Intravascular Imaging and Angiography Guidance in Complex Percutaneous Coronary Intervention Among Patients With Diabetes
Authors: Choi Ki Hong , Park Taek Kyu , Song Young Bin , Lee Joo Myung , Lee Jong-Young , Lee Seung-Jae , Lee Sang Yeub , Kim Sang Min , Yun Kyeong Ho , Cho Jae Young , Kim Chan Joon , Ahn Hyo-Suk , Yoon Hyuck-Jun , Park Yong Hwan , Lee Wang Soo , Jeong Jin-Ok , Song Pil-Sang , Doh Joon-Hyung , Jo Sang-Ho , Yoon Chang-Hwan , Kang Min Gyu , Koh Jin-Sin , Lee Kwan Yong , Lim Young-Hyo , Cho Yun-Hyeong , Cho Jin-Man , Jang Woo Jin , Chun Kook-Jin , Hong David , Yang Jeong Hoon , Choi Seung-Hyuk , Gwon Hyeon-Cheol , Hahn Joo-Yong , Nam Chang-Wook ,   RENOVATE COMPLEX-PCI Investigators, Lee Hyun-Jong , Ryu Dong Ryul , Park Kyu Tae , Chang Kiyuk , Kim Seonwoo , Kim Dong-Yeon , Shin Suyoun , Kim Jinshil , Park Jaeyoung , Lee Seunghyun , Kim Euna , Kang Hyein , Hwang Su Jin , Lee Yeonhui , Joh Hyun Seung , Im Se Young 
Published: June 2024

Importance

Data are limited regarding the effects of intravascular imaging guidance during complex percutaneous coronary intervention (PCI) in patients with diabetes.

Objective

To compare the clinical outcomes of intravascular imaging–guided vs angiography-guided complex PCI in patients with or without diabetes.

Design, Setting, and Participants

This prespecified secondary analysis of a subgroup of patients in RENOVATE-COMPLEX-PCI (Randomized Controlled Trial of Intravascular Imaging Guidance Versus Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention), an investigator-initiated, open-label multicenter trial, analyzed enrolled patients who underwent complex PCI at 20 sites in Korea from May 2018 through May 2021. Eligible patients were randomly assigned in a 2:1 ratio to undergo either the intravascular imaging–guided PCI or angiography-guided PCI. Data analyses were performed from June 2023 to April 2024.

Interventions

Percutaneous coronary intervention was performed either under the guidance of intravascular imaging or angiography alone.

Main Outcomes and Measures

The primary end point was target vessel failure (TVF), defined as a composite of cardiac death, target vessel–related myocardial infarction, or target vessel revascularization.

Results

Among the 1639 patients included in the analysis (mean [SD] age, 65.6 [10.2] years; 1300 males [79.3%]), 617 (37.6%) had diabetes. The incidence of TVF was significantly higher in patients with diabetes than patients without diabetes (hazard ratio [HR], 1.86; 95% CI, 1.33-2.60; P &amp;lt; .001). Among patients without diabetes, 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%; HR, 0.41 [95% CI, 0.25-0.67]; P &amp;lt; .001). Conversely, in patients with diabetes, the risk of TVF was not significantly different between the 2 groups (12.9% vs 12.3%; HR, 0.97 [95% CI, 0.60-1.57]; P = .90). There was a significant interaction between the use of intravascular imaging and diabetes for the risk of TVF (P for interaction = .02). Among patients with diabetes, only those with good glycemic control (hemoglobin A1c level ≤7.5%) and who achieved stent optimization by intravascular imaging showed a lower risk of future ischemic events (HR, 0.31; 95% CI, 0.12-0.82; P = .02).

Conclusions and Relevance

In this secondary analysis of a subgroup of patients in the RENOVATE-COMPLEX-PCI trial, intravascular imaging guidance reduced the risk of TVF compared with angiography guidance in patients without diabetes (but not in patients with diabetes) during complex PCI. In patients with diabetes undergoing complex PCI, attention should be paid to stent optimization using intravascular imaging and glycemic control to improve outcomes.

Trial Registration

ClinicalTrials.gov Identifier: NCT03381872