Journal of the American College of Cardiology
Intravascular Ultrasound-Guided Versus Angiography-Guided Implantation of Drug-Eluting Stent in All-Comers: The ULTIMATE trial
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Author + information
- Junjie Zhang, PhD†∗∗ (jameszll{at}163.com),
- Xiaofei Gao, MD†,
- Jing Kan, MBBS†,
- Zhen Ge, MD†,
- Leng Han, MD¶,
- Shu Lu, MD||,
- Nailiang Tian, MD†,
- Song Lin, MD†,
- Qinghua Lu, MD#,
- Xueming Wu, MD∗,
- Qihua Li, MD‡,
- Zhizhong Liu, PhD†,
- Yan Chen, MD§,
- Xuesong Qian, MD£,
- Juan Wang, MD¶,
- Dayang Chai, MD||,
- Chonghao Chen, MD∗,
- Xiaolong Li, MD‡,
- Bill D. Gogas, MD††,
- Tao Pan, MBBS†,
- Shoujie Shan, MD†,
- Fei Ye, MD† and
- Shao-Liang Chen, MD, PhD†∗ (chmengx{at}126.com)
- †Department of cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China
- ¶Department of cardiology, Changshu NO.1 People’s Hospital, Changshu, China
- ||Department of cardiology, The First People’s Hospital of Taicang, Taicang, China
- #Department of cardiology, The Second Hospital of Shandong University, Jinan, China
- ∗Department of cardiology, Wuxi Third People’s Hospital, Wuxi, China
- ‡Department of cardiology, Changzhou Traditional Chinese Medicine Hospital, Changzhou, China
- §Department of cardiology, Fuwai Central China Cardiovascular Hospital, Zhengzhou, China
- £Department of cardiology, The First People’s Hospital of Zhangjiagang, Zhangjiagang, China
- ††Department of cardiology, Emory University Hospital, Atlanta, Georgia
- ↵∗Reprint requests and correspondence to: Shao-Liang Chen, MD, PhD Department of cardiology, Nanjing First Hospital Nanjing Medical University No. 68 Changle road, 210006 Nanjing, China Telephone & Fax: +86-25-52208048
- ↵∗∗Junjie Zhangm, PhD, Department of cardiology Nanjing First Hospital, Nanjing Medical University No. 68 Changle road 210006 Nanjing, China, Telephone & Fax: +86-25-52208048.
Abstract
Background Intravascular ultrasound (IVUS)-guided drug-eluting stent (DES) implantation is associated with less major adverse cardiovascular events (MACE) compared with angiography guidance for patients with individual lesion subset. However, the beneficiary effect on MACE outcome of IVUS guidance over angiography guidance in all-comers who undergo DES implantation still remains understudied.
Objectives This study aimed to determine the benefits of IVUS guidance over angiography guidance during DES implantation in all-comer patients.
Methods A total of 1448 all-comer patients who required DES implantation were randomly assigned (1:1 ratio) to either IVUS guidance or Angiography guidance group. Primary endpoint was target vessel failure (TVF) at 12 months, including cardiac death, target vessel myocardial infarction (TV-MI), and clinically-driven target vessel revascularization (TVR). Procedure was defined as success if IVUS-defined all optimal criteria were met.
Results At 12 months follow-up, 60 (4.2%) TVFs occurred, with 21 (2.9%) in the IVUS group and 39 (5.4%) in the Angiography group (hazard ratio [HR] 0.530, 95% confidence interval [CI] 0.312-0.901; p=0.019). In the IVUS group, TVF was recorded in 1.6% of patients with successful procedures, compared to 4.4% in patients who failed to achieve all optimal criteria (HR: 0.349; 95%CI: 0.135-0.898; p=0.029). The significant reduction of clinically-driven target lesion revascularization (TLR) or definite stent thrombosis (HR: 0.407; 95% CI: 0.188-0.880; p=0.018) based-on lesion level analysis by IVUS guidance was not achieved when patient-level analysis was performed.
Conclusions The present study demonstrated that IVUS-guided DES implantation significantly improved clinical outcome in all-comers, particularly for patients who had an IVUS-defined optimal procedure, compared to angiography guidance.
Footnotes
Disclosure: The authors certify that: (1) the paper is not under consideration elsewhere, (2) no part of the paper has been previously published, (3) all of the authors have read and approved the manuscript, and (4) none of the authors have any relevant disclosures.
Funding: The UNTIMATE trial was granted by the National Natural Science Foundation of China (NSFC 81270191, NSFC 91439118, and NSFC 91639303), and was jointly supported by Six Talent Peaks Project in Jiangsu Province (2014-WSN-058), Nanjing Health and Family Planning Commission (YKK16124), Nanjing Health Youth Talent Training project (QRX17017), and Nanjing Municipal Commission of Science & Technology (201715026).
Tweet: ULTIMATE trial reported that 1-year target vessel failure was 2.9% in the IVUS-guided DES implantation and 5.4% in the Angiography.
Clinical Trial: NCT02215915
- Received August 15, 2018.
- Revision received September 13, 2018.
- Accepted September 13, 2018.
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