Key result
Firehawk SES shows no difference in 5-year target lesion failure versus XIENCE EES regardless of diabetes.
Why the study?
Patients with diabetes mellitus undergoing PCI face high risks of restenosis and late stent thrombosis. The Firehawk abluminal biodegradable-polymer sirolimus-eluting stent is designed to minimize inflammation and enhance vascular healing, which could potentially improve 5-year outcomes compared with the XIENCE everolimus-eluting stent in these patients.
Does an abluminal biodegradable-polymer sirolimus-eluting stent reduce 5-year target lesion failure compared to a durable-polymer everolimus-eluting stent in patients with and without diabetes mellitus undergoing PCI?
RCT (n=1,651)
1:1
Yes
Does an abluminal biodegradable-polymer sirolimus-eluting stent reduce 5-year target lesion failure compared to a durable-polymer everolimus-eluting stent in patients with and without diabetes mellitus undergoing PCI?
At 5 years, the biodegradable-polymer sirolimus-eluting stent and durable-polymer everolimus-eluting stent demonstrated similar rates of target lesion failure in patients with diabetes, who remain at higher risk for adverse events than non-diabetic patients regardless of stent type.
Answers are grounded in this paper and cite their sources.
DM patients retain higher 5-year TLF, death, and TLR risk after contemporary DES; leaves open stent-specific effects in this subgroup.
BACKGROUND: Patients with diabetes mellitus (DM) undergoing PCI are at high risk of restenosis and late stent thrombosis. The Firehawk stent (abluminal biodegradable-polymer sirolimus-eluting stent [SES]) is designed to minimize inflammation and enhance vascular healing, which may improve outcomes in patients with DM. AIMS: In this subgroup analysis of the TARGET All Comers trial, we compared 5-year outcomes of patients based on diabetes status treated with the Firehawk SES versus XIENCE everolimus-eluting stent (EES). METHODS: TARGET All Comers randomized patients 1:1 to Firehawk or XIENCE. In this analysis, we compare non-stratified outcomes in DM versus non-DM patients overall and based on stent type. The primary end point was target lesion failure (TLF) at 5 years, a composite of cardiac death, target vessel myocardial infarction (TVMI), or ischemia-driven target lesion revascularization (TLR). Secondary end points included components of the primary outcome and definite/probable stent thrombosis. RESULTS: Of the 1651 patients enrolled, 388 (23%) had DM (197 Firehawk and 191 XIENCE) and 1263 (77%) had no DM (624 Firehawk and 639 XIENCE). Patients with DM were older, had more hypertension, hyperlipidemia, and more prior coronary interventions. Compared with non-DM patients, TLF (p < 0.001), cardiac death (p < 0.001), TVMI (p = 0.002), ischemia-driven TLR (p < 0.001), and definite/probable stent thrombosis (p = 0.008) were more frequent in patients with DM. There were no differences in primary or secondary end points between Firehawk and XIENCE in patients with or without DM. CONCLUSION: This subgroup analysis of the multicenter TARGET All Comers trial shows that at 5 years, the rate of TLF among patients with DM was similar with the Firehawk SES and the XIENCE EES. Our analysis demonstrates that regardless of stent type, patients with DM have higher rates of TLF.
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Hussain et al. (2026) conducted an RCT in Diabetes mellitus in patients undergoing percutaneous coronary intervention (n=1,651). Firehawk abluminal biodegradable-polymer sirolimus-eluting stent (SES) vs. XIENCE durable-polymer everolimus-eluting stent (EES) was evaluated on Target lesion failure (TLF) at 5 years (composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) (p=< 0.001 (DM vs non-DM)). Firehawk SES and XIENCE EES showed no difference in 5-year target lesion failure in patients with or without diabetes, though diabetes increased TLF risk overall (p<0.001).
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