title: Safety, efficacy and costs associated with direct coronary stenting compared with stenting after predilatation: A randomised controlled trial.
abstract: OBJECTIVE
  Comparison of the in-hospital success rates, procedural costs and short-term clinical outcomes of direct stenting versus stenting after balloon predilatation.
  
  
  METHODS
  Altogether, 400 patients with angina pectoris and/or myocardial ischaemia due to coronary stenoses in a single native vessel were randomised to either direct stenting or stenting after predilatation. Baseline characteristics were evenly distributed between the two groups.
  
  
  RESULTS
  Procedural success rates were similar (96.0% direct stenting group vs. 94.5% predilatation) as well as final successful stent implantation (98.3 vs. 97.8%), while the primary success rate of direct stenting alone was 88.3%, p=0.01. In multivariate analysis, angiographic lesion calcification was an independent predictor of unsuccessful direct stenting (odds ratio 7.1, 95% confidence interval 2.8-18.2, p<0.0001). Rates of troponin I rises >0.15 μg/l, used as a measure of distal embolisation, were similar in both groups (17.8 vs. 17.1%). Rates of major adverse cardiac events at 30 days were 4.5% in the direct stenting group versus 5.5% in the predilated group (ns). Direct stenting was associated with savings in fluoroscopy time, and angiographic contrast agent use, and a reduction in utilisation of angioplasty balloons (0.4 vs. 1.17 balloons per patient, p<0.001). Mean per patient procedural costs associated with direct stenting versus predilatation were €2545±914 versus €2763±842 (p=0.01), despite the implantation of more stents in the directly stented group.
  
  
  CONCLUSIONS
  Compared with a strategy of stenting preceded by balloon predilatation, direct stenting was equally safe and effective, with similar in-hospital and 30-day clinical outcomes, and modest procedural cost-savings. A calcified lesion predicted unsuccessful direct stenting.
authors.forename: A
authors.initials: A
authors.lastname: IJsselmuiden
authors.forename: P W
authors.initials: PW
authors.lastname: Serruys
authors.forename: G J
authors.initials: GJ
authors.lastname: Tangelder
authors.forename: T
authors.initials: T
authors.lastname: Slagboom
authors.forename: R
authors.initials: R
authors.lastname: van der Wieken
authors.forename: F
authors.initials: F
authors.lastname: Kiemeneij
authors.forename: G J
authors.initials: GJ
authors.lastname: Laarman
keywords: angioplasty; coronary artery disease; coronary stent; direct stenting; predilatation