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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
Sponsor: Duk-Woo Park, MD
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).
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)
Key Details
Gender
All
Age Range
20 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1500
Start Date
2024-06-14
Completion Date
2027-12
Last Updated
2025-12-30
Healthy Volunteers
No
Conditions
Interventions
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
Locations (27)
Palo Alto VA Medical Center
Palo Alto, California, United States
Fuwai Hospital, Chinese Academy of Medical Sciences (CAMS)
Beijing, China
Second Affiliated Hospital of Zhejiang University School of Medicine
Hanzhou, China
Medanta - The Medicity
Gurugram, India
Fortis Escorts Heart Institute
New Delhi, India
Sarawak Heart Centre
Kota Samarahan, Malaysia
University Clinical Center of Serbia
Belgrade, Serbia
National Heart Centre Singapore (NHCS)
Singapore, Singapore
Daegu Catholic University Medical Center
Daegu, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Yeungnam University Medical Center
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Konyang University Hospital
Daejeon, South Korea
Gangneung Asan Hospital
Gangneung, South Korea
Chonnam National University Hospital
Gwangju, South Korea
National Health Insurance Service Ilsan Hospital
Ilsan, South Korea
Gachon University Gil Hospital
Incheon, South Korea
Dong-A Medical Center
Pusan, South Korea
Asan Medical Center
Seoul, South Korea
Hanyang University Seoul Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
SNU Boramae Medical Center
Seoul, South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, South Korea
The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
Uijeongbu-si, South Korea
Ulsan University Hospital
Ulsan, South Korea
National Taiwan University Hospital
Taipei, Taiwan
Siriraj Hospital
Bangkok, Thailand