title: A randomized controlled trial of a paclitaxel-eluting stent versus a similar bare-metal stent in saphenous vein graft lesions the SOS (Stenting of Saphenous Vein Grafts) trial.
abstract: OBJECTIVE
  The aim of this study was to compare the frequency of angiographic restenosis and clinical events between a paclitaxel-eluting stent (PES) and a similar bare-metal stent (BMS) in saphenous vein graft (SVG) lesions.
  
  
  BACKGROUND
  There are conflicting and mostly retrospective data on outcomes after drug-eluting stent implantation in SVGs.
  
  
  METHODS
  Patients requiring SVG lesion stenting were randomized to BMS or PES. The primary study end point was binary in-segment restenosis at 12-month follow-up quantitative coronary angiography. Secondary end points included death, myocardial infarction, ischemia-driven target vessel and lesion revascularization, and target vessel failure.
  
  
  RESULTS
  Eighty patients with 112 lesions in 88 SVGs were randomized to a BMS (39 patients, 43 grafts, 55 lesions) or PES (41 patients, 45 grafts, 57 lesions). Binary angiographic restenosis occurred in 51% of the BMS-treated lesions versus 9% of the PES-treated lesions (relative risk: 0.18; 95% confidence interval [CI]: 0.07 to 0.48, p < 0.0001). During a median follow-up of 1.5 years the PES patients had less target lesion revascularization (28% vs. 5%, hazard ratio: 0.38; 95% CI: 0.15 to 0.74, p = 0.003) and target vessel failure (46% vs. 22%, hazard ratio: 0.65; 95% CI: 0.42 to 0.96, p = 0.03), a trend toward less target vessel revascularization (31% vs. 15%, hazard ratio: 0.66; 95% CI: 0.39 to 1.05, p = 0.08) and myocardial infarction (31% vs. 15%, hazard ratio: 0.67; 95% CI: 0.40 to 1.08, p = 0.10), and similar mortality (5% vs. 12%, hazard ratio: 1.56; 95% CI: 0.72 to 4.11, p = 0.27).
  
  
  CONCLUSIONS
  In SVG lesions, PES are associated with lower rates of angiographic restenosis and target vessel failure than BMS.
authors.affiliation: Veterans Affairs North Texas Healthcare System, Dallas, TX, USA.
authors.forename: Emmanouil S
authors.initials: ES
authors.lastname: Brilakis
authors.forename: Christopher
authors.initials: C
authors.lastname: Lichtenwalter
authors.forename: James A
authors.initials: JA
authors.lastname: de Lemos
authors.forename: Michele
authors.initials: M
authors.lastname: Roesle
authors.forename: Owen
authors.initials: O
authors.lastname: Obel
authors.forename: Donald
authors.initials: D
authors.lastname: Haagen
authors.forename: Bilal
authors.initials: B
authors.lastname: Saeed
authors.forename: Chiranjeevi
authors.initials: C
authors.lastname: Gadiparthi
authors.forename: Joseph K
authors.initials: JK
authors.lastname: Bissett
authors.forename: Rajesh
authors.initials: R
authors.lastname: Sachdeva
authors.forename: Vassilios V
authors.initials: VV
authors.lastname: Voudris
authors.forename: Panagiotis
authors.initials: P
authors.lastname: Karyofillis
authors.forename: Biswajit
authors.initials: B
authors.lastname: Kar
authors.forename: James
authors.initials: J
authors.lastname: Rossen
authors.forename: Panayotis
authors.initials: P
authors.lastname: Fasseas
authors.forename: Peter
authors.initials: P
authors.lastname: Berger
authors.forename: Subhash
authors.initials: S
authors.lastname: Banerjee
mesh_terms: D000368:Aged; D000077144:Clopidogrel; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000601:surgery*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000453:epidemiology / Q000517:prevention & control*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage; D012501:Saphenous Vein / Q000637:transplantation*; D015607:Stents; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives
chemical_list: D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine; D017239:Paclitaxel