Key result
The Firehawk stent was non-inferior to the Xience stent in terms of neointimal thickness at 6 months in patients with STEMI (absolute difference -5.94 µm, P<0.001 for noninferiority).
Why the study?
The vascular healing response of the Firehawk stent in patients with STEMI remains unclear.
Does the Firehawk biodegradable polymer sirolimus-eluting stent provide non-inferior vascular healing (neointimal thickness) compared to the Xience durable polymer everolimus-eluting stent in patients with STEMI?
RCT (n=44)
1:1
Yes
Does the Firehawk biodegradable polymer sirolimus-eluting stent provide non-inferior vascular healing (neointimal thickness) compared to the Xience durable polymer everolimus-eluting stent in patients with STEMI?
Mean Difference: -5.94
Absolute Event Rate: 73.03% vs 78.96%
p-value: p=<0.001 for noninferiority
In patients with STEMI, the biodegradable polymer sirolimus-eluting Firehawk stent demonstrated non-inferior vascular healing at 6 months compared to the durable polymer everolimus-eluting Xience stent.
Supports Firehawk as noninferior alternative to Xience in STEMI; extends RCT data on biodegradable-polymer stents for vascular healing.
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 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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He et al. (2022) conducted an RCT in ST-segment elevation myocardial infarction (STEMI) (n=44). Firehawk stent vs. Xience stent was evaluated on Neointimal thickness (NIT) at 6 months evaluated by OCT (MD -5.94, 95% CI -23.09 (lower bound), p=<0.001 for noninferiority). The Firehawk stent was non-inferior to the Xience stent in terms of neointimal thickness at 6 months in patients with STEMI (absolute difference -5.94 µm, P<0.001 for noninferiority).
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