title: Biodegradable-polymer-based, sirolimus-eluting Supralimus stent: 6-month angiographic and 30-month clinical follow-up results from the series I prospective study.
abstract: OBJECTIVE
  There have been recent concerns regarding the long-term safety of the first generation of drug-eluting stents, which utilised a permanent polymer coating for drug delivery. SERIES I is a prospective, non-randomised, first-in-man open label study with the biodegradable polymer-based Supralimus sirolimus eluting stent (Sahajanand Medical Technologies Pvt. Ltd, India) for the treatment of patients with coronary artery lesions.
  
  
  RESULTS
  One hundred patients were treated with 126 Supralimus stents (mean lesion length 10.5 +/- 4.3 mm, mean reference vessel diameter 2.66 +/- 0.62 mm). The pre-specified primary endpoint was angiographic binary in-stent restenosis at six months. Secondary endpoints were device-orientated major adverse clinical events (MACE; defined as a composite of cardiac death, nonfatal myocardial infarction [Q-wave and Non-Q wave], or clinically-justified target vessel revascularisation) at 30 days, nine months and 30 months. Angiographic follow-up in a pre-specified subgroup of 60 patients at six months showed binary angiographic restenosis rates of 0% (in-stent) and 1.7% (in-segment). The in-stent late loss was 0.09 +/- 0.37 mm. MACE rates were 0% after one month, 6% at 9-month follow-up and 7% after 30 months follow-up.
  
  
  CONCLUSIONS
  The biodegradable-polymer-based sirolimus-eluting stent (Supralimus) is effective in inhibiting neointimal hyperplasia.
authors.affiliation: SAL Hospital & Medical Institute, Ahmedabad, India. danisameer@hotmail.com
authors.forename: Sameer
authors.initials: S
authors.lastname: Dani
authors.forename: Neville
authors.initials: N
authors.lastname: Kukreja
authors.forename: Prakashvir
authors.initials: P
authors.lastname: Parikh
authors.forename: Hasit
authors.initials: H
authors.lastname: Joshi
authors.forename: Jayesh
authors.initials: J
authors.lastname: Prajapati
authors.forename: Sharad
authors.initials: S
authors.lastname: Jain
authors.forename: Sunil
authors.initials: S
authors.lastname: Thanvi
authors.forename: Bhupesh
authors.initials: B
authors.lastname: Shah
authors.forename: Jyoti-Prakash
authors.initials: JP
authors.lastname: Dutta
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage*; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D003327:Coronary Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D018572:Disease-Free Survival; D054855:Drug-Eluting Stents / Q000009:adverse effects; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D011108:Polymers; D011446:Prospective Studies; D020123:Sirolimus / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D000903:Antibiotics, Antineoplastic; D020099:Coated Materials, Biocompatible; D011108:Polymers; D020123:Sirolimus