title: The SSTARS (STeroids and Stents Against Re-Stenosis) Trial: Different stent alloys and the use of peri-procedural oral corticosteroids to prevent in-segment restenosis after percutaneous coronary intervention.
abstract: BACKGROUND
  Stent design and technological modifications to allow for anti-proliferative drug elution influence restenosis rates following percutaneous coronary intervention (PCI). We aimed to investigate whether peri-procedural administration of corticosteroids or the use of thinner strut cobalt alloy stents would reduce rates of binary angiographic restenosis (BAR) after PCI.
  
  
  METHODS
  This was a two centre, mixed single and double blinded, randomised controlled trial using a factorial design. We compared (a) the use of prednisolone to placebo, starting at least six hours pre-PCI and continued for 28days post-PCI, and (b) cobalt chromium (CoCr) to stainless steel (SS) alloy stents, in patients admitted for PCI. The primary end-point was BAR at six months.
  
  
  RESULTS
  315 patients (359 lesions) were randomly assigned to either placebo (n=145) or prednisolone (n=170) and SS (n=160) or CoCr (n=160). The majority (58%) presented with an ACS, 11% had diabetes and 287 (91%) completed angiographic follow up. BAR occurred in 26 cases in the placebo group (19.7%) versus 31 cases in the prednisolone group (20.0%) respectively, p=1.00. For the comparison between SS and CoCr stents, BAR occurred in 32 patients (21.6%) versus 25 patients (18.0%) respectively, p=0.46.
  
  
  CONCLUSIONS
  Our study showed that treating patients with a moderately high dose of prednisolone for 28days following PCI with BMS did not reduce the incidence of BAR. In addition, we showed no significant reduction in 6month restenosis rates with stents composed of CoCr alloy compared to SS (http://www.isrctn.com/ISRCTN05886349).
authors.affiliation: The James Cook University Hospital, South Tees Hospitals NHS Trust, Marton Rd, Middlesbrough TS4 3BW, United Kingdom. Electronic address: zulfiquar.adam@nhs.net.
authors.forename: Z
authors.initials: Z
authors.lastname: Adam
authors.affiliation: The James Cook University Hospital, South Tees Hospitals NHS Trust, Marton Rd, Middlesbrough TS4 3BW, United Kingdom.
authors.forename: A
authors.initials: A
authors.lastname: Turley
authors.affiliation: Warwick Medical School, University of Warwick, Coventry CV4 7AL, United Kingdom.
authors.forename: J M
authors.initials: JM
authors.lastname: Mason
authors.affiliation: School of Medicine, Pharmacy and Health, Durham University, Queen's Campus, Wolfson Research Institute, University Boulevard, Stockton-on-Tees TS17 6BH, United Kingdom.
authors.forename: A S
authors.initials: AS
authors.lastname: Kasim
authors.affiliation: Royal Infirmary of Edinburgh, Lothian University Hospitals NHS Trust, Old Dalkeith Road, Edinburgh EH16 4SA, United Kingdom.
authors.forename: D
authors.initials: D
authors.lastname: Newby
authors.affiliation: Royal Infirmary of Edinburgh, Lothian University Hospitals NHS Trust, Old Dalkeith Road, Edinburgh EH16 4SA, United Kingdom.
authors.forename: N
authors.initials: N
authors.lastname: Mills
authors.affiliation: Royal Infirmary of Edinburgh, Lothian University Hospitals NHS Trust, Old Dalkeith Road, Edinburgh EH16 4SA, United Kingdom.
authors.forename: G
authors.initials: G
authors.lastname: Padfield
authors.affiliation: The James Cook University Hospital, South Tees Hospitals NHS Trust, Marton Rd, Middlesbrough TS4 3BW, United Kingdom.
authors.forename: L
authors.initials: L
authors.lastname: Thompson
authors.affiliation: The James Cook University Hospital, South Tees Hospitals NHS Trust, Marton Rd, Middlesbrough TS4 3BW, United Kingdom.
authors.forename: R
authors.initials: R
authors.lastname: Morley
authors.affiliation: The James Cook University Hospital, South Tees Hospitals NHS Trust, Marton Rd, Middlesbrough TS4 3BW, United Kingdom.
authors.forename: J A
authors.initials: JA
authors.lastname: Hall
authors.affiliation: The James Cook University Hospital, South Tees Hospitals NHS Trust, Marton Rd, Middlesbrough TS4 3BW, United Kingdom.
authors.forename: R A
authors.initials: RA
authors.lastname: Wright
authors.affiliation: The James Cook University Hospital, South Tees Hospitals NHS Trust, Marton Rd, Middlesbrough TS4 3BW, United Kingdom.
authors.forename: D F
authors.initials: DF
authors.lastname: Muir
authors.affiliation: The James Cook University Hospital, South Tees Hospitals NHS Trust, Marton Rd, Middlesbrough TS4 3BW, United Kingdom.
authors.forename: A G C
authors.initials: AG
authors.lastname: Sutton
authors.affiliation: The James Cook University Hospital, South Tees Hospitals NHS Trust, Marton Rd, Middlesbrough TS4 3BW, United Kingdom.
authors.forename: N
authors.initials: N
authors.lastname: Swanson
authors.affiliation: The James Cook University Hospital, South Tees Hospitals NHS Trust, Marton Rd, Middlesbrough TS4 3BW, United Kingdom.
authors.forename: J
authors.initials: J
authors.lastname: Carter
authors.affiliation: The James Cook University Hospital, South Tees Hospitals NHS Trust, Marton Rd, Middlesbrough TS4 3BW, United Kingdom.
authors.forename: R
authors.initials: R
authors.lastname: Bilous
authors.affiliation: The James Cook University Hospital, South Tees Hospitals NHS Trust, Marton Rd, Middlesbrough TS4 3BW, United Kingdom.
authors.forename: S
authors.initials: S
authors.lastname: Jones
authors.affiliation: The James Cook University Hospital, South Tees Hospitals NHS Trust, Marton Rd, Middlesbrough TS4 3BW, United Kingdom.
authors.forename: M A
authors.initials: MA
authors.lastname: de Belder
mesh_terms: D054058:Acute Coronary Syndrome / Q000601:surgery*; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage* / Q000627:therapeutic use; D000368:Aged; D000497:Alloys / Q000737:chemistry*; D002858:Chromium Alloys; D023903:Coronary Restenosis / Q000453:epidemiology* / Q000209:etiology / Q000517:prevention & control; D004311:Double-Blind Method; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects*; D011239:Prednisolone / Q000008:administration & dosage* / Q000627:therapeutic use; D011474:Prosthesis Design; D013193:Stainless Steel; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D000497:Alloys; D002858:Chromium Alloys; D013193:Stainless Steel; D011239:Prednisolone
keywords: Angioplasty; Cobalt chromium; Prednisolone; Restenosis; Stainless steel