title: Randomized comparison of coronary stent implantation under ultrasound or angiographic guidance to reduce stent restenosis (OPTICUS Study).
abstract: BACKGROUND
  Observational studies in selected patients have shown remarkably low restenosis rates after ultrasound-guided stent implantation. However, it is unknown whether this implantation strategy improves long-term angiographic and clinical outcome in routine clinical practice. Methods and Results-- A total of 550 patients with a symptomatic coronary lesion or silent ischemia were randomly assigned to either ultrasound-guided or angiography-guided implantation of </=2 tubular stents. The primary end points were angiographic dichotomous restenosis rate, minimal lumen diameter, and percent diameter stenosis after 6 months as determined by quantitative coronary angiography. Secondary end points were the occurrence rates of major adverse cardiac events (death, myocardial infarction, coronary bypass surgery, and repeat percutaneous intervention) after 6 and 12 months of follow-up. At 6 months, repeat angiography revealed no significant differences between the groups with ultrasound- or angiography-guided stent implantation with respect to dichotomous restenosis rate (24.5% versus 22.8%, P=0.68), minimal lumen diameter (1.95+/-0.72 mm versus 1.91+/-0.68 mm, P=0.52), and percent diameter stenosis (34.8+/-20.6% versus 36.8+/-19.6%, P=0.29), respectively. At 12 months, neither major adverse cardiac events (relative risk, 1.07; 95% CI 0.75 to 1.52; P=0.71) nor repeat percutaneous interventions (relative risk 1.04; 95% CI 0.64 to 1.67; P=0.87) were reduced in the ultrasound-guided group.
  
  
  CONCLUSIONS
  This study does not support the routine use of ultrasound guidance for coronary stenting. Angiography-guided optimization of tubular stents can be performed with comparable angiographic and clinical long-term results.
authors.affiliation: Universitätsklinikum Innenstadt, München, Germany. mudra.kh-neuperlach@extern.lrz-muenchen.de
authors.forename: H
authors.initials: H
authors.lastname: Mudra
authors.forename: C
authors.initials: C
authors.lastname: di Mario
authors.forename: P
authors.initials: P
authors.lastname: de Jaegere
authors.forename: H R
authors.initials: HR
authors.lastname: Figulla
authors.forename: C
authors.initials: C
authors.lastname: Macaya
authors.forename: R
authors.initials: R
authors.lastname: Zahn
authors.forename: B
authors.initials: B
authors.lastname: Wennerblom
authors.forename: W
authors.initials: W
authors.lastname: Rutsch
authors.forename: V
authors.initials: V
authors.lastname: Voudris
authors.forename: E
authors.initials: E
authors.lastname: Regar
authors.forename: K H
authors.initials: KH
authors.lastname: Henneke
authors.forename: V
authors.initials: V
authors.lastname: Schächinger
authors.forename: A
authors.initials: A
authors.lastname: Zeiher
mesh_terms: D019917:Blood Vessel Prosthesis Implantation / Q000295:instrumentation / Q000379:methods*; D017023:Coronary Angiography; D003327:Coronary Disease / Q000601:surgery*; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012306:Risk; D015607:Stents; D016896:Treatment Outcome; D014463:Ultrasonography; D014654:Vascular Patency