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

Conditions

• Coronary Artery Stenosis

Eligibility Criteria

Sex

ALL

Age

20 Years - N/A

Healthy Volunteers

Not accepted

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)
• standard CABG — PROCEDURE
  Coronary-Artery Bypass Grafting

Study Details

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).

Key Dates

Start date

Jun 14, 2024

Status verified

Dec 2025

Primary completion

Jun 30, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

1,500 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Imaging- and Physiology-Guided State-of-the-Art Percutaneous Coronary Intervention
• Active Comparator: Coronary-Artery Bypass Grafting

Primary Outcome Measure

The event rate of major adverse cardiac or cerebrovascular events [ Time Frame: 2 years ]

Central Contacts

• Jung-hee Ham, Project manager
  82-2-3010-4728
  [email protected]

Locations (1)

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