한빛사논문
Ji Hyun Cha 1, Joo Myung Lee 1, Ki Hong Choi 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, Chang-Wook Nam 7, Hyuck-Jun Yoon 7, Yong Hwan Park 8, Jin-Ok Jeong 9, Pil Sang Song 9, Joon-Hyung Doh 10, Sang-Ho Jo 11, Chang-Hwan Yoon 12, Min Gyu Kang 13, Jin-Sin Koh 13, Kwan Yong Lee 14, Young-Hyo Lim 15, Yun-Hyeong Cho 16, Jin-Man Cho 17, Woo Jin Jang 18, Kook-Jin Chun 19, David Hong 1, Taek Kyu Park 1, Jeong Hoon Yang 1, Seung-Hyuk Choi 1, Hyeon-Cheol Gwon 1, Joo-Yong Hahn 1, Wang Soo Lee 20, Young Bin Song 1; RENOVATE-COMPLEX-PCI Investigators
1Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
2Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
3Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea.
4Chung-Ang University College of Medicine, Chung-Ang University Gwangmyeong Hospital, Gwangmyeong, Korea.
5Wonkwang University Hospital, Iksan, Korea.
6The Catholic University of Korea, Uijeongbu St. Mary's Hospital, Seoul, Korea.
7Keimyung University Dongsan Hospital, Daegu, Korea.
8Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Korea.
9Chungnam National University Hospital, Chungnam National University College of Medicine, Daejeon, Korea.
10Inje University Ilsan Paik Hospital, Goyang, Korea.
11Cardiovascular Center, Hallym University Sacred Heart Hospital, Anyang, Korea.
12Seoul National University Bundang Hospital, Seongnam, Korea.
13Gyeongsang National University School of Medicine, Gyeongsang National University Hospital, Jinju, Korea.
14The Catholic University of Korea, Incheon St Mary's Hospital, Seoul, Korea.
15Hanyang University Seoul Hospital, College of Medicine, Hanyang University, Seoul, Korea.
16Hanyang University Myongji Hospital, Goyang, Korea.
17Kyung Hee University Hospital at Gangdong, Seoul, Korea.
18Ewha Womans University College of Medicine, Seoul, Korea.
19Pusan National University Yangsan Hospital, Yangsan, Korea.
20Chung-Ang University College of Medicine, Chung-Ang University Hospital, Seoul, Korea.
Drs Cha and Joo Myung Lee contributed equally as co–first authors.
Drs W. Lee and Y. Song equally contributed as co–corresponding authors.
Corresponding Authors: Wang Soo Lee, MD, PhD, Young Bin Song, MD, PhD,
Abstract
Importance: There have been heterogeneous results related to sex differences in prognosis after percutaneous coronary artery intervention (PCI) for complex coronary artery lesions.
Objective: To evaluate potential differences in outcomes with intravascular imaging-guided PCI of complex coronary artery lesions between women and men.
Design, setting, and participants: This prespecified substudy evaluates the interaction of sex in the investigator-initiated, open-label, multicenter RENOVATE-COMPLEX-PCI randomized clinical trial, which demonstrated the superiority of intravascular imaging-guided PCI compared with angiography-guided PCI in patients with complex coronary artery lesions. The trial was conducted at 20 sites in Korea. Patients with complex coronary artery lesions undergoing PCI were enrolled between May 2018 and May 2021, and the median (IQR) follow-up period was 2.1 (1.4-3.0) years. Data were analyzed from December 2022 to December 2023.
Interventions: After diagnostic coronary angiography, eligible patients were randomly assigned in a 2:1 ratio to receive intravascular imaging-guided PCI or angiography-guided PCI. The choice and timing of the intravascular imaging device were left to the operators' discretion.
Main outcomes and measures: The primary end point was target vessel failure, defined as a composite of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization. Secondary end points included individual components of the primary end point.
Results: Of 1639 included patients, 339 (20.7%) were women, and the mean (SD) age was 65.6 (10.2) years. There was no difference in the risk of the primary end point between women and men (9.4% vs 8.3%; adjusted hazard ratio [HR], 1.39; 95% CI, 0.89-2.18; P = .15). Intravascular imaging-guided PCI tended to have lower incidence of the primary end point than angiography-guided PCI in both women (5.2% vs 14.5%; adjusted HR, 0.34; 95% CI, 0.15-0.78; P = .01) and men (8.3% vs 11.7%; adjusted HR, 0.72; 95% CI, 0.49-1.05; P = .09) without significant interaction (P for interaction = .86).
Conclusions and relevance: In patients undergoing complex PCI, compared with angiographic guidance, intravascular imaging guidance was associated with similar reduction in the risk of target vessel failure among women and men. The treatment benefit of intravascular imaging-guided PCI showed no significant interaction between treatment strategy and sex.
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