Author + information
- Received August 15, 2018
- Revision received September 13, 2018
- Accepted September 13, 2018
- Published online December 10, 2018.
- Junjie Zhang, MD, PhDa,∗∗∗ (, )
- Xiaofei Gao, MDa,∗,
- Jing Kan, MBBSa,∗,
- Zhen Ge, MDa,
- Leng Han, MDb,
- Shu Lu, MDc,
- Nailiang Tian, MDa,
- Song Lin, MDa,
- Qinghua Lu, MDd,
- Xueming Wu, MDe,
- Qihua Li, MDf,
- Zhizhong Liu, PhDa,
- Yan Chen, MDg,
- Xuesong Qian, MDh,
- Juan Wang, MDb,
- Dayang Chai, MDc,
- Chonghao Chen, MDe,
- Xiaolong Li, MDf,
- Bill D. Gogas, MDi,
- Tao Pan, MBBSa,
- Shoujie Shan, MDa,
- Fei Ye, MDa and
- Shao-Liang Chen, MD, PhDa,∗ ()
- aDepartment of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China
- bDepartment of Cardiology, Changshu NO.1 People’s Hospital, Changshu, China
- cDepartment of Cardiology, The First People’s Hospital of Taicang, Taicang, China
- dDepartment of Cardiology, The Second Hospital of Shandong University, Jinan, China
- eDepartment of Cardiology, Wuxi Third People’s Hospital, Wuxi, China
- fDepartment of Cardiology, Changzhou Traditional Chinese Medicine Hospital, Changzhou, China
- gDepartment of Cardiology, Fuwai Central China Cardiovascular Hospital, Zhengzhou, China
- hDepartment of Cardiology, The First People’s Hospital of Zhangjiagang, Zhangjiagang, China
- iDepartment of Cardiology, Emory University Hospital, Atlanta, Georgia
- ↵∗Address for correspondence:
Dr. Shao-Liang Chen, Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, No. 68 Changle Road, 210006 Nanjing, China.
- ↵∗∗Dr. Junjie Zhang, Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, No. 68 Changle Road, 210006 Nanjing, China.
Background Intravascular ultrasound (IVUS)-guided drug-eluting stent (DES) implantation is associated with fewer major adverse cardiovascular events compared with angiography guidance for patients with individual lesion subset. However, the beneficial effect on major adverse cardiovascular event 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 1,448 all-comer patients who required DES implantation were randomly assigned (1:1 ratio) to either an IVUS guidance or angiography guidance group. The primary endpoint was target-vessel failure (TVF) at 12 months, including cardiac death, target-vessel myocardial infarction, and clinically driven target-vessel revascularization (TVR). The procedure was defined as a success if all IVUS-defined optimal criteria were met.
Results At 12 months follow-up, 60 TVFs (4.2%) 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 to 0.901; p = 0.019). In the IVUS group, TVF was recorded in 1.6% of patients with successful procedures, compared with 4.4% in patients who failed to achieve all optimal criteria (HR: 0.349; 95% CI: 0.135 to 0.898; p = 0.029). The significant reduction of clinically driven target-lesion revascularization or definite stent thrombosis (HR: 0.407; 95% CI: 0.188 to 0.880; p = 0.018) based on lesion-level analysis by IVUS guidance was not achieved when the patient-level analysis was performed.
Conclusions The present study demonstrates that IVUS-guided DES implantation significantly improved clinical outcome in all-comers, particularly for patients who had an IVUS-defined optimal procedure, compared with angiography guidance. (Intravascular Ultrasound Guided Drug Eluting Stents Implantation in “All-Comers” Coronary Lesions [ULTIMATE]; NCT02215915)
↵∗ Drs. Zhang, Gao, and Kan contributed equally to this work.
The ULTIMATE trial was funded by the National Natural Science Foundation of China (grants 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). The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Listen to this manuscript's audio summary by Editor-in-Chief Dr. Valentin Fuster on JACC.org.
- Received August 15, 2018.
- Revision received September 13, 2018.
- Accepted September 13, 2018.
- 2018 American College of Cardiology Foundation
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