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Randomized Controlled Trial
. 2024 Jun 3;7(6):e2417613.
doi: 10.1001/jamanetworkopen.2024.17613.

Intravascular Imaging and Angiography Guidance in Complex Percutaneous Coronary Intervention Among Patients With Diabetes: A Secondary Analysis of a Randomized Clinical Trial

Ki Hong Choi  1 , Taek Kyu Park  1 , Young Bin Song  1 , Joo Myung Lee  1 , Jong-Young Lee  2 , Seung-Jae Lee  2 , Sang Yeub Lee  3   4 , Sang Min Kim  3 , Kyeong Ho Yun  5 , Jae Young Cho  5 , Chan Joon Kim  6 , Hyo-Suk Ahn  6 , Hyuck-Jun Yoon  7 , Yong Hwan Park  8 , Wang Soo Lee  9 , Jin-Ok Jeong  10 , Pil-Sang Song  10 , Joon-Hyung Doh  11 , Sang-Ho Jo  12 , Chang-Hwan Yoon  13 , Min Gyu Kang  14 , Jin-Sin Koh  14 , Kwan Yong Lee  15 , Young-Hyo Lim  16 , Yun-Hyeong Cho  17 , Jin-Man Cho  18 , Woo Jin Jang  19 , Kook-Jin Chun  20 , David Hong  1 , Jeong Hoon Yang  1 , Seung-Hyuk Choi  1 , Hyeon-Cheol Gwon  1 , Joo-Yong Hahn  1 , Chang-Wook Nam  7 ; RENOVATE COMPLEX-PCI Investigators
Collaborators, Affiliations
Randomized Controlled Trial

Intravascular Imaging and Angiography Guidance in Complex Percutaneous Coronary Intervention Among Patients With Diabetes: A Secondary Analysis of a Randomized Clinical Trial

Ki Hong Choi et al. JAMA Netw Open. .

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.

Trial registration: ClinicalTrials.gov Identifier: NCT03381872.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Hahn reported receiving grants from Abbott Vascular and Boston Scientific during the conduct of the study and grants from National Evidence-based Healthcare Collaborating Agency, the Ministry of Health & Welfare, Korea; Biosensors; Biotronik; Daiichi Sankyo; Donga-ST; Hanmi Pharmaceutical; and Medtronic outside the submitted work. Dr Nam reported receiving grants from Abbott outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Cumulative Incidences of Target Vessel Failure (TVF) Between Angiography-Guided vs Imaging-Guided Percutaneous Coronary Intervention (PCI) by Diabetes Status
There was a significant interaction between presence of diabetes and use of intravascular imaging for the risk of TVF (P for interaction = .02). HR indicates hazard ratio.
Figure 2.
Figure 2.. Comparative Hazard Ratios (HRs) of Target Vessel Failure by Glycemic Control Status and Imaging-Guided Stent Optimization for Patients With Diabetes Who Underwent Complex Percutaneous Coronary Intervention
Error bars represent 95% CIs. Squares represent HRs. NA indicates not available.
See this image and copyright information in PMC

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