Chao Gao, Xingqiang He, Fan Ouyang, Zhihui Zhang, Guidong Shen, Mingxing Wu, Ping Yang, Likun Ma, Feng Yang, Zheng Ji, Hua Wang, Yanqing Wu, Zhenfei Fang, Hong Jiang, Shangyu Wen, Yi Liu, Fei Li, Jingyu Zhou, Bin Zhu, Yunpeng Liu, Ruining Zhang, Tingting Zhang, Ping Wang, Jianzheng Liu, Zhiwei Jiang, Jielai Xia, Robert-Jan van Geuns, Davide Capodanno, Scot Garg, Yoshinobu Onuma, Duolao Wang, Patrick W Serruys, Ling Tao
BACKGROUND: The long-term impact of drug-coated balloon (DCB) angioplasty for the treatment of patients with de novo coronary artery lesions remains uncertain. We aimed to assess the non-inferiority of DCB angioplasty with rescue stenting to intended drug-eluting stent (DES) deployment for patients with de novo, non-complex coronary artery lesions. METHODS: REC-CAGEFREE I was an open-label, randomised, non-inferiority trial conducted at 43 sites in China. After successful lesion pre-dilatation, patients aged 18 years or older with de novo, non-complex coronary artery disease (irrespective of target vessel diameter) and an indication for percutaneous coronary intervention were randomly assigned (1:1), via a web-based centralised system with block randomisation (block size of two, four, or six) and stratified by site, to paclitaxel-coated balloon angioplasty with the option of rescue stenting due to an unsatisfactory result (DCB group) or intended deployment of second-generation thin-strut sirolimus-eluting stents (DES group)...
August 30, 2024: Lancet