title: 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.
abstract: OBJECTIVE
  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.
  
  
  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).
authors.affiliation: Fu Wai Hospital, National Center for Cardiovascular Diseases of China, Beijing, China. gaorunlin@citmd.com
authors.forename: Run-Lin
authors.initials: RL
authors.lastname: Gao
authors.forename: Bo
authors.initials: B
authors.lastname: Xu
authors.forename: Alexandra J
authors.initials: AJ
authors.lastname: Lansky
authors.forename: Yue-Jin
authors.initials: YJ
authors.lastname: Yang
authors.forename: Chang-Sheng
authors.initials: CS
authors.lastname: Ma
authors.forename: Ya-Ling
authors.initials: YL
authors.lastname: Han
authors.forename: Shao-Liang
authors.initials: SL
authors.lastname: Chen
authors.forename: Hui
authors.initials: H
authors.lastname: Li
authors.forename: Rui-Yan
authors.initials: RY
authors.lastname: Zhang
authors.forename: Guo-Sheng
authors.initials: GS
authors.lastname: Fu
authors.forename: Zu-Yi
authors.initials: ZY
authors.lastname: Yuan
authors.forename: Hong
authors.initials: H
authors.lastname: Jiang
authors.forename: Yong
authors.initials: Y
authors.lastname: Huo
authors.forename: Wei
authors.initials: W
authors.lastname: Li
authors.forename: Yao-Jun
authors.initials: YJ
authors.lastname: Zhang
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D000704:Analysis of Variance; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D002681:China; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000209:etiology / Q000401:mortality; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D003328:Coronary Thrombosis / Q000209:etiology / Q000401:mortality; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D006801:Humans; D016018:Least-Squares Analysis; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000401:mortality; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011108:Polymers; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011474:Prosthesis Design; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D011108:Polymers; D000068338:Everolimus; D020123:Sirolimus