AIMS: The Firehawk is a thin-strut coronary stent with a sirolimus and biodegradable polymer complex that are localized in abluminal grooves. The TARGET All Comers study found similar safety and efficacy of the Firehawk compared with the durable polymer everolimus-eluting XIENCE stent at 1- and 2-years follow-up. The aim of this study was to assess comparative clinical outcomes at 3 years.
METHODS AND RESULTS: The TARGET All Comer study is a prospective, multicenter, randomized, non-inferiority trial. A total of 1653 patients were randomly allocated to receive either the Firehawk or XIENCE stent. The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization. At 3-year follow-up, TLF occurred in 11.9% in the Firehawk group and 11.5% in the XIENCE group (p=0.84). The event rates of individual components of TLF were comparable for the 2 groups. Landmark analyses between 1 and 3 years showed no significant difference of TLF for the Firehawk versus XIENCE stent. The incidence of very late definite or probable stent thrombosis was 0.8% in the Firehawk group and 1.4% in the XIENCE group (p=0.24).
CONCLUSIONS: The 3-year follow-up of the TARGET All Comers study showed comparable safety and efficacy profiles of the biodegradable polymer Firehawk and the durable polymer XIENCE stent.