Key result
The Firehawk stent resulted in similar rates of target lesion failure compared to the XIENCE stent at 2 years in both high-risk (9.9% vs 9.1%; P=0.57) and low-risk (3.1% vs 4.2%; P=0.66) patients.
Why the study?
Although the Firehawk stent showed similar results to XIENCE in an all-comers trial, its clinical outcomes in high-risk patients remained unclear.
Does a biodegradable polymer sirolimus-eluting stent reduce target lesion failure compared to a durable polymer everolimus-eluting stent in high-risk and low-risk patients?
RCT (n=1,585)
randomized
Does a biodegradable polymer sirolimus-eluting stent reduce target lesion failure compared to a durable polymer everolimus-eluting stent in high-risk and low-risk patients?
A biodegradable polymer sirolimus-eluting stent performs similarly to a durable polymer everolimus-eluting stent at 2 years, regardless of patient risk complexity.
Clinicians may select either stent by non-efficacy factors; extends RCT evidence of comparable performance across risk strata.
BACKGROUND: The Firehawk stent (Shanghai MicroPort Medical Group, Shanghai, China), a novel biodegradable polymer sirolimus-eluting coronary stent has been evaluated in the randomized TARGET I trial in which low-risk patients were enrolled with strict eligibility criteria. Recently, the TARGET All Comers study has shown similar results of the Firehawk compared to the XIENCE stent (Abbott Vascular, Santa Clara). However, clinical outcomes in high-risk patients are unclear. METHODS: The TARGET All Comer study was a randomized trial that assigned patients to either Firehawk or XIENCE implantation. This TARGET AC subanalysis sought to evaluate the 2 year clinical outcomes of patients according to two risk groups; patients meeting all inclusion criteria and no exclusion criteria of the TARGET I trial were classified as "low-risk," while their counterparts were classified as "high-risk." The primary endpoint was target lesion failure. RESULTS: A total of 1,585 patients were included, of which 1,334 (84%) were classified as high-risk. At 2 years, the high-risk group had a significantly higher rate of TLF than the low-risk group (9.5% vs. 3.6%, p = .003), mainly driven by increased target vessel myocardial infarction (6.3% vs. 2.4%, p = .02). The Firehawk and XIENCE had no significant differences in TLF among both low-risk (3.1% vs. 4.2%, p = .66) and high-risk (9.9% vs. 9.1%, p = .57) patients. CONCLUSIONS: High-risk patients had worse clinical outcomes at 2 years in the TARGET All Comer study. Outcomes with the Firehawk were similar to the XIENCE stent among both low-risk and high-risk patients at 2 years.
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Saito et al. (2019) conducted an RCT in complex coronary lesions (n=1,585). Firehawk biodegradable polymer sirolimus-eluting stent vs. XIENCE durable polymer everolimus-eluting stent was evaluated on target lesion failure (high-risk patients) (p=0.57). The Firehawk stent resulted in similar rates of target lesion failure compared to the XIENCE stent at 2 years in both high-risk (9.9% vs 9.1%; P=0.57) and low-risk (3.1% vs 4.2%; P=0.66) patients.
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