title: First-in-man study evaluating the safety and efficacy of a second generation biodegradable polymer sirolimus-eluting stent in the treatment of patients with de novo coronary lesions: clinical, Angiographic, and OCT outcomes of CREDIT-1.
abstract: OBJECTIVE
  To evaluate the preliminary safety and efficacy of the EXCEL II stent system.
  
  
  BACKGROUND
  Although the first biodegradable polymer drug-eluting stent (BP-DES), EXCEL, was launched nearly a decade ago, in-stent restenosis and stent thrombosis remain pertinent clinical problems in practice. A new cobalt-chromium BP-DES EXCEL II has been developed with the aim of improving stent safety and efficacy.
  
  
  METHODS
  Forty-five patients with single de novo native coronary lesions were enrolled and randomized to two groups in a 2:1 ratio, the 4-month follow-up group (n = 30) and the 12-month follow-up group (n = 15). All patients underwent percutaneous coronary intervention (PCI) with the EXCEL II stent system. Quantitative coronary angiography (QCA) and optical coherence tomography (OCT) were used to assess coronary vasculature at the designated 4- or 12-month follow-up. The primary outcome was major adverse cardiac events (MACE) at 30 days post-PCI.
  
  
  RESULTS
  No MACE, thrombotic events, or target lesion failure was found in the 45 patients during the 12-month follow-up. There was no significant difference (P > 0.05) between the two groups in terms of in-stent and in-segment late lumen loss (LLL). No in-stent and in-segment restenosis was found in either group. At follow-up, the ratio of >10% uncovered struts per lesion was 26.67% in the 4-month group and 0% in the 12-month group (P < 0.05). Neointimal coverage in the 12-month group was significantly better than in the 4-month group (98.58% vs. 93.51%, P < 0.01).
  
  
  CONCLUSIONS
  This first-in-man study demonstrates promising feasibility, safety, and efficacy of EXCEL II stents. These stents were found to have rapid endothelialization and low LLL rates at 4 and 12 months after implantation.
authors: Department of Cardiology, General Hospital of Shenyang Military Region, Shenyang, Liaoning, China.
authors: Geng
authors: G
authors: Wang
authors: Zhongwei
authors: Z
authors: Sun
authors: Quanmin
authors: Q
authors: Jin
authors: Kai
authors: K
authors: Xu
authors: Yi
authors: Y
authors: Li
authors: Xiaozeng
authors: X
authors: Wang
authors: Yingyan
authors: Y
authors: Ma
authors: Haiwei
authors: H
authors: Liu
authors: Xin
authors: X
authors: Zhao
authors: Bin
authors: B
authors: Wang
authors: Jie
authors: J
authors: Deng
authors: Shaoyi
authors: S
authors: Guan
authors: Meiling
authors: M
authors: Ge
authors: Xiaoyan
authors: X
authors: Wang
authors: Bo
authors: B
authors: Xu
authors: Yaling
authors: Y
authors: Han
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D002681:China; D002858:Chromium Alloys; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000473:pathology / Q000628:therapy*; D023903:Coronary Restenosis / Q000209:etiology; D003328:Coronary Thrombosis / Q000209:etiology; D003331:Coronary Vessels / Q000000981:diagnostic imaging / Q000187:drug effects* / Q000473:pathology; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D058426:Neointima; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation*; D011108:Polymers / Q000737:chemistry*; D011237:Predictive Value of Tests; D011474:Prosthesis Design; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage*; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D002858:Chromium Alloys; D011108:Polymers; D020123:Sirolimus
keywords: coronary artery disease; first-in-man study; optical coherence tomography; quantitative coronary angiography; sirolimus-eluting stent