title: Direct stenting with the Bx VELOCITY balloon-expandable stent mounted on the Raptor rapid exchange delivery system versus predilatation in a European randomized Trial: the VELVET trial.
abstract: OBJECTIVE
  This study examined the six-month angiographic results of direct coronary stenting, and compared the nine-month safety, efficacy and cost of this strategy versus stenting after balloon predilatation.
  
  
  METHODS
  In phase I of VELVET, 122 patients (mean age = 62.3 +/- 10.1 years, 77% male, 11% with diabetes) with angina pectoris or myocardial ischemia resulting from a single de novo 51% to 95% coronary stenosis underwent direct stenting. The endpoints of phase I included angiographic findings and rates of major adverse cardiac events up to six months of follow-up. In phase II, 401 patients (mean age = 61.3 +/- 10.8 years, 79% male, 16% with diabetes) with angina pectoris or documented myocardial ischemia resulting from single or multiple, de novo or restenotic, coronary lesions were randomized between direct stenting and stenting after predilatation. The immediate angiographic results, and clinical outcomes and costs associated with the two treatment strategies up to nine months of follow-up were compared.
  
  
  RESULTS
  In phase I the mean diameter stenosis immediately before and after the procedure, and at six months was 61.7+/-9.4%, 13.5+/-6.3%, and 33.6+/-16.2%, respectively. The six-month binary restenosis rate was 11%. The overall rate of major adverse cardiac events, including two non-cardiac deaths, was 9.8%. In phase II, the success rates of the intended delivery strategies were 87.9% and 97.9% for direct stenting and predilatation, respectively (p < 0.001), while the procedural success rates were similar (93.9% vs 96.5%). Over a follow-up period of nine months, major adverse cardiac events rates were 12.0% and 10.9% in patients randomized to direct stenting and predilatation, respectively (non-significant). Analyses of the costs incurred up to nine months in each treatment group revealed a mean saving of e362 per patient in favor of the direct stenting strategy (non-significant).
  
  
  CONCLUSIONS
  Compared with a strategy of stenting preceded by balloon dilatation, direct stenting was associated with an equivalent procedural success rate, equivalent clinical results up to nine months of follow-up, and a reduction in procedural and in-hospital costs (p < 0.0001 and p < 0.001, respectively), that was no longer significant after nine months.
authors.affiliation: Ac. ZH Rotterdam Dijkzigt, Rotterdam, The Netherlands Cordis Corporation, Waterloo, Belgium & Warren, NJ, USA.
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.forename: Sander
authors.initials: S
authors.lastname: IJsselmuiden
authors.forename: Ben van
authors.initials: Bv
authors.lastname: Hout
authors.forename: Paul
authors.initials: P
authors.lastname: Vermeersch
authors.forename: Ezio
authors.initials: E
authors.lastname: Bramucci
authors.forename: Victor
authors.initials: V
authors.lastname: Legrand
authors.forename: Michael
authors.initials: M
authors.lastname: Pieper
authors.forename: David
authors.initials: D
authors.lastname: Antoniucci
authors.forename: Ricardo Seabra
authors.initials: RS
authors.lastname: Gomes
authors.forename: Carlos
authors.initials: C
authors.lastname: Macaya
authors.forename: Peter
authors.initials: P
authors.lastname: Boekstegers
authors.forename: Wietze
authors.initials: W
authors.lastname: Lindeboom
mesh_terms: D000787:Angina Pectoris / Q000401:mortality / Q000628:therapy*; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000379:methods*; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000401:mortality / Q000517:prevention & control; D003365:Costs and Cost Analysis; D023381:Endpoint Determination; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D012449:Safety; D015607:Stents; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D005343:Fibrinolytic Agents; D010975:Platelet Aggregation Inhibitors