Lansky A, et al. - In an all-comers population, researchers gauged the clinical outcomes with FIREHAWK, a targeted, low-dose, biodegradable polymer, sirolimus-eluting stent vs XIENCE durable polymer, everolimus-eluting stents. On the primary endpoint of target lesion failure at 12 months and in-stent late lumen loss at 13 months, the FIREHAWK was non-inferior to the XIENCE in this study of patients requiring stent implantation for myocardial ischemia. In clinical practice, the FIREHAWK was seen to be a safe and efficacious alternative stent for patients with ischemic coronary artery disease.

Methods

• Experts conducted the TARGET All Comers study, a prospective, multicenter, open-label randomized non-inferiority trial at 21 centers in 10 European countries.
• They randomly allocated 1:1 patients with symptomatic or asymptomatic coronary artery disease and objective evidence of myocardial ischemia who qualified for percutaneous coronary intervention to undergo implantation of a FIREHAWK or XIENCE.
• They carried out web-based randomization, with random block allocation and stratification by center and ST elevation myocardial infarction.
• The primary endpoint included target lesion failure at 12 months, a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization.
• They assumed the control event rate for XIENCE to be 7%, the non-inferiority margin was 3.5%, and the primary analysis was in the intention-to-treat population, censoring patients who did not have either an event before 365 days or contact beyond 365 days.
• The primary endpoint of an angiographic substudy designed to investigate the non-inferiority of the FIREHAWK compared with the XIENCE stent was late lumen loss.

Results

• As per data, from December 17, 2015, to October 14, 2016, 1,653 patients were randomly assigned to implantation of the FIREHAWK (n=823) or XIENCE (n=830).
• In the FIREHAWK group, 65 patients and in the XIENCE group 66 patients had insufficient follow-up data and were excluded from the analyses.
• Findings suggested that, at 12 months, target lesion failure occurred in 46 (6.1%) of 758 patients in the FIREHAWK group and in 45 (5.9%) of 764 patients in the XIENCE group (difference 0.2%, 90% CI -1.9 to 2.2, p_{non-inferiority}=0.004, 95% CI -2.2 to 2.6, p_superiority=0.88).
• At 12 months, ischemia-driven revascularization or stent thrombosis rates did not display any differences between the two stents.
• Results show that 176 patients were included in the angiographic substudy, in which in-stent late lumen loss was 0.17 mm (SD 0.48) in the FIREHAWK group and 0.11 mm (0.52) in the XIENCE group (p=0.48), with an absolute difference of 0.05 mm (95% CI -0.09 to 0.18, p_{non-inferiority}=0.024).