Intravascular Imaging-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus: the Muticenter, Randomized, Prospective IVI-DIABETES Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,332
- 试验地点
- 1
- 主要终点
- Rate of target vessel failure (TVF)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Randomization will be performed in the catheter laboratory by an invasive nurse. Staff in the catheter laboratory will be not blinded to the treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Any condition likely to interfere with study processes including medication compliance or follow-up visits (e.g. dementia, alcohol abuse, severe frailty, long distance to travel for follow-up visits, etc.)
研究组 & 干预措施
Intravascular imaging-guided PCI group
For patients in this group, intravascular imaging will be encouraged to performed prior-to and post-coronary intervention using new generation drug-eluting stents
干预措施: Intravascular imaging-guided PCI (Procedure)
Angiography-guided PCI group
For patients in this group, implantation of a new generation drug-eluting stent will be guided by angiography only. Unless coronary artery lesion is complex or ambiguous, intravascular imaging is not allowed to be used. If intravascular imaging is used because of the reason mentioned above, post-stenting assessment is absolutely not allowed.
干预措施: Angiography-guided PCI group (Procedure)
结局指标
主要结局
Rate of target vessel failure (TVF)
时间窗: At one-year since interventions
TVF is defined as a composite of cardiac death, target-vessel myocardial infraction, or clinically driven target vessel revascularization
次要结局
- 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)
研究者
Shaoliang Chen, MD
Professor
Nanjing First Hospital, Nanjing Medical University