title: A prospective, randomized trial of intravascular-ultrasound guided compared to angiography guided stent implantation in complex coronary lesions: the AVIO trial.
abstract: BACKGROUND
  No randomized studies have thus far evaluated intravascular ultrasound (IVUS) guidance in the drug-eluting stent (DES) era. The aim was to evaluate if IVUS optimized DES implantation was superior to angiographic guidance alone in complex lesions.
  
  
  METHODS
  Randomized, multicentre, international, open label, investigator-driven study evaluating IVUS vs angiographically guided DES implantation in patients with complex lesions (defined as bifurcations, long lesions, chronic total occlusions or small vessels). Primary study endpoint was post-procedure in lesion minimal lumen diameter. Secondary end points were combined major adverse cardiac events (MACE), target lesion revascularization, target vessel revascularization, myocardial infarction (MI), and stent thrombosis at 1, 6, 9, 12, and 24 months.
  
  
  RESULTS
  The study included 284 patients. No significant differences were observed in baseline characteristics. The primary study end point showed a statistically significant difference in favor of the IVUS group (2.70 mm ± 0.46 mm vs. 2.51 ± 0.46 mm; P = .0002). During hospitalization, no patient died, had repeated revascularization, or a Q-wave MI. No difference was observed in the occurrence of non-Q wave MI (6.3% in IVUS vs. 7.0% in angio-guided group). At 24-months clinical follow-up, no differences were still observed in cumulative MACE (16.9%vs. 23.2 %), cardiac death (0%vs. 1.4%), MI (7.0%vs. 8.5%), target lesion revascularization (9.2% vs. 11.9%) or target vessel revascularization (9.8% vs. 15.5%), respectively in the IVUS vs. angio-guided groups. In total, only one definite subacute stent thrombosis occurred in the IVUS group.
  
  
  CONCLUSIONS
  A benefit of IVUS optimized DES implantation was observed in complex lesions in the post-procedure minimal lumen diameter. No statistically significant difference was found in MACE up to 24 months.
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute, Via Olgettina 60, Milan, Italy.
authors.forename: Alaide
authors.initials: A
authors.lastname: Chieffo
authors.forename: Azeem
authors.initials: A
authors.lastname: Latib
authors.forename: Christophe
authors.initials: C
authors.lastname: Caussin
authors.forename: Patrizia
authors.initials: P
authors.lastname: Presbitero
authors.forename: Stefano
authors.initials: S
authors.lastname: Galli
authors.forename: Alberto
authors.initials: A
authors.lastname: Menozzi
authors.forename: Ferdinando
authors.initials: F
authors.lastname: Varbella
authors.forename: Fina
authors.initials: F
authors.lastname: Mauri
authors.forename: Marco
authors.initials: M
authors.lastname: Valgimigli
authors.forename: Chourmouzios
authors.initials: C
authors.lastname: Arampatzis
authors.forename: Manuel
authors.initials: M
authors.lastname: Sabate
authors.forename: Andrejs
authors.initials: A
authors.lastname: Erglis
authors.forename: Bernhard
authors.initials: B
authors.lastname: Reimers
authors.forename: Flavio
authors.initials: F
authors.lastname: Airoldi
authors.forename: Mika
authors.initials: M
authors.lastname: Laine
authors.forename: Ramon Lopez
authors.initials: RL
authors.lastname: Palop
authors.forename: Ghada
authors.initials: G
authors.lastname: Mikhail
authors.forename: Philip
authors.initials: P
authors.lastname: Maccarthy
authors.forename: Francesco
authors.initials: F
authors.lastname: Romeo
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
mesh_terms: D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D017023:Coronary Angiography / Q000379:methods*; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging* / Q000401:mortality; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction; D011446:Prospective Studies; D018570:Risk Assessment; D016019:Survival Analysis; D013927:Thrombosis; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional / Q000379:methods*