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.
The current study hypothesizes that IVI-guided PCI will be superior with respect to target vessel failure (TVF), including cardiac death, target-vessel myocardial infarction (TVMI), or clinically-driven TVR when compared with angiography-guided PCI in patients with diabetes mellitus.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,332
Intravascular imaging including intravascular ultrasound or optical coherence tomography.
Deployment of a drug-eluting stent under angiography.
Nanjing First Hospital
Nanjing, Jiangsu, China
RECRUITINGRate of target vessel failure (TVF)
TVF is defined as a composite of cardiac death, target-vessel myocardial infraction, or clinically driven target vessel revascularization
Time frame: At one-year since interventions
Rate of target vessel failure without procedure-related MI
Procedural-related myocardial infarction (PMI) would be excluded from the calculation of TVF
Time frame: At one-year since interventions
Rate of cardiac death
Any death without clear reasons
Time frame: At one-year since interventions
Rate of all-cause death
Any death occurs within one-year follow-up
Time frame: At one-year since interventions
Rate of procedure-related myocardial infarction (PMI)
48 hours after coronary intervention
Time frame: Within 48 h since coronary intervention
Rate of spontaneous myocardial infarction (SMI)
MI happens between 48 h and one-year since coronary intervention
Time frame: Within one-year follow-up
Rate of clinically-driven revascularization
Target vessel revascularization was defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, which included upstream and downstream branches and the target lesion itself.
Time frame: At one-year since coronary artery intervention
Rate of stent thrombosis
Definite or probable stent thrombosis
Time frame: At one-year since coronary artery intervention
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