title: Feasibility of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent in patients with complex anatomical and clinical scenarios.
abstract: OBJECTIVE
  We aimed to investigate the feasibility, initial safety and efficacy of coronary intervention using FIREHAWK®, a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent (SES), in patients with complex anatomical and clinical scenarios.
  
  
  METHODS
  A total of 57 patients (79 lesions) with complex anatomical and clinical scenarios implanted with the FIREHAWK® SES between March and November 2014 were studied. The primary endpoint was target lesion failure (TLF), a composite endpoint of cardiac death, target vessel-myocardial infarction (TV-MI), and ischemia-driven target lesion revascularization (iTLR). Optical coherence tomography and intravascular ultrasound was performed according to the discretion of operators.
  
  
  RESULTS
  28.1% of patients presented acute myocardial infarction and all patients had at least one of the following anatomical and locational complexity: multi-vessel disease (64.9%), left main disease (24.6%), chronic total occlusion (17.5%), bifurcation (56.1%), and heavily calcified lesions (10.5%). One patients experienced coronary perforation during the procedure and resolved without any additional treatment. Device success was 100%, clinical success was 100%. There was 1 (1.8%) TLF occurred at follow-up of 150 ± 65 days. One patients had non-iTLR. Out of 2 non-Q-wave MI, 1 patient experienced TV-MI, but no death and stent thrombosis were reported. OCT and IVUS imaging showed a high rate of covered struts and low neointimal hyperplasia at follow-up.
  
  
  CONCLUSIONS
  The study showed the feasibility, initial safety and efficacy of coronary intervention using FIREHAWK® SES for treating patients with complex anatomical and clinical scenarios. The performance of the FIREHAWK® SES in complex patients justifies the conduct of a large, randomized trial.
authors: Department of Cardiology, Nanjing First Hospital Nanjing Medical University, Nanjing, China - chmengx126@gmail.com.
authors: Y J
authors: YJ
authors: Zhang
authors: W
authors: W
authors: Wu
authors: D R
authors: DR
authors: Pan
authors: B
authors: B
authors: Xu
authors: J
authors: J
authors: Kan
authors: Y X
authors: YX
authors: Chen
authors: S
authors: S
authors: Pang
authors: W
authors: W
authors: You
authors: J J
authors: JJ
authors: Zhang
authors: F
authors: F
authors: Ye
authors: S L
authors: SL
authors: Chen
mesh_terms: D000368:Aged; D003324:Coronary Artery Disease / Q000503:physiopathology / Q000628:therapy*; D054855:Drug-Eluting Stents; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000503:physiopathology / Q000628:therapy*; D017202:Myocardial Ischemia / Q000503:physiopathology / Q000628:therapy; D009204:Myocardial Revascularization; D011108:Polymers / Q000737:chemistry; D011474:Prosthesis Design; D020123:Sirolimus / Q000008:administration & dosage*; D041623:Tomography, Optical Coherence / Q000379:methods
chemical_list: D011108:Polymers; D020123:Sirolimus