event rate of death from any cause
timeFrame: 2 years
measure: The event rate of myocardial infarction
timeFrame: 2 years
measure: The event rate of stroke
timeFrame: 2 years
measure: The event rate of composite of death from any causes, cardiovascular causes, or noncardiovascular causes
timeFrame: 2 years
measure: The event rate of myocardial infarction
timeFrame: 2 years
measure: The event rate of composite of death or myocardial infarction
timeFrame: 2 years
measure: The event rate of composite of death, myocardial infarction, stroke or repeat revascularization
timeFrame: 2 years
measure: The event rate of stent thrombosis
timeFrame: 2 years
measure: The event rate of symptomatic graft occlusion or stenosis
timeFrame: 2 years
measure: The event rate of bleeding complications
timeFrame: 2 years
measure: The event rate of periprocedural major adverse events
timeFrame: 2 years
measure: Length of hospital stay
timeFrame: 7 days
measure: The event rate of rehospitalization
timeFrame: 7 days
measure: The change of functional class
timeFrame: 1, 6, 12,18, 24 months
measure: The change of angina-related quality of life index by the Seattle Angina Questionnaire [SAQ]
timeFrame: 1, 6, 12,18, 24 months
measure: The change of angina-related quality of life index by the EQ-5D
timeFrame: 1, 6, 12,18, 24 months
measure: The number of anti-anginal medications used
timeFrame: 1, 6, 12,18, 24 months
Other outcomes:
Locations:
city: Hanzhou
country: China
facility: Second Affiliated Hospital of Zhejiang University School of Medicine
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Konyang University Hospital
city: Gangneung
country: Korea, Republic of
facility: Gangneung Asan Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Ilsan
country: Korea, Republic of
facility: National Health Insurance Service Ilsan Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Pusan
country: Korea, Republic of
facility: Dong-A Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Uijeongbu
country: Korea, Republic of
facility: The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Kota Samarahan
country: Malaysia
facility: Sarawak Heart Centre
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
affiliation: Asan Medical Center
name: Seung-jung Park, MD
role: STUDY_CHAIR
References: