title: Direct coronary stent implantation does not reduce the incidence of in-stent restenosis or major adverse cardiac events: six month results of a randomized trial.
abstract: OBJECTIVE
  To compare the long-term angiographic, clinical and economic outcome of direct stenting vs stenting after balloon predilatation.
  
  
  METHODS
  Four hundred patients with coronary stenoses in a single native vessel were randomized to direct stenting vs stenting after predilatation. A major adverse cardiac and cerebral event (MACCE) was defined as death, myocardial infarction, stent thrombosis, target restenosis, repeat target- and non-target vessel-related percutaneous coronary intervention, target lesion revascularization, coronary artery bypass surgery and stroke.
  
  
  RESULTS
  Stents were successfully implanted in 98.3% of patients randomized to direct stenting vs 97.8% randomized to stenting preceded by predilatation. The primary success rate of direct stenting was 88.3%, vs 97.8% for stenting preceded by balloon dilatation (P=0.01). The angiographic follow-up at 6 months included 333 of the 400 patients (83%). The binary in-stent restenosis rate was 23.1% of 163 patients randomized to direct stenting vs 18.8% of 166 patients randomized to balloon predilatation (P=0.32). By 185+/-25 days, MACCE had occurred in 31 of 200 (15.5%) patients randomized to direct stenting, vs 33 of 200 (16.5%) randomized to predilatation (P=0.89). At 6 months, costs associated with the direct stenting strategy (Euros 3222/patient) were similar to those associated with predilatation (Euros 3428/patient, P=0.43). However, procedural costs were significantly lower. It is noteworthy that, on multivariate analysis, a baseline C-reactive protein level >10 mg l(-1)was a predictor of restenosis (odds ratio: 2.10, P=0.025) as well as of MACCE (odds ratio: 1.94, P=0.045).
  
  
  CONCLUSIONS
  Compared to stenting preceded by balloon predilatation, direct stenting was associated with similar 6-month restenosis and MACCE rates. Procedural, but not overall 6-month costs, were reduced by direct stenting. An increased baseline CRP level was an independent predictor of adverse long-term outcome after coronary stent implantation.
authors.affiliation: Amsterdam Department of Interventional Cardiology, OLVG-Hospital, 1(e) Oosterparkstraat 279,1090 HM, Amsterdam, The Netherlands. a.j.j.ijsselmuiden@olvg.nl
authors.forename: A J J
authors.initials: AJ
authors.lastname: IJsselmuiden
authors.forename: P W
authors.initials: PW
authors.lastname: Serruys
authors.forename: A
authors.initials: A
authors.lastname: Scholte
authors.forename: F
authors.initials: F
authors.lastname: Kiemeneij
authors.forename: T
authors.initials: T
authors.lastname: Slagboom
authors.forename: L R
authors.initials: LR
authors.lastname: vd Wieken
authors.forename: G J
authors.initials: GJ
authors.lastname: Tangelder
authors.forename: G J
authors.initials: GJ
authors.lastname: Laarman
mesh_terms: D000787:Angina Pectoris / Q000191:economics / Q000628:therapy; D002404:Catheterization / Q000191:economics / Q000379:methods; D023903:Coronary Restenosis / Q000191:economics / Q000517:prevention & control*; D023921:Coronary Stenosis / Q000191:economics / Q000628:therapy*; D003362:Cost-Benefit Analysis; D004868:Equipment Failure; D005260:Female; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009203:Myocardial Infarction / Q000191:economics / Q000517:prevention & control; D015607:Stents / Q000191:economics; D020521:Stroke / Q000191:economics / Q000209:etiology / Q000628:therapy; D016896:Treatment Outcome