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Intravascular ultrasound-guided versus angiography-guided percutaneous coronary intervention in acute coronary syndromes (IVUS-ACS): a two-stage, multicentre, randomised trial

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单位： [1]Nanjing First Hospital, Nanjing Medical University, Nanjing, China [2]Punjab Institute of Cardiology, Lahore, Pakistan [3]Gansu Provincial People’s Hospital, Lanzhou, China [4]Xiamen Heart Center, Xiamen University, Xiamen, China [5]Rawalpindi Institute of Cardiology, Rawalpindi, Pakistan [6]Tongji Hospital, Huazhong University of Science and Technology, Wuhan, China [7]National Institute of Cardiovascular Diseases of Pakistan, Karachi, Pakistan [8]People’s Hospital of Wuhan University, Wuhan, China [9]Pervez Ilahi Institute of Cardiology, Lahore, Pakistan [10]The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, China [11]Pederzoli Hospital, Peschiera del Garda, Verona, Italy [12]Airdale General Hospital of the United Kingdom, West Yorkshire, UK [13]Center for Public Health and Epidemic Preparedness & Response, Peking University, Beijing, China [14]School of Public Health, Nanjing Medical University,Nanjing, China [15]Cardiovascular Research Foundation at New York, New York, NY, USA [16]The Zena and Michael A Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA

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Intravascular ultrasound-guided percutaneous coronary intervention has been shown to result in superior clinical outcomes compared with angiography-guided percutaneous coronary intervention. However, insufficient data are available concerning the advantages of intravascular ultrasound guidance for patients with an acute coronary syndrome. This trial aimed to investigate whether the use of intravascular ultrasound guidance, as compared with angiography guidance, improves the outcomes of percutaneous coronary intervention with contemporary drug-eluting stents in patients presenting with an acute coronary syndrome.In this two-stage, multicentre, randomised trial, patients aged 18 years or older and presenting with an acute coronary syndrome at 58 centres in China, Italy, Pakistan, and the UK were randomly assigned to intravascular ultrasound-guided percutaneous coronary intervention or angiography-guided percutaneous coronary intervention. Patients, follow-up health-care providers, and assessors were masked to random assignment; however, staff in the catheterisation laboratory were not. The primary endpoint was target vessel failure, a composite of cardiac death, target vessel myocardial infarction, or clinically driven target vessel revascularisation at 1 year after randomisation. This trial is registered at ClinicalTrials.gov, NCT03971500, and is completed.Between Aug 20, 2019 and Oct 27, 2022, 3505 patients with an acute coronary syndrome were randomly assigned to intravascular ultrasound-guided percutaneous coronary intervention (n=1753) or angiography-guided percutaneous coronary intervention (n=1752). 1-year follow-up was completed in 3504 (>99·9%) patients. The primary endpoint occurred in 70 patients in the intravascular ultrasound group and 128 patients in the angiography group (Kaplan-Meier rate 4·0% vs 7·3%; hazard ratio 0·55 [95% CI 0·41-0·74]; p=0·0001), driven by reductions in target vessel myocardial infarction or target vessel revascularisation. There were no significant differences in all-cause death or stent thrombosis between groups. Safety endpoints were also similar in the two groups.In patients with an acute coronary syndrome, intravascular ultrasound-guided implantation of contemporary drug-eluting stents resulted in a lower 1-year rate of the composite outcome of cardiac death, target vessel myocardial infarction, or clinically driven revascularisation compared with angiography guidance alone.The Chinese Society of Cardiology, the National Natural Scientific Foundation of China, and Jiangsu Provincial & Nanjing Municipal Clinical Trial Project.For the Mandarin translation of the abstract see Supplementary Materials section.Copyright © 2024 Elsevier Ltd. All rights reserved.

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大类 | 1 区

医学

小类 | 1 区医学：内科

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大类 | 1 区

医学

小类 | 1 区医学：内科

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第一作者单位： [1]Nanjing First Hospital, Nanjing Medical University, Nanjing, China

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通讯机构： [1]Nanjing First Hospital, Nanjing Medical University, Nanjing, China [16]The Zena and Michael A Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA [*1]Nanjing First Hospital, Nanjing Medical University, Nanjing 210006, China [*2]The Zena and Michael A Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA

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