Junjie Zhang1, Xiaofei Gao2, Jing Kan2, Zhen Ge2, Leng Han3, Shu Lu4, Nailiang Tian2, Song Lin2, Qinghua Lu5, Xueming Wu6, Qihua Li7, Zhizhong Liu2, Yan Chen8, Xuesong Qian9, Juan Wang3, Dayang Chai4, Chonghao Chen6, Xiaolong Li7, Bill D Gogas10, Tao Pan2, Shoujie Shan2, Fei Ye2, Shao-Liang Chen11. 1. Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China. Electronic address: jameszll@163.com. 2. Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China. 3. Department of Cardiology, Changshu NO.1 People's Hospital, Changshu, China. 4. Department of Cardiology, The First People's Hospital of Taicang, Taicang, China. 5. Department of Cardiology, The Second Hospital of Shandong University, Jinan, China. 6. Department of Cardiology, Wuxi Third People's Hospital, Wuxi, China. 7. Department of Cardiology, Changzhou Traditional Chinese Medicine Hospital, Changzhou, China. 8. Department of Cardiology, Fuwai Central China Cardiovascular Hospital, Zhengzhou, China. 9. Department of Cardiology, The First People's Hospital of Zhangjiagang, Zhangjiagang, China. 10. Department of Cardiology, Emory University Hospital, Atlanta, Georgia. 11. Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China. Electronic address: chmengx@126.com.
Abstract
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).
RCT Entities:
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).
Authors: Harsha S Nagarajarao; Chandra P Ojha; Venkatachalam Mulukutla; Ahmed Ibrahim; Adriana C Mares; Timir K Paul Journal: Curr Cardiol Rep Date: 2020-02-08 Impact factor: 2.931
Authors: Ata Doost; James Marangou; Thato Mabote; Gerald Yong; Sharad Shetty; Alan Whelan; Matthew Erickson; Michael Nguyen; Christopher Judkins; Anthony Putrino; Abdul Rahman Ihdayhid; Richard Clugston; James Rankin Journal: AsiaIntervention Date: 2022-03-15
Authors: Tobias Wissel; Katharina A Riedl; Klaus Schaefers; Hannes Nickisch; Fabian J Brunner; Nikolas D Schnellbaecher; Stefan Blankenberg; Moritz Seiffert; Michael Grass Journal: J Med Imaging (Bellingham) Date: 2022-03-28