A Randomized Comparison of the Healing Response Between the Firehawk Stent and the Xience Stent in Patients With ST-Segment Elevation Myocardial Infarction at 6 Months of Follow-Up (TARGET STEMI OCT China Trial): An Optical Coherence Tomography Study

作者：Yuan He, Rutao Wang, Jianzheng Liu, Fei Li, Jiayi Li, Chengxiang Li, Jingyu Zhou, Zhijing Zhao, Wangwei Yang, Fangjun Mou, Jing Wang, Jing Kan, Xiaobo Li, Yan Li, Ming Zheng, Shao‐Liang Chen, Chao Gao, Ling Tao · 发表于：Frontiers in Cardiovascular Medicine · 年份：2022 · DOI：10.3389/fcvm.2022.895167 · 被引用次数：10 · 研究领域：Coronary Interventions and Diagnostics、Acute Myocardial Infarction Research、Peripheral Artery Disease Management

Background The healing response of the Firehawk stent in patients with ST-segment elevation myocardial infarction (STEMI) remains unclear. Aim We compared the vascular healing of a biodegradable polymer sirolimus-eluting stent (Firehawk) vs. a durable polymer everolimus-eluting stent (Xience) at 6 months after percutaneous coronary intervention (PCI) in patients with STEMI. Methods In this prospective, multicenter, randomized, non-inferiority study, patients within 12 h of STEMI onset were randomized in a ratio of 1:1 to receive Firehawk or Xience stents. Optical coherence tomography (OCT) follow-up was performed 6 months after the index procedure and assessed frame by frame. The primary endpoint was the neointimal thickness (NIT) at 6 months evaluated by OCT. The safety endpoint was target lesion failure (TLF) at 12 months. Results The Firehawk stent was non-inferior to the Xience stent in terms of the neointimal thickness (73.03 ± 33.30 μm vs. 78.96 ± 33.29 μm; absolute difference: −5.94 [one-sided 95% lower confidence bound: −23.09]; P non−inferiority < 0.001). No significant difference was observed between the Firehawk and Xience groups regarding the percentage of uncovered struts (0.55 [0.08, 1.32]% vs. 0.40 [0.21, 1.19]%, P = 0.804), the percentage of malapposed struts (0.17 [0.00, 1.52]% vs. 0.17 [0.00, 0.69]%, P = 0.662), and the healing score (1.56 [0.23, 5.74] vs. 2.12 [0.91, 3.81], P = 0.647). At 12 months, one patient in the Firehawk group experienced a cli...