title: Angiographic, intravascular ultrasound, and fractional flow reserve evaluation of direct stenting vs. conventional stenting using BeStent2 in a multicentre randomized trial.
abstract: OBJECTIVE
  Direct stenting (DS) may not be as safe and effective as conventional stenting. The objective was to demonstrate equivalence of post-procedural mean luminal diameter (MLD) by angiography after BeStent2 placement between DS and pre-dilatation (PD) strategy.
  
  
  RESULTS
  Two hundred and two patients with a single de novo lesion (diameter >/=3.0 mm and length </=13 mm) were randomized to DS (n=101) vs. PD. Stent deployment was guided by on-line quantitative coronary angiography (QCA). A second randomization assigned half of the patients to intravascular ultrasound (IVUS) and fractional flow reserve (FFR) assessment. QCA was repeated at 6 months. Baseline characteristics were similar. Crossover to PD was necessary in seven DS patients. Stent deployment was successful in 97% (DS) and 98% (PD). The post-procedural MLD was 2.79+/-0.45 mm (DS) and 2.76+/-0.40 mm (PD). The null-hypothesis of non-equivalence could be rejected (95% one-sided; P=0.0003). The minimum stent area (IVUS) was 7.89+/-1.75 mm(2) (DS) and 8.07+/-2.37 mm(2) (PD; P=0.69), with an FFR of 0.92+/-0.07 and 0.92+/-0.05, respectively (P=0.97). Major adverse cardiac event rates at 6 months were 9% (DS) and 11% (PD; P=0.93). Target lesion re-angioplasty was 6% (DS) and 5% (PD; P=0.77). The in-stent restenosis rate by QCA was 7.4% (DS) and 6.8% (PD; P=0.87).
  
  
  CONCLUSIONS
  DS with BeStent2 is equivalent to PD. Both strategies resulted in a low angiographic restenosis rate.
authors.affiliation: Cardiovascular Centre, OLV Hospital, Moorselbaan 164, 9300 Aalst, Belgium. william.wijns@olvz-aalst.be
authors.forename: William
authors.initials: W
authors.lastname: Wijns
authors.forename: Stefan
authors.initials: S
authors.lastname: Verheye
authors.forename: Ganesh
authors.initials: G
authors.lastname: Manoharan
authors.forename: Gerald S
authors.initials: GS
authors.lastname: Werner
authors.forename: Eberhard
authors.initials: E
authors.lastname: Grube
authors.forename: Bernard
authors.initials: B
authors.lastname: De Bruyne
authors.forename: Jacques
authors.initials: J
authors.lastname: Koolen
authors.forename: Christian W
authors.initials: CW
authors.lastname: Hamm
authors.forename: Alfonso
authors.initials: A
authors.lastname: Medina
authors.forename: Jan Willem
authors.initials: JW
authors.lastname: Bech
authors.forename: Pim J
authors.initials: PJ
authors.lastname: De Feyter
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000379:methods; D001783:Blood Flow Velocity; D017023:Coronary Angiography; D003326:Coronary Circulation; D023903:Coronary Restenosis / Q000209:etiology; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000473:pathology / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016037:Single-Blind Method; D015607:Stents; D018084:Ultrasonography, Interventional