Leone Pier Pasquale, Colombo Antonio
Division of Cardiology, Montefiore Medical Center, Bronx, NY, USA.
Department of Biomedical Sciences, Humanitas University, Milan, Italy.
Eur Heart J Suppl. 2025 Apr 16;27(Suppl 3):iii79-iii82. doi: 10.1093/eurheartjsupp/suaf020. eCollection 2025 Mar.
REC-CAGEFREE I is a randomized open-label trial conducted in 2272 patients with non-complex coronary artery disease in China, which demonstrated that a strategy of paclitaxel-coated drug-eluting balloon angioplasty [Swide (Shenqi Medical, Shanghai, China)] and bail-out stent did not achieve non-inferiority to sirolimus-eluting stent implantation [Firebird 2 (Microport, Shanghai, China)] on the primary composite endpoint, defined as cardiovascular death, target vessel myocardial infarction, or clinically and physiologically indicated target lesion revascularization, assessed at 2 years. In this manuscript, we report the salient data of this study, highlighting relevant details about the design, the type of lesions included, and the clinical implications of these results. The main limitation of this study is the evaluation of lesions where the drug-eluting stents have demonstrated excellent short- and long-term results.
REC-CAGEFREE I是一项在中国2272例非复杂性冠状动脉疾病患者中进行的随机开放标签试验，该试验表明，在2年时评估的主要复合终点（定义为心血管死亡、靶血管心肌梗死或临床和生理指征的靶病变血运重建）方面，紫杉醇涂层药物洗脱球囊血管成形术[Swide（中国上海神祺医疗）]和补救支架策略并不非劣于西罗莫司洗脱支架植入术[Firebird 2（中国上海微创）]。在本手稿中，我们报告了这项研究的主要数据，突出了有关设计、纳入病变类型以及这些结果的临床意义的相关细节。本研究的主要局限性在于对药物洗脱支架已显示出优异短期和长期结果的病变进行评估。
