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

Coronary Artery Stenosis Clinical Trial

— DEFINE-DM  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05831085
• Other study ID #: AMCCV2023-03
• Status: Recruiting
• Phase: Phase 4
• Start date: June 14, 2024
• Est. completion date: December 2027

Study information

• Verified date: June 2024
• Source: Asan Medical Center
• Contact: Jung-hee Ham, Project manager
• Phone: 82-2-3010-4728
• Email: cvcrc5[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1360
• Est. completion date: December 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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]) (17).

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, except for observational registries

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Stenosis
• Coronary Disease
• Coronary Stenosis
• Diabetes Mellitus
• Myocardial Ischemia

Intervention

Procedure:
• 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 drug-eluting stents (DES), guideline-directed optimal medical therapy [GDMT] with advanced cardiovascular and anti-diabetic medications [e.g., a sodium-glucose cotransporter [SGLT]-2 inhibitors]) in patients with type 2 diabetes and three-vessel coronary artery disease (CAD) (not involving left main)
• standard CABG
Coronary-Artery Bypass Grafting

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Duk-Woo Park, MD	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The event rate of death from any cause		2 years
Secondary	The event rate of myocardial infarction		2 years
Secondary	The event rate of stroke		2 years
Secondary	The event rate of composite of death from any causes, cardiovascular causes, or noncardiovascular causes		2 years
Secondary	The event rate of myocardial infarction	any, spontaneous or procedural	2 years
Secondary	The event rate of composite of death or myocardial infarction		2 years
Secondary	The event rate of composite of death, myocardial infarction, stroke or repeat revascularization		2 years
Secondary	The event rate of stent thrombosis	by an Academic Research Consortium (ARC) definition	2 years
Secondary	The event rate of symptomatic graft occlusion or stenosis		2 years
Secondary	The event rate of bleeding complications	BARC (Bleeding Academic Research Consortium) criteria	2 years
Secondary	The event rate of periprocedural major adverse events	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.	2 years
Secondary	Length of hospital stay		7 days
Secondary	The event rate of rehospitalization	any, cardiac, or noncardiac causes	7 days
Secondary	The change of functional class	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.	1, 6, 12,18, 24 months
Secondary	The change of angina-related quality of life index by the Seattle Angina Questionnaire [SAQ]	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.	1, 6, 12,18, 24 months
Secondary	The change of angina-related quality of life index by the EQ-5D	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.	1, 6, 12,18, 24 months
Secondary	The number of anti-anginal medications used		1, 6, 12,18, 24 months