Safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of de novo coronary lesions: two-year results from a prospective patient-level pooled analysis of TARGET trials.

OBJECTIVES: We aimed to evaluate the safety and effectiveness of the novel abluminal groove-filled biodegradable polymer-coated sirolimus-eluting FIREHAWK stent (MicroPort Medical, Shanghai, China) in a large cohort of patients. BACKGROUND: Trials on the FIREHAWK stent allowing targeted sirolimus release were not individually powered to reliably estimate low-frequency safety endpoints such as stent thrombosis (ST) or to examine long-term safety and efficacy. Additionally, the China Food and Drug Administration requires an objective performance criterion (OPC) study for new drug-eluting stents. METHODS: The primary endpoint, target lesion failure (TLF), was defined as the composite of cardiac death, target vessel myocardial infarction (MI), or clinically indicated target lesion revascularization at 12 months. Patient-level data from 1,007 patients with de novo native coronary lesions exclusively treated with the FIREHAWK stent in the TARGET serial studies (I and II) were prospectively collected, pooled and analyzed throughout a 2-year follow-up. RESULTS: The 12-month rate of TLF in 1,003 patients (follow-up rate, 99.6%) was 3.9% (upper 95% confidence interval (CI): 5.3%), which was significantly lower than the performance goal of 9.0% (P < 0.0001). The 24-month rates of TLF, PoCE (a composite of all-cause death, all MI, or any revascularization), and ARC definite or probable ST were 4.6%, 7.8% and 0.1%, respectively. In subgroup analysis, long lesion (≥ 30 mm) was an independent predictor of TLF within 2 years (hazard ratio [95%CI]: 2.44 [1.32, 4.53], P < 0.01). CONCLUSIONS: This pooled, patient-level analysis indicates that the FIREHAWK stent exhibits a promising 2-year efficacy and safety profile.

Safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of de novo coronary lesions: 12-month results from the TARGET II trial.

BACKGROUND: In the TARGET I randomized controlled trial, the novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent FIREHAWK proved non-inferior to the everolimus-eluting stent in nine-month in-stent late loss in single de novo coronary lesions. This study was aimed at evaluating clinical safety and effectiveness of FIREHAWK in a moderately complex population (including patients with small vessels, long lesions and multi-vessels), and at validating the ability of the SYNTAX score (SS) to predict clinical outcomes in patients treated with this latest generation drug-eluting stent. METHODS: TARGET II was a prospective, multicenter, single-arm study with primary outcome of 12-month target lesion failure (TLF), including cardiac death, target vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (TLR). Stent thrombosis was defined according to the Academic Research Consortium (ARC) definition. Patients were grouped by tertiles of SS (≤6, >6 to ≤12, and >12). All patients were exclusively treated with the FIREHAWK stent and were followed up at 1, 6, and 12 months, and annually thereafter up to five years. RESULTS: A total of 730 patients were included in this registry study. The 12-month incidence of TLF was 4.4% and the incidence of TLF components were, cardiac death 0.5%, TV-MI 3.2%, and TLR 2.2%. One definite/probable stent thrombosis was observed at 12-month follow-up. Mean SS was 10.87±6.87. Patients in the SS >12 tertile had significantly higher TLF (P = 0.02) and TLR (P < 0.01) rates than those in lower SS groups. In COX proportional-hazards regression analyses, TLF incidence was strongly related to lesion length (long lesion vs. non-long lesion patients; HR 3.416, 95% CI, 1.622-7.195), but unrelated to diabetic, small vessel, and multivessel subgroups. CONCLUSIONS: The low TLF incidence in this study indicates that FIREHAWK is safe and effective in the treatment of moderately complex coronary disease. SS is also able to predict adverse clinical outcomes in FIREHAWK treated patients.

A randomised comparison of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent: clinical and angiographic follow-up of the TARGET I trial.

AIMS: The study sought to evaluate the safety and efficacy of FIREHAWK, a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent (SES) for treating patients with single de novo coronary lesions compared with the durable polymer everolimus-eluting stent (EES) XIENCE V. METHODS AND RESULTS: A total of 458 patients with single de novo native coronary lesions ≤24 mm in length and a coronary artery ≥2.25 to ≤4.0 mm in diameter were enrolled in the TARGET I study, a prospective, randomised, non-inferiority trial. The primary endpoint was in-stent late lumen loss (LLL) at nine-month follow-up. The secondary endpoint, target lesion failure (TLF), was defined as the composite of cardiac death, target vessel myocardial infarction (TVMI), or ischaemia-driven target lesion revascularisation (iTLR). Patients were centrally randomised to treatment with either biodegradable polymer SES (n=227) or durable polymer EES (n=231). The nine-month in-stent LLL of the biodegradable polymer SES was comparable to the EES group (0.13 ± 0.24 mm vs. 0.13 ± 0.18 mm, p=0.94; difference and 95% confidence interval 0.00 [-0.04, 0.04] mm; p for non-inferiority <0.0001). Cardiac death (0.4% vs. 0.0%), TVMI (1.3% vs. 1.7%), iTLR (0.4% vs. 0.4%) and TLF (2.2% vs. 2.2%) were similar between the biodegradable polymer SES and durable polymer EES groups at 12-month follow-up (all p>0.05). No definite/probable stent thrombosis was observed in both of these groups. CONCLUSIONS: In the multicentre TARGET I trial, the novel abluminal groove-filled biodegradable polymer SES FIREHAWK was non-inferior to the durable polymer EES XIENCE V with respect to the primary endpoint of in-stent LLL at nine months for treating patients with single de novo coronary lesions. The incidences of clinical endpoints were low in both of the stents at 12-month follow-up. (ClinicalTrials.gov identifier: NCT01196819).