• N. Engl. J. Med. · May 2023

    Randomized Controlled Trial Multicenter Study Comparative Study

    Intravascular Imaging-Guided or Angiography-Guided Complex PCI.

    • Joo Myung Lee, Ki Hong Choi, Young Bin Song, 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, Wang Soo Lee, Jin-Ok Jeong, Pil Sang Song, Joon-Hyung Doh, Sang-Ho Jo, 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, and RENOVATE-COMPLEX-PCI Investigators.
    • From Samsung Medical Center (J.M.L., K.H.C., Y.B.S., D.H., T.K.P., J.H.Y., S.-H.C., H.-C.G., J.-Y.H.) and Kangbuk Samsung Hospital (J.-Y.L., S.-J.L.), Sungkyunkwan University School of Medicine, the Catholic University of Korea, Uijeongbu St. Mary's Hospital (C.J.K., H.-S.A.), Chung-Ang University College of Medicine, Chung-Ang University Hospital (W.S.L.), the Catholic University of Korea, Incheon St. Mary's Hospital (K.Y.L.), Hanyang University Seoul Hospital, College of Medicine, Hanyang University (Y.-H.L.), Kyung Hee University Hospital at Gangdong (J.-M.C.), and Ewha Womans University College of Medicine (W.J.J.), Seoul, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju (S.Y.L., S.M.K.), Chung-Ang University College of Medicine, Chung-Ang University Gwangmyeong Hospital, Gwangmyeong (S.Y.L.), Wonkwang University Hospital, Iksan (K.H.Y., J.Y.C.), Keimyung University Dongsan Hospital, Daegu (C.-W.N., H.-J.Y.), Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon (Y.H.P.), Chungnam National University Hospital, Chungnam National University College of Medicine, Daejeon (J.-O.J., P.S.S.), Inje University Ilsan-Paik hospital, Goyang (J.-H.D.), the Cardiovascular Center, Hallym University Sacred Heart Hospital, Anyang (S.-H.J.), Seoul National University Bundang Hospital, Seongnam-si (C.-H.Y.), Gyeongsang National University School of Medicine, Gyeongsang National University Hospital, Jinju (M.G.K., J.-S.K.), Hanyang University Myongji Hospital, Goyang (Y.-H.C.), and Pusan National University Yangsan Hospital, Yangsan (K.-J.C.) - all in South Korea.
    • N. Engl. J. Med. 2023 May 4; 388 (18): 166816791668-1679.

    BackgroundData regarding clinical outcomes after intravascular imaging-guided percutaneous coronary intervention (PCI) for complex coronary-artery lesions, as compared with outcomes after angiography-guided PCI, are limited.MethodsIn this prospective, multicenter, open-label trial in South Korea, we randomly assigned patients with complex coronary-artery lesions in a 2:1 ratio to undergo either intravascular imaging-guided PCI or angiography-guided PCI. In the intravascular imaging group, the choice between intravascular ultrasonography and optical coherence tomography was at the operators' discretion. The primary end point was a composite of death from cardiac causes, target-vessel-related myocardial infarction, or clinically driven target-vessel revascularization. Safety was also assessed.ResultsA total of 1639 patients underwent randomization, with 1092 assigned to undergo intravascular imaging-guided PCI and 547 assigned to undergo angiography-guided PCI. At a median follow-up of 2.1 years (interquartile range, 1.4 to 3.0), a primary end-point event had occurred in 76 patients (cumulative incidence, 7.7%) in the intravascular imaging group and in 60 patients (cumulative incidence, 12.3%) in the angiography group (hazard ratio, 0.64; 95% confidence interval, 0.45 to 0.89; P = 0.008). Death from cardiac causes occurred in 16 patients (cumulative incidence, 1.7%) in the intravascular imaging group and in 17 patients (cumulative incidence, 3.8%) in the angiography group; target-vessel-related myocardial infarction occurred in 38 (cumulative incidence, 3.7%) and 30 (cumulative incidence, 5.6%), respectively; and clinically driven target-vessel revascularization in 32 (cumulative incidence, 3.4%) and 25 (cumulative incidence, 5.5%), respectively. There were no apparent between-group differences in the incidence of procedure-related safety events.ConclusionsAmong patients with complex coronary-artery lesions, intravascular imaging-guided PCI led to a lower risk of a composite of death from cardiac causes, target-vessel-related myocardial infarction, or clinically driven target-vessel revascularization than angiography-guided PCI. (Supported by Abbott Vascular and Boston Scientific; RENOVATE-COMPLEX-PCI ClinicalTrials.gov number, NCT03381872).Copyright © 2023 Massachusetts Medical Society.

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