火鹰支架与依维莫司洗脱支架在ST段抬高型心肌梗死患者6个月随访时愈合反应的随机对照比较（TARGET STEMI OCT中国试验）：一项光学相干断层扫描研究
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.
作者信息
He Yuan, Wang Rutao, Liu Jianzheng, Li Fei, Li Jiayi, Li Chengxiang, Zhou Jingyu, Zhao Zhijing, Yang Wangwei, Mou Fangjun, Wang Jing, Kan Jing, Li Xiaobo, Li Yan, Zheng Ming, Chen Shaoliang, Gao Chao, Tao Ling
机构信息
Department of Cardiology, Xijing Hospital, Air Force Medical University, Xi'an, China.
Department of Cardiology, Radboud University, Nijmegen, Netherlands.
出版信息
Front Cardiovasc Med. 2022 Jun 1;9:895167. doi: 10.3389/fcvm.2022.895167. eCollection 2022.
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]; < 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]%, = 0.804), the percentage of malapposed struts (0.17 [0.00, 1.52]% vs. 0.17 [0.00, 0.69]%, = 0.662), and the healing score (1.56 [0.23, 5.74] vs. 2.12 [0.91, 3.81], = 0.647). At 12 months, one patient in the Firehawk group experienced a clinically indicated target lesion revascularization. No other TLF events occurred in both groups. Independent risk factors of the NIT included body mass index, hyperlipidemia, B2/C lesions, thrombus G3-G5, thrombus aspiration, and postdilation pressure.
CONCLUSION
In patients with STEMI, Firehawk was non-inferior to Xience in vascular healing at 6 months. Both stents exhibited nearly complete strut coverage, moderate neointimal formation, and minimal strut malapposition.
CLINICAL TRIAL NUMBER
NCT04150016.
背景
火鹰支架在ST段抬高型心肌梗死（STEMI）患者中的愈合反应尚不清楚。
目的
我们比较了STEMI患者经皮冠状动脉介入治疗（PCI）后6个月时，生物可降解聚合物西罗莫司洗脱支架（火鹰）与耐用聚合物依维莫司洗脱支架（雅培Xience）的血管愈合情况。
方法
在这项前瞻性、多中心、随机、非劣效性研究中，STEMI发病12小时内的患者按1:1比例随机接受火鹰或雅培Xience支架。在首次手术后6个月进行光学相干断层扫描（OCT）随访，并逐帧评估。主要终点是通过OCT评估的6个月时的新生内膜厚度（NIT）。安全终点是12个月时的靶病变失败（TLF）。
结果
在新生内膜厚度方面，火鹰支架不劣于雅培Xience支架（73.03±33.30μm对78.96±33.29μm；绝对差异：-5.94[单侧95%置信下限：-23.09]；P<0.001）。火鹰组和雅培Xience组在未覆盖支架百分比（0.55[0.08，1.32]%对0.40[0.21，1.19]%，P=0.804）、贴壁不良支架百分比（0.17[0.00，1.52]%对0.17[0.00，0.69]%，P=0.662）和愈合评分（1.56[0.23,5.74]对2.12[0.91,3.81]，P=0.647）方面未观察到显著差异。在12个月时，火鹰组有1例患者进行了临床指征的靶病变血运重建。两组均未发生其他TLF事件。NIT的独立危险因素包括体重指数、高脂血症、B2/C型病变、血栓G3 - G5级、血栓抽吸和后扩张压力。
结论
在STEMI患者中，火鹰支架在6个月时的血管愈合方面不劣于雅培Xience支架。两种支架均表现出几乎完全的支架覆盖、适度的新生内膜形成和最小程度的支架贴壁不良。
临床试验编号
NCT04150016。
Zotero 插件