作者
Jae Chun Hyun,Joo Myung Lee,Ki Hong Choi,Jong‐Young Lee,Seung‐Jae Lee,Sang Yeub Lee,Sang Min Kim,Kyeong Ho Yun,Jae Young Cho,Chan Joon Kim,Hyo–Suk Ahn,Chang Wook Nam,Hyuck–Jun Yoon,Yong Hwan Park,Jin‐Ok Jeong,Pil Sang Song,Joon–Hyung Doh,Sang Ho,Chang Hwan Yoon,Min Gyu Kang,Jin‐Sin Koh,Kwan Yong Lee,Young‐Hyo Lim,Yun-Hyeong Cho,Jin‐Man Cho,Woo Jin Jang,Kook Jin Chun,David Hong,Taek Kyu Park,Jeong Hoon Yang,Seung‐Hyuk Choi,Hyeon‐Cheol Gwon,Joo‐Yong Hahn,Wang Soo Lee,Young Bin Song,Hyun‐Jong Lee,Dong Ryeol Ryu,Kyu T Park,Kiyuk Chang,Seonwoo Kim,Dong Yeon Kim,Seung-Myeong Shin,Jinshil Kim,Jaeyoung Park,Seung–Hyun Lee,Eun-A Kim,Hyein Kang,Su Jin Hwang,Yeonhui Lee,Hyun Sung Joh,Se Young Im
摘要
There have been heterogeneous results related to sex differences in prognosis after percutaneous coronary artery intervention (PCI) for complex coronary artery lesions.To evaluate potential differences in outcomes with intravascular imaging-guided PCI of complex coronary artery lesions between women and men.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.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.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.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).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.ClinicalTrials.gov Identifier: NCT03381872.