title: Intravascular ultrasound-guided balloon angioplasty compared with stent: immediate and 6-month results of the multicenter, randomized Balloon Equivalent to Stent Study (BEST).
abstract: BACKGROUND
  Balloon angioplasty guided by intravascular ultrasound (IVUS) makes it possible to choose the balloon size according to the true vessel diameter and to detect suboptimal results requiring subsequent stent implantation. The Balloon Equivalent to STent (BEST) study aimed to assess whether this strategy would give the same results as systematic stenting.
  
  
  RESULTS
  A total of 132 of 254 patients were randomized to IVUS-guided percutaneous transluminal coronary angioplasty (aggressive PTCA), and 122 were randomized to stenting (stent group). We hypothesized that a difference of <8% in the 6-month angiographic restenosis rate (primary end point) could be considered noninferior. The aggressive PTCA procedure was longer and had a greater use of contrast medium than stenting. In the aggressive PTCA group, crossover to stent was needed in 58 patients (44%). At 6 months, 20 of 119 patients (16.8+/-6.7%) in the aggressive PTCA group and 21 of 116 patients (18.1+/-7.0%) in the stent group had restenosis. The difference was -1.3%, with an upper limit of 95% confidence interval of 7.1% (ie, less than the noninferiority boundary). The in-stent restenosis rate was higher in the stent group (15.5% versus 5%; P=0.02). The differences in minimum lumen diameter, lumen cross-section area, and 1-year event rate were not significant.
  
  
  CONCLUSIONS
  A strategy of IVUS-guided angioplasty with provisional stenting is feasible and safe. At the cost of a more complex procedure, it reduces the stent rate by half, with similar 6-month angiographic IVUS and clinical outcome compared with stent implantation.
authors.affiliation: University Hospital Jean-Minjoz, Besançon, France. francois.schiele@ufc-chu.univ-fcomte.fr
authors.forename: François
authors.initials: F
authors.lastname: Schiele
authors.forename: Nicolas
authors.initials: N
authors.lastname: Meneveau
authors.forename: Martine
authors.initials: M
authors.lastname: Gilard
authors.forename: Jacques
authors.initials: J
authors.lastname: Boschat
authors.forename: Philippe
authors.initials: P
authors.lastname: Commeau
authors.forename: Liu Pin
authors.initials: LP
authors.lastname: Ming
authors.forename: Pradip
authors.initials: P
authors.lastname: Sewoke
authors.forename: Marie-France
authors.initials: MF
authors.lastname: Seronde
authors.forename: Mariette
authors.initials: M
authors.lastname: Mercier
authors.forename: Sanjiv
authors.initials: S
authors.lastname: Gupta
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Bassand
mesh_terms: D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000379:methods; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects; D003287:Contrast Media / Q000008:administration & dosage; D023903:Coronary Restenosis / Q000209:etiology / Q000517:prevention & control; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D018401:Sample Size; D015607:Stents / Q000009:adverse effects; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional; D014654:Vascular Patency
chemical_list: D003287:Contrast Media