Effect of Intensified Multifactorial Treatments on Coronary Atherosclerosis in Patients With Coronary Artery Disease and Type 2 Diabetes Mellitus　― Rationale and Design of the Randomized IMPACT-DM Trial ―

Abstract

Background: The effect of Intensified Multifactorial treatments on coronary atherosclerosis in PAtients with Coronary artery disease and Type 2 Diabetes Mellitus (IMPACT-DM) trial was designed to investigate the effects of intensified multifactorial treatments (IMT) on coronary plaque progression in patients with coronary artery disease (CAD) and diabetes.

Methods and Results: In this prospective, randomized, open-label, parallel assignment, multicenter study, eligible patients with diabetes who underwent successful percutaneous coronary intervention in culprit lesions are randomly assigned to receive either IMT or guideline-oriented standard treatments (Control) for 18 months. The IMT are managed according to strict target goals and step-by-step medical treatment protocols based on modern medical treatments. Target goals in IMT and Control groups are set to hemoglobin A1c <6.2% vs. <7.0%; low-density lipoprotein cholesterol <55 mg/dL for any type of CAD vs. <70 mg/dL for acute coronary syndrome, or <100 mg/dL for stable CAD; and blood pressure <120/80 mmHg vs. <130/80 mmHg, respectively. Non-culprit lesions are evaluated using intravascular ultrasound (IVUS) at post-procedure and 18 months follow up. The primary endpoint is absolute changes in percent plaque volumes in non-culprit lesions as assessed using IVUS from post-procedure to 18 months.

Conclusions: The IMPACT-DM trial will clarify the clinical benefits of IMT on non-culprit coronary plaques in patients with diabetes undergoing successful PCI in culprit lesions.