Robot-assisted percutaneous coronary intervention:a prospe-ctive,multicenter,randomized controlled,non-inferiority clini-cal trial
Yi YU1
Zheng CHEN1
Zhi-Jian WANG1
Yue-Ping LI1
Li-Xia YANG1
Jing QI1
Jing XIE2
Tao HUANG2
Dong-Mei SHI1
Yu-Jie ZHOU1
1.Department of Cardiology,Beijing Anzhen Hospital,Capital Medical University,Beijing Institute of Heart Lung and Blood Vessel Disease,Beijing Key Laboratory of Precision Medicine of Coronary Atherosclerotic Disease,Clinical Center for Cor-onary Heart Disease,Capital Medical University,Beijing,China2.Beijing WeMed Medical Equipment Co.,Ltd.,Beijing,China
摘要：OBJECTIVE To evaluate the safety and effectiveness of robot-assisted percutaneous coronary intervention(R-PCI)compared to tr-aditional manual percutaneous coronary intervention(M-PCI).
METHODS This prospective,multicenter,randomized controlled,non-inferior clinical trial enrolled patients with coronary heart disease who met the inclusion criteria and had indications for elective percutaneous coronary intervention.Participants were random-ly assigned to either the R-PCI group or the M-PCI group.Primary endpoints were clinical and technical success rates.Clinical su-ccess was defined as visually estimated residual post-percutaneous coronary intervention stenosis＜30％with no 30-day major adve-rse cardiac events.Technical success in the R-PCI group was defined as successful completion of percutaneous coronary intervention using the ETcath200 robot-assisted system,without conversion to M-PCI in the event of a guidewire or balloon/stent catheter that was unable to cross the vessel or was poorly supported by the catheter.Secondary endpoints included total procedure time,percutaneous coronary intervention procedure time,fluoroscopy time,contrast volume,operator radiation exposure,air kerma,and dose-area pro-duct.
RESULTS The trial enrolled 152 patients(R-PCI:73 patients,M-PCI:79 patients).Lesions were predominantly B2/C type(73.6％).Both groups achieved 100％clinical success rate.No major adverse cardiac events occurred during the 30-day follow-up.The R-PCI gr-oup had a technical success rate of 100％.The R-PCI group had longer total procedure and fluoroscopy times,but lower operator ra-diation exposure.The percutaneous coronary intervention procedure time,contrast volume,air kerma,and dose-area product were similar between the two groups.
CONCLUSIONS For certain complex lesions,performing percutaneous coronary intervention using the ETcath200 robot-assist-ed system is safe and effective and does not result in conversion to M-PCI.
机标关键词：percutaneoustrialclini-calcontrolledcoronaryinterventionmulticenternon-inferiority
论文发表日期：2025-08-30
在线出版日期：2025-09-22（本平台首次上网日期，不代表文献的发表时间）
页数：11( 725-735 )