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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

Authors
  • He, Yuan1
  • Wang, Rutao1, 2, 3
  • Liu, Jianzheng1
  • Li, Fei1
  • Li, Jiayi1
  • Li, Chengxiang1
  • Zhou, Jingyu1
  • Zhao, Zhijing1
  • Yang, Wangwei1
  • Mou, Fangjun1
  • Wang, Jing1
  • Kan, Jing4
  • Li, Xiaobo4
  • Li, Yan5
  • Zheng, Ming6
  • Chen, Shaoliang4
  • Gao, Chao1, 2, 3
  • Tao, Ling1
  • 1 Department of Cardiology, Xijing Hospital, Air Force Medical University, Xi'an , (China)
  • 2 Department of Cardiology, Radboud University, Nijmegen , (Netherlands)
  • 3 Department of Cardiology, National University of Ireland, Galway , (Ireland)
  • 4 Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing , (China)
  • 5 Department of Cardiology, Tangdu Hospital, Air Force Medical University, Xi'an , (China)
  • 6 Shanghai MicroPort Medical (Group), Shanghai , (China)
Type
Published Article
Journal
Frontiers in Cardiovascular Medicine
Publisher
Frontiers Media SA
Publication Date
Jun 01, 2022
Volume
9
Identifiers
DOI: 10.3389/fcvm.2022.895167
Source
Frontiers
Keywords
Disciplines
  • Cardiovascular Medicine
  • Original Research
License
Green

Abstract

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]; Pnon−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 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.

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