New Ultrasound-Controlled Paclitaxel Releasing Balloon vs. Asymmetric Drug-Eluting Stent in Primary ST-Segment Elevation Myocardial Infarction　― A Prospective Randomized Trial

• Published in: Circulation Journal 2022/03/25, Vol.86(4), pp.642-650
• Main Authors: Wang, Zhiyong, Yin, Yuxia, Li, Jianfei, Qi, Wantao, Yu, Bo, Xu, Zhiru, Zhu, Wangliang, Yang, Fa, Cao, Mingkun, Zhang, Haijun
• Format: Article
• Language: English
• Subjects: Angioplasty, Balloon, Coronary - methods; Drug-coated balloons; Drug-Eluting Stents; Humans; Late lumen loss; Major adverse cardiovascular events; Paclitaxel - adverse effects; Percutaneous Coronary Intervention - adverse effects; Prospective Studies; ST Elevation Myocardial Infarction - diagnostic imaging; ST Elevation Myocardial Infarction - therapy; ST-segment elevation myocardial infarction; Treatment Outcome
• ISSN: 1346-9843; 1347-4820; 1347-4820
• DOI: 10.1253/circj.CJ-21-0315

Background:Application of drug-coated balloons (DCBs) is popular for the treatment of percutaneous coronary intervention (PCI). A new DCB has been designed as ultrasound-controlled paclitaxel releasing. This study was conducted to determine whether a DCB-only strategy has a similar safety profile and equal angiographic and clinical outcomes to DES implantation in primary ST-elevation myocardial infarction (STEMI) patients, as well as determine the efficiency and safety of this new DCB.Methods and Results:Overall, 184 pretreated STEMI patients were randomized into DCB and DES groups with a 1:1 allocation. The main study end-point was late lumen loss (LLL) during the 9 months after PCI. Late lumen loss was reported to be 0.24±0.39 mm in the DCB group and 0.31±0.38 mm in the DES group (P=0.215). Diameter stenosis was 28.27±15.35% in the DCB group and 25.73±15.41% in the DES group (P=0.312). Major adverse cardiovascular events (MACEs) were reported in 3 patients (3.4%) in the DCB group and 4 patients (4.7%) in the DES group (P=0.718). TLR and TVR in the DCB group was 2.3%, 3.4% and 2.4%, 3.5% in the DES group (P=1.000), respectively. No cardiac death and stent thrombosis (ST) was found in the DCB group at 12 months clinical follow up.Conclusions:The DCB-only strategy showed good angiographic and clinical outcomes in the 9- and 12-month follow-up periods, respectively. The VasoguardTM DCB is safe and feasible to treat STEMI patients.