Targeted therapy with a localized abluminal groove, low-dose sirolimus-eluting, biodegradable polymer coronary stent
A 10-country European trial compared clinical outcomes from two different kinds devices in a widely general population of stent candidates.
A 10-country European trial compared clinical outcomes from two different kinds devices in a widely general population of stent candidates. Roughly 1,650 patients with coronary artery disease and myocardial ischemia were recruited for the TARGET All Comers study, roughly one-half of whom were randomized to implantation with the FIREHAWK: a targeted, low-dose, drug-eluting stent. The FIREHAWK features a fully biodegradable sirolimus-containing polymer coating localized to recessed abluminal grooves on the device surface. The remaining participants were randomly assigned to XIENCE durable polymer, everolimus-eluting stents for comparison. Results for 1,522 of the 1,650 patients were included in the final analysis. The main outcome was target lesion failure at 12 months, which affected 6.1% of 758 patients who received FIREHAWK stents and 5.9% of 764 patients who underwent XIENCE implantation. Incidence of ischemia-driven revascularization and stent thrombosis was comparable between the two groups. Moreover, an angiographic substudy involving 176 patients revealed late lumen loss of 0.17 mm in the FIREHAWK group and of 0.11 mm in the XIENCE group. The findings indicate that the FIREHAWK is noninferior to the XIENCE and is a safe and effective alternative stent for patients with ischemic coronary artery disease.