Intravascular Imaging and Angiography Guidance in Diabetic Patients Undergoing Complex PCI: A Pre-Specified Subgroup Analysis of a Randomized Clinical Trial

Background: Data regarding the differential effects of intravascular imaging guidance during complex percutaneous coronary intervention (PCI) based on the presence of diabetes mellitus (DM) are limited. Methods: This pre-specified sub-study analyzed the impact of intravascular imaging on outcomes in patients with or without DM undergoing complex PCI, using data from the RENOVATE-COMPLEX-PCI. The trial enrolled 1,639 patients who underwent complex PCI and were randomly assigned to undergo intravascular imaging or angiography guidance at a 2:1 ratio. The primary endpoint was a target vessel failure (TVF, a composite of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization). The RENOVATE-COMPLEX-PCI is registered with ClinicalTrials.gov, NCT03381872. Findings: Among the total population, 617 patients (37·6%) had DM. At a median follow-up of 2.1 years (interquartile range 1·4-3·0), the incidence of TVF was significantly higher in patients with DM compared to those without DM. Among patients without DM, the intravascular imaging-guided PCI group had a significantly lower incidence of TVF compared with the angiography-guided PCI group (4·7% vs. 12·2%, hazard ratio [HR]:0·41, 95% confidence interval [CI]:0·25-0·67, p<0.001). Conversely, in patients with DM, the risk of TVF was not significantly different between the two groups (12·9% vs. 12·3%, HR:0·97, 95%CI:0·60-1·57, p=0·90). There was a significant interaction between the use of intravascular imaging and DM for the risk of TVF (interaction-p=0·02). Among diabetic patients, only those with good glycemic control (hemoglobin A1c ≤7·5%) and who achieved stent optimization by intravascular imaging were associated with lower risk of future ischemic events. Interpretation: For PCI of the complex coronary lesion, intravascular imaging guidance reduced the risk of TVF compared to angiography guidance in non-diabetic patients but not in diabetic patients. In patients with DM undergoing complex PCI, attention should be paid to stent optimization using intravascular imaging as well as glycemic control for improving prognosis. Trial Registration: ClinicalTrials.gov Identifier: NCT03381872. Funding: Abbott Vascular and Boston Scientific. Declaration of Interest: Prof. Joo-Yong Hahn received an Institutional Research Grant from National Evidence-based Healthcare Collaborating Agency, Ministry of Health & Welfare, Korea, Abbott Vascular, Biosensors, Boston Scientific, Daiichi Sankyo, Donga-ST, and Medtronic Inc. Dr. Joo Myung Lee received an Institutional Research Grant from Abbott Vascular, Boston Scientific, Philips Volcano, Terumo Corporation, Zoll Medical, and Donga-ST. Prof. Hyeon-Cheol Gwon received an Institutional Research Grant from Abbott Vascular, Boston Scientific, and Medtronic Inc. All other authors declare that there are no competing interests to declare. Ethical Approval: All patients provided written informed consent before randomization and the study protocol was approved by the institutional review board at each participating center. An independent data and safety monitoring board monitored the trial and an independent clinical- event adjudication committee whose members were masked to the study group assignments assessed all clinical outcomes.