Intravascular imaging-guided versus angiography-guided percutaneous coronary intervention in patients with diabetes mellitus: Rationale and design of an international, multicenter, randomized IVI-DIABETES trial.

Background: Intravascular imaging (IVI)- guided percutaneous coronary intervention (PCI) can improve clinical outcomes compared with angiography guidance in patients with complex lesions or acute coronary syndrome. However, the impact of this approach among diabetic patients remains unknown.

Trial Design: IVI-DIABETES trial is an investigator-initiated, prospective, international, multicenter, randomized trial, involving at least 30 sites, aiming to enroll 1,332 diabetic patients with obstructive coronary artery disease undergoing PCI. All enrolled patients are randomly assigned in a 1:1 fashion to undergo IVI- guided PCI or angiography- guided PCI. The choice between intravascular ultrasound or optical coherence tomography is at the discretion of the operator. The primary endpoint is target vessel failure (TVF) at 12 months, defined by the composite of cardiac death, target vessel myocardial infarction (MI), or clinically-driven target vessel revascularization. The major secondary endpoint is TVF without procedure-related MI. After hospital discharge, follow-up is conducted through clinical visits or telephone contact at 1, 6, and 12 months. The follow-up will continue annually until 5 years after the index procedure to assess the long-term outcomes.

Conclusion: IVI-DIABETES trial is the first study designed to investigate the clinical efficacy and safety of IVI-guided PCI in diabetic patients compared to angiography-guided PCI.

Trial Registration: clinicaltrials.gov, NCT06380868.