Intravascular ultrasound (IVUS) serves as a beneficial instrument during percutaneous coronary intervention (PCI) procedures, affording insight into lesion characteristics and stent implantation. The ULTIMATE trial recently evidenced that IVUS-guided Drug-Eluting Stent (DES) implantation notably ameliorated clinical outcomes in all-comers, especially in patients who underwent an optimal procedure defined by IVUS, as opposed to angiography guidance, resonating with findings from the IVUS-XPL study, OCTOBER trial, and RENOVATE COMPLEX PCI trial, further confirmed by more recent IVUS-ACS trial.
Optical coherence tomography (OCT) has a resolution 10 times higher than that of IVUS and can provide valuable information at each step of PCI.
Regrettably, a dearth of prospective, randomized, multicenter trials exists that scrutinize the benefits of IVI-guided as opposed to angiography-guided PCI in patients suffering from diabetes mellitus. However, several trials have presented subgroup analyses reporting the reduction of clinical events by IVUS but not OCT guidance in patients with diabetes mellitus, which served as the foundation for the design of this trial.
Age between 18 ~ 80 years old,
Confirmed diabetes mellitus
Indications for undergoing percutaneous coronary intervention using a drug-eluting stent (Invasive or quantitative fractional flow reserve (QFR or FFR) <0.80)
Silent angina, stable angina, unstable angina, or Non-ST-elevation myocardial infarction
Cardiogenic shock
Previous coronary artery bypass graft (CABG)
Left ventricular ejection fraction < 30%
Requiring oral anticoagulation medications
Parallel
Intravascular imaging-guided PCI
Procedure/SurgeryIntravascular imaging including intravascular ultrasound or optical coherence tomography.
Angiography-guided PCI group
Procedure/SurgeryDeployment of a drug-eluting stent under angiography.
Rate of target vessel failure (TVF)
TVF is defined as a composite of cardiac death, target-vessel myocardial infraction, or clinically driven target vessel revascularization
Rate of target vessel failure without procedure-related MI
Procedural-related myocardial infarction (PMI) would be excluded from the calculation of TVF
Rate of cardiac death
Any death without clear reasons
Rate of all-cause death
Any death occurs within one-year follow-up
Rate of procedure-related myocardial infarction (PMI)
48 hours after coronary intervention
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Nanjing First Hospital, Nanjing Medical University
Lead sponsor
Shanxi Provincial People's Hospital
Collaborator
