title: 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.
abstract: OBJECTIVE
  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.
authors: Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, China.
authors: Zhan
authors: Z
authors: Gao
authors: Ruiyan
authors: R
authors: Zhang
authors: Bo
authors: B
authors: Xu
authors: Yuejin
authors: Y
authors: Yang
authors: Changsheng
authors: C
authors: Ma
authors: Hui
authors: H
authors: Li
authors: Shaoliang
authors: S
authors: Chen
authors: Yaling
authors: Y
authors: Han
authors: Zuyi
authors: Z
authors: Yuan
authors: Alexandra J
authors: AJ
authors: Lansky
authors: Changdong
authors: C
authors: Guan
authors: Martin B
authors: MB
authors: Leon
authors: Runlin
authors: R
authors: Gao
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D002681:China; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011108:Polymers / Q000737:chemistry*; D011446:Prospective Studies; D011474:Prosthesis Design; D016032:Randomized Controlled Trials as Topic; D012042:Registries; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D011108:Polymers; D020123:Sirolimus
keywords: abluminal groove; biodegradable polymer; objective performance criterion; percutaneous coronary intervention