IVI-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus

Официальное название

Intravascular Imaging-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus: the Muticenter, Randomized, Prospective IVI-DIABETES Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Intravascular imaging-guided PCI
  Intravascular imaging including intravascular ultrasound or optical coherence tomography.
• Процедура Angiography-guided PCI group
  Deployment of a drug-eluting stent under angiography.

Первичные конечные точки

• Rate of target vessel failure (TVF) [Срок оценки: At one-year since interventions]

Вторичные конечные точки (7)

• Rate of target vessel failure without procedure-related MI [Срок оценки: At one-year since interventions]
• Rate of cardiac death [Срок оценки: At one-year since interventions]
• Rate of all-cause death [Срок оценки: At one-year since interventions]
• Rate of procedure-related myocardial infarction (PMI) [Срок оценки: Within 48 h since coronary intervention]
• Rate of spontaneous myocardial infarction (SMI) [Срок оценки: Within one-year follow-up]
• Rate of clinically-driven revascularization [Срок оценки: At one-year since coronary artery intervention]
• Rate of stent thrombosis [Срок оценки: At one-year since coronary artery intervention]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Nanjing First Hospital — Нанкин

Публикации

• Gao XF, Kan J, Wu HY, Chen J, Chen X, Wen SY, Gong YT, Tong Q, Luo J, Shao YB, Gill BUA, Malik FTN, Santoso T, Daggubati R, Rodriguez AE, Francesco L, Rahman A, Sheiban I, Kedev S, Munawar M, Kwan TW, Wang Y, Ye F, Zhang JJ, Shou XL, Chen SL; IVI-DIABETES investigators. Intravascular imaging-guided versus angiography-guided percutaneous coronary intervention in patients with diabetes mellitus: Rat PMID 39914556

Идентификаторы

NCT: NCT06380868 · Nanjing-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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