3-Year Outcomes of the ULTIMATE Trial Comparing Intravascular Ultrasound Versus Angiography-Guided Drug-Eluting Stent Implantation
Xiao-Fei Gao, Zhen Ge, Xiang-Quan Kong, Jing Kan, Leng Han, Shu Lu, Nai-Liang Tian, Song Lin, Qing-Hua Lu, Xiao-Yan Wang, Qi-Hua Li, Zhi-Zhong Liu, Yan Chen, Xue-Song Qian, Juan Wang, Da-Yang Chai, Chong-Hao Chen, Tao Pan, Fei Ye, Jun-Jie Zhang, Shao-Liang Chen, ULTIMATE Investigators, Xiao-Fei Gao, Zhen Ge, Xiang-Quan Kong, Jing Kan, Leng Han, Shu Lu, Nai-Liang Tian, Song Lin, Qing-Hua Lu, Xiao-Yan Wang, Qi-Hua Li, Zhi-Zhong Liu, Yan Chen, Xue-Song Qian, Juan Wang, Da-Yang Chai, Chong-Hao Chen, Tao Pan, Fei Ye, Jun-Jie Zhang, Shao-Liang Chen, ULTIMATE Investigators
Abstract
Objectives: The aim of this study was to explore the difference in target vessel failure (TVF) 3 years after intravascular ultrasound (IVUS) guidance versus angiographic guidance among all comers undergoing second-generation drug-eluting stent (DES) implantation.
Background: The multicenter randomized ULTIMATE (Intravascular Ultrasound Guided Drug Eluting Stents Implantation in "All-Comers" Coronary Lesions) trial showed a lower incidence of 1-year TVF after IVUS-guided DES implantation among all comers compared with angiographic guidance. However, the 3-year clinical outcomes of the ULTIMATE trial remain unknown.
Methods: A total of 1,448 all comers undergoing DES implantation who were randomly assigned to either IVUS guidance or angiographic guidance in the ULTIMATE trial were followed for 3 years. The primary endpoint was the risk for TVF at 3 years. The safety endpoint was definite or probable stent thrombosis (ST).
Results: At 3 years, TVF occurred in 47 patients (6.6%) in the IVUS-guided group and in 76 patients (10.7%) in the angiography-guided group (p = 0.01), driven mainly by the decrease in clinically driven target vessel revascularization (4.5% vs. 6.9%; p = 0.05). The rate of definite or probable ST was 0.1% in the IVUS-guided group and 1.1% in the angiography-guided group (p = 0.02). Notably, the IVUS-defined optimal procedure was associated with a significant reduction in 3-year TVF relative to that with the suboptimal procedure.
Conclusions: IVUS-guided DES implantation was associated with significantly lower rates of TVF and ST during 3-year follow-up among all comers, particularly those who underwent the IVUS-defined optimal procedure compared with those with angiographic guidance. (Intravascular Ultrasound Guided Drug Eluting Stents Implantation in "All-Comers" Coronary Lesions; NCT02215915).
Keywords: all-comers; drug-eluting stent; intravascular ultrasound; target vessel failure.
Conflict of interest statement
Funding Support and author Disclosures This study was funded by the National Natural Science Foundation of China (NSFC 81970307) and was jointly supported by the Six Talent Peaks Project of Jiangsu Province (2019-WSN-156), the Social Development Project of Jiangsu Province (BE2019616), the Jiangsu Commission of Health (H2019077), the Jiangsu Provincial Special Program of Medical Science (BE2019615), the Nanjing Commission of Health (ZKX19027), and the Nanjing Health Youth Talent Training project (QRX17017). The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.
Source: PubMed