Intravascular Imaging–Guided Optimization of Complex Percutaneous Coronary Intervention by Sex
Authors: Cha Ji Hyun , Lee Joo Myung , Choi Ki Hong , Lee Jong-Young , Lee Seung-Jae , Lee Sang Yeub , Kim Sang Min , Yun Kyeong Ho , Cho Jae Young , Kim Chan Joon , Ahn Hyo-Suk , Nam Chang-Wook , Yoon Hyuck-Jun , Park Yong Hwan , 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 , Park Taek Kyu , Yang Jeong Hoon , Choi Seung-Hyuk , Gwon Hyeon-Cheol , Hahn Joo-Yong , Lee Wang Soo , Song Young Bin ,   RENOVATE-COMPLEX-PCI Investigators, Lee Hyun-Jong , Ryu Dong R , Park Kyu T , Chang Kiyuk , Kim Seonwoo , Kim Dong-Yeon , Shin Suyoun , Kim Jinshil , Park Jaeyoung , Lee Seunghyun , Kim Euna , Kang Hyein , Hwang Su J , Lee Yeonhui , Joh Hyun S , Im Se Y 
Published: April 2024

ImportanceThere have been heterogeneous results related to sex differences in prognosis after percutaneous coronary artery intervention (PCI) for complex coronary artery lesions.ObjectiveTo evaluate potential differences in outcomes with intravascular imaging–guided PCI of complex coronary artery lesions between women and men.Design, Setting, and ParticipantsThis 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.InterventionsAfter 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 MeasuresThe 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.ResultsOf 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 RelevanceIn 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.Trial RegistrationClinicalTrials.gov Identifier: NCT03381872