Final 5‐Year Results of Abluminal Groove‐Filled Biodegradable‐Polymer Sirolimus‐Eluting Stent Versus Durable‐Polymer Everolimus‐Eluting Stent in Patients With Diabetes: Results of the TARGET AC Trial

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.