Intravascular Imaging-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus: the Muticenter, Randomized, Prospective IVI-DIABETES Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
- Enrollment
- 1332
- Locations
- 1
- Primary Endpoint
- Rate of target vessel failure (TVF)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Shaoliang Chen, MD
Professor
Nanjing First Hospital, Nanjing Medical University
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Cardiogenic shock
- •Previous coronary artery bypass graft (CABG)
- •Left ventricular ejection fraction \< 30%
- •Requiring oral anticoagulation medications
- •Any planned surgery within 12 months
- •Severe chronic kidney disease defined as an estimated glomerular filtration rate (eGFR) \< 20 ml/min/1.73m2
- •Platelet count \< 100,000 mm3
- •Contraindication to study medications or metal
- •Women of childbearing potential
- •Life expectancy \< 1 year
Outcomes
Primary Outcomes
Rate of target vessel failure (TVF)
Time Frame: At one-year since interventions
TVF is defined as a composite of cardiac death, target-vessel myocardial infraction, or clinically driven target vessel revascularization
Secondary Outcomes
- Rate of target vessel failure without procedure-related MI(At one-year since interventions)
- Rate of procedure-related myocardial infarction (PMI)(Within 48 h since coronary intervention)
- Rate of cardiac death(At one-year since interventions)
- Rate of all-cause death(At one-year since interventions)
- Rate of spontaneous myocardial infarction (SMI)(Within one-year follow-up)
- Rate of clinically-driven revascularization(At one-year since coronary artery intervention)
- Rate of stent thrombosis(At one-year since coronary artery intervention)