title: Drug-eluting versus bare-metal stents in saphenous vein graft lesions (ISAR-CABG): a randomised controlled superiority trial.
abstract: BACKGROUND
  Comparative assessment of clinical outcomes after use of drug-eluting stents versus bare-metal stents for treatment of aortocoronary saphenous vein graft lesions has not been undertaken in large randomised trials. We aimed to undertake a comparison in a randomised trial powered for clinical endpoints.
  
  
  METHODS
  In this randomised superiority trial, patients with de-novo saphenous vein graft lesions were assigned by computer-generated sequence (1:1:1:3) to receive either drug-eluting stents (one of three types: permanent-polymer paclitaxel-eluting stents, permanent-polymer sirolimus-eluting stents, or biodegradable-polymer sirolimus-eluting stents) or bare-metal stents. Randomisation took place immediately after crossing of the lesion with a guidewire, and was stratified for each participating centre. Investigators assessing data were masked to treatment allocation; patients were not masked to allocation. The primary endpoint was the combined incidence of death, myocardial infarction, and target lesion revascularisation at 1 year. Analysis was by intention to treat. This trial is registered at ClinicalTrials.gov, number NCT00611910.
  
  
  RESULTS
  610 patients were allocated to treatment groups (303 drug-eluting stent, 307 bare-metal stent). Drug-eluting stents reduced the incidence of the primary endpoint compared with bare-metal stents (44 [15%] vs 66 [22%] patients; hazard ratio [HR] 0.64, 95% CI 0.44-0.94; p=0.02). Target lesion revascularisation rate was reduced by drug-eluting stents (19 [7%] vs 37 [13%] patients; HR 0.49, 95% CI 0.28-0.86; p=0.01). No significant differences were seen between drug-eluting stents and bare-metal stents regarding all-cause mortality (15 [5%] vs 14 [5%] patients; HR 1.08, 95% CI 0.52-2.24; p=0.83), myocardial infarction (12 [4%] vs 18 [6%]; HR 0.66, 95% CI 0.32-1.37; p=0.27), or definite or probable stent thrombosis (2 [1%] in both groups; HR 1.00, 95% CI 0.14-7.10; p=0.99).
  
  
  CONCLUSIONS
  In patients undergoing percutaneous coronary intervention for de-novo saphenous vein graft lesions, drug-eluting stents are the preferred treatment option because they reduce the risk of adverse events compared with bare-metal stents.
  
  
  BACKGROUND
  Deutsches Herzzentrum.
authors.affiliation: Deutsches Herzzentrum, Technische Universität, Munich, Germany. mehilli@dhm.mhn.de
authors.forename: Julinda
authors.initials: J
authors.lastname: Mehilli
authors.forename: Jürgen
authors.initials: J
authors.lastname: Pache
authors.forename: Mohamed
authors.initials: M
authors.lastname: Abdel-Wahab
authors.forename: Stefanie
authors.initials: S
authors.lastname: Schulz
authors.forename: Robert A
authors.initials: RA
authors.lastname: Byrne
authors.forename: Klaus
authors.initials: K
authors.lastname: Tiroch
authors.forename: Jörg
authors.initials: J
authors.lastname: Hausleiter
authors.forename: Melchior
authors.initials: M
authors.lastname: Seyfarth
authors.forename: Ilka
authors.initials: I
authors.lastname: Ott
authors.forename: Tareq
authors.initials: T
authors.lastname: Ibrahim
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Fusaro
authors.forename: Karl-Ludwig
authors.initials: KL
authors.lastname: Laugwitz
authors.forename: Steffen
authors.initials: S
authors.lastname: Massberg
authors.forename: Franz-Josef
authors.initials: FJ
authors.lastname: Neumann
authors.forename: Gert
authors.initials: G
authors.lastname: Richardt
authors.forename: Albert
authors.initials: A
authors.lastname: Schömig
authors.forename: Adnan
authors.initials: A
authors.lastname: Kastrati
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D001026:Coronary Artery Bypass; D054855:Drug-Eluting Stents / Q000009:adverse effects; D005260:Female; D006083:Graft Occlusion, Vascular / Q000601:surgery*; D006801:Humans; D008297:Male; D008670:Metals; D017239:Paclitaxel; D011108:Polymers; D012501:Saphenous Vein / Q000473:pathology / Q000601:surgery* / Q000637:transplantation; D020123:Sirolimus; D015607:Stents / Q000009:adverse effects
chemical_list: D008670:Metals; D011108:Polymers; D017239:Paclitaxel; D020123:Sirolimus