title: Optical coherence tomography assessment of a PLGA-polymer with electro-grafting base layer versus a PLA-polymer sirolimus-eluting stent at three-month follow-up: the BuMA-OCT randomised trial.
abstract: OBJECTIVE
  To compare stent strut coverage using optical coherence tomography (OCT) at three-month follow-up between a PLGA-polymer with electro-grafting base layer sirolimus-eluting stent (SES) (BuMA) and a PLA-polymer SES (EXCEL).
  
  
  RESULTS
  This prospective, single-centre, non-inferiority randomised BuMA-OCT trial enrolled patients with de novo coronary artery lesions, treated with either the BuMA or the EXCEL stent. The study primary endpoint was OCT-evaluated stent strut coverage at three months. Secondary endpoints were neointimal thickness of stent struts, and incomplete stent apposition evaluated with OCT. A total of 80 patients were randomly assigned to receive the BuMA (n=40) or the EXCEL (n=40) stent. In OCT follow-up (achieved in 86.3% of cases: BuMA, n=33; EXCEL, n=36), the percentage of stent strut coverage was significantly higher in the BuMA vs. the EXCEL group (strut level: 94.2% vs. 90.0%, p<0.01; p(non-inferiority)<0.0001; p(superiority) <0.0001), while the proportion of malapposed struts (strut level: 1.28% vs. 1.80%, p=0.51) and the mean neointimal thickness (strut level: 0.07±0.03 mm vs. 0.06±0.02 mm, p=0.31) were similar. Rates of myocardial infarction (periprocedural non-Q-wave, 7.5% vs. 7.5%, p=1.00) and target lesion failure (7.5% vs. 7.5%, p=1.00) were similar between groups, with no cardiac death or stent thrombosis.
  
  
  CONCLUSIONS
  In the BuMA-OCT randomised trial, the novel BuMA PLGA-polymer with electro-grafting base layer SES was superior to the EXCEL PLA-polymer SES in the primary endpoint of stent strut coverage at three-month follow-up.
authors.affiliation: Department of Cardiology, FuWai Hospital, National Center for Cardiovascular Diseases, Beijing, China.
authors.forename: Jie
authors.initials: J
authors.lastname: Qian
authors.forename: Yao-Jun
authors.initials: YJ
authors.lastname: Zhang
authors.forename: Bo
authors.initials: B
authors.lastname: Xu
authors.forename: Yue-Jin
authors.initials: YJ
authors.lastname: Yang
authors.forename: Hong-Bing
authors.initials: HB
authors.lastname: Yan
authors.forename: Zhong-Wei
authors.initials: ZW
authors.lastname: Sun
authors.forename: Ye-Lin
authors.initials: YL
authors.lastname: Zhao
authors.forename: Yi-Da
authors.initials: YD
authors.lastname: Tang
authors.forename: Zhan
authors.initials: Z
authors.lastname: Gao
authors.forename: Jue
authors.initials: J
authors.lastname: Chen
authors.forename: Jin-Gang
authors.initials: JG
authors.lastname: Cui
authors.forename: Gary S
authors.initials: GS
authors.lastname: Mintz
authors.forename: Run-Lin
authors.initials: RL
authors.lastname: Gao
mesh_terms: D000368:Aged; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D019344:Lactic Acid / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention; D011091:Polyesters / Q000008:administration & dosage; D011100:Polyglycolic Acid / Q000008:administration & dosage*; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D011446:Prospective Studies; D020123:Sirolimus / Q000008:administration & dosage*; D041623:Tomography, Optical Coherence / Q000379:methods*
chemical_list: D011091:Polyesters; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D011100:Polyglycolic Acid; D019344:Lactic Acid; C033616:poly(lactide); D020123:Sirolimus