한빛사논문
Ki Hong Choi, MD1; Taek Kyu Park, MD, PhD1; Young Bin Song, MD1; Joo Myung Lee, MD1; Jong-Young Lee, MD2; Seung-Jae Lee, MD2; Sang Yeub Lee, MD3,4; Sang Min Kim, MD3; Kyeong Ho Yun, MD5; Jae Young Cho, MD5; Chan Joon Kim, MD6; Hyo-Suk Ahn, MD6; Hyuck-Jun Yoon, MD7; Yong Hwan Park, MD8; Wang Soo Lee, MD9; Jin-Ok Jeong, MD10; Pil-Sang Song, MD10; Joon-Hyung Doh, MD11; Sang-Ho Jo, MD12; Chang-Hwan Yoon, MD13; Min Gyu Kang, MD14; Jin-Sin Koh, MD14; Kwan Yong Lee, MD15; Young-Hyo Lim, MD16; Yun-Hyeong Cho, MD17; Jin-Man Cho, MD18; Woo Jin Jang, MD19; Kook-Jin Chun, MD20; David Hong, MD1; Jeong Hoon Yang, MD1; Seung-Hyuk Choi, MD1; Hyeon-Cheol Gwon, MD1; Joo-Yong Hahn, MD1; Chang-Wook Nam, MD, PhD7; for the RENOVATE COMPLEX-PCI Investigators
1Division of Cardiology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
2Division of Cardiology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea
3Division of Cardiology, Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea
4Division of Cardiology, Department of Internal Medicine, Chung-Ang University College of Medicine, Chung-Ang University Gwangmyeong Hospital, Gwangmyeong, Korea
5Division of Cardiology, Department of Internal Medicine, Wonkwang University Hospital, Iksan, Korea
6Division of Cardiology, Department of Internal Medicine, The Catholic University of Korea, Uijeongbu St. Mary’s Hospital, Seoul, Korea
7Division of Cardiology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, Korea
8Division of Cardiology, Department of Internal Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Korea
9Division of Cardiology, Department of Internal Medicine, Chung-Ang University College of Medicine, Chung-Ang University Hospital, Seoul, Korea
10Division of Cardiology, Department of Internal Medicine, Chungnam National University Hospital, Chungnam National University College of Medicine, Daejeon, Korea
11Division of Cardiology, Department of Internal Medicine, Inje University Ilsan-Paik Hospital, Goyang, Korea
12Division of Cardiology, Department of Internal Medicine, Cardiovascular Center, Hallym University Sacred Heart Hospital, Anyang, Korea
13Division of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea
14Division of Cardiology, Department of Internal Medicine, Gyeongsang National University School of Medicine, Gyeongsang National University Hospital, Jinju, Korea
15Division of Cardiology, Department of Internal Medicine, The Catholic University of Korea, Incheon St Mary’s Hospital, Seoul, Korea
16Division of Cardiology, Department of Internal Medicine, Hanyang University Seoul Hospital, College of Medicine, Hanyang University, Seoul, Korea
17Division of Cardiology, Department of Internal Medicine, Hanyang University Myongji Hospital, Goyang, Korea
18Division of Cardiology, Department of Internal Medicine, Kyung Hee University Hospital at Gangdong, Seoul, Korea
19Division of Cardiology, Department of Internal Medicine, Ewha Womans University College of Medicine, Seoul, Korea
20Division of Cardiology, Department of Internal Medicine, Pusan National University Yangsan Hospital, Yangsan, Korea
Drs K. H. Choi and T. K. Park contributed equally as the first authors.
Corresponding Author: Young Bin Song, MD, PhD; Chang-Wook Nam, MD, PhD
Abstract
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 < .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 < .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.
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