Xiao-Fei Gao1, Zhen Ge1, Xiang-Quan Kong1, Jing Kan1, Leng Han2, Shu Lu3, Nai-Liang Tian1, Song Lin1, Qing-Hua Lu4, Xiao-Yan Wang5, Qi-Hua Li6, Zhi-Zhong Liu1, Yan Chen7, Xue-Song Qian8, Juan Wang2, Da-Yang Chai3, Chong-Hao Chen5, Tao Pan1, Fei Ye1, Jun-Jie Zhang9, Shao-Liang Chen10. 1. Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China. 2. Department of Cardiology, Changshu No. 1 People's Hospital, Changshu, China. 3. Department of Cardiology, The First People's Hospital of Taicang, Taicang, China. 4. Department of Cardiology, The Second Hospital of Shandong University, Jinan, China. 5. Department of Cardiology, Wuxi Third People's Hospital, Wuxi, China. 6. Department of Cardiology, Changzhou Traditional Chinese Medicine Hospital, Changzhou, China. 7. Department of Cardiology, Fuwai Central China Cardiovascular Hospital, Zhengzhou, China. 8. Department of Cardiology, The First People's Hospital of Zhangjiagang, Zhangjiagang, China. 9. Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China. Electronic address: jameszll@163.com. 10. Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China. Electronic address: chmengx@126.com.
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).
RCT Entities:
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).
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