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Sang Yoon Lee MD a,∗, Ki Hong Choi MD, PhD a,∗, Chan Joon Kim MD, PhD b, Joo Myung Lee MD, MPH, PhD a, Young Bin Song MD, PhD a, Jong-Young Lee MD, PhD c, Seung-Jae Lee MD, PhD c, Sang Yeub Lee MD, PhD d,e, Sang Min Kim MD, PhD d, Kyeong Ho Yun MD, PhD f, Jae Young Cho MD, PhD g, Hyo-Suk Ahn MD, PhD b, Chang-Wook Nam MD, PhD g, Hyuck-Jun Yoon MD, PhD g, Yong Hwan Park MD, PhD h, Wang Soo Lee MD, PhD i, Jin-Ok Jeong MD, PhD j, Pil Sang Song MD, PhD j, Sung Eun Kim MD k, Joon-Hyung Doh MD, PhD k, Sang-Ho Jo MD, PhD l, Chang-Hwan Yoon MD, PhD m, Min Gyu Kang MD, PhD n, Jin-Sin Koh MD, PhD n, Kwan Yong Lee MD, PhD o, Young-Hyo Lim MD, PhD p, Yun-Hyeong Cho MD, PhD q, Jin-Man Cho MD, PhD r, Woo Jin Jang MD, PhD s, Kook-Jin Chun MD, PhD t, David Hong MD a, Taek Kyu Park MD, PhD a, Jeong Hoon Yang MD, PhD a, Seung-Hyuk Choi MD, PhD a, Hyeon-Cheol Gwon MD, PhD a, Joo-Yong Hahn MD, PhD a the RENOVATE-COMPLEX-PCI Investigators
aSamsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
bThe Catholic University of Korea, Uijeongbu St. Mary’s Hospital, Seoul, Korea
cKangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea
dChungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea
eChung-Ang University College of Medicine, Chung-Ang University Gwangmyeong Hospital, Gwangmyeong, Korea
fWonkwang University Hospital, Iksan, Korea
gKeimyung University Dongsan Hospital, Daegu, Korea
hSamsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Korea
iChung-Ang University College of Medicine, Chung-Ang University Hospital, Seoul, Korea
jChungnam National University Hospital, Chungnam National University College of Medicine, Daejeon, Korea
kInje University Ilsan Paik Hospital, Goyang, Korea
lCardiovascular Center, Hallym University Sacred Heart Hospital, Anyang, Korea
mSeoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea
nGyeongsang National University School of Medicine, Gyeongsang National University Hospital, Jinju, Korea
oThe Catholic University of Korea, Incheon St. Mary’s Hospital, Seoul, Korea
pHanyang University Seoul Hospital, College of Medicine, Hanyang University, Seoul, Korea
qHanyang University Myongji Hospital, Goyang, Korea
rKyung Hee University Hospital at Gangdong, Seoul, Korea
sEwha Womans University College of Medicine, Seoul, Korea
tPusan National University Yangsan Hospital, Yangsan, Korea
Address for correspondence: Dr Chan Joon Kim, Joo-Yong Hahn
∗Drs Lee and Choi are co-first authors.
Abstract
Background: It is unclear whether the beneficial effects of intravascular imaging-guided stent optimization vary by clinical presentation during complex percutaneous coronary intervention (PCI).
Objectives: In this prespecified, stratified subgroup analysis from RENOVATE-COMPLEX-PCI (Randomized Controlled Trial of Intravascular Imaging Guidance versus Angiography-Guidance on Clinical Outcomes After Complex PCI), we sought to compare the outcomes between intravascular imaging vs angiography guidance according to clinical presentation.
Methods: Patients with complex coronary artery lesions were randomly assigned to undergo either intravascular imaging-guided PCI or angiography-guided PCI in a 2:1 ratio. The primary endpoint was target vessel failure (TVF), which is a composite of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization.
Results: Of 1,639 patients, 832 (50.8%) presented with acute coronary syndrome (ACS) and 807 (49.2%) with chronic coronary syndrome. During a median follow-up of 2.1 years (Q1-Q3: 1.4-3.0 years), there was no significant interaction between the treatment effect of intravascular imaging and clinical presentation (P for interaction = 0.19). Among patients with ACS, the incidences of TVF were 10.4% in the intravascular imaging group and 14.6% in the angiography group (HR: 0.74; 95% CI: 0.48-1.15; P = 0.18). Among patients with CCS, the incidences of TVF were 5.0% in the intravascular imaging group and 10.4% in the angiography group (HR: 0.46; 95% CI: 0.27-0.80; P = 0.006). Achieving stent optimization by intravascular imaging resulted in a reduced risk of TVF among patients with ACS who were randomly assigned to intravascular imaging-guided PCI for complex coronary lesions (optimized vs unoptimized, 6.5% vs 14.1%; HR: 0.49; 95% CI: 0.27-0.87; P = 0.02) but not those with CCS (5.4% vs 4.7%, HR: 1.18; 95% CI: 0.53-2.59; P = 0.69).
Conclusions: No significant interaction was observed between the benefits of intravascular imaging and clinical presentation in the risk of TVF. Stent optimization by intravascular imaging was particularly important for ACS patients. (Intravascular Imaging- Versus Angiography-Guided Percutaneous Coronary Intervention For Complex Coronary Artery Disease [RENOVATE]; NCT03381872).
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