title: Maintenance of long-term clinical benefit with sirolimus-eluting coronary stents: three-year results of the RAVEL trial.
abstract: BACKGROUND
  The use of sirolimus-eluting coronary stents has been associated with a nearly complete elimination of restenosis at 6 months and with a very low 1-year incidence of major adverse cardiac events (MACE). This analysis examined whether these beneficial effects persist over the longer term.
  
  
  RESULTS
  This multicenter trial randomly assigned 238 patients to revascularization of single, de novo, native coronary artery lesions with sirolimus-eluting versus conventional bare-metal stents. Survival free from target lesion revascularization (TLR), target vessel failure (TVF), and MACE up to 3 years of follow-up was compared between the 2 treatment groups. Complete data sets were available in 94.2% of patients treated with sirolimus-eluting stents and in 94.1% of patients randomized to the control group. The cumulative 1-, 2-, and 3-year event-free survival rates were 99.2%, 96.5%, and 93.7% for TLR and 95.8%, 92.3%, and 87.9% for TVF, respectively, in the sirolimus-eluting stent group, versus 75.9%, 75.9%, and 75.0% for TLR and 71.2%, 69.4%, and 67.3% for TVF in the control group (P<0.001 for both comparisons at 3 years). Rates of MACE at 3 years were 15.8% in patients randomly assigned to sirolimus-eluting stents versus 33.1% in patients assigned to bare-metal stents (P=0.002). One patient treated with a sirolimus-eluting stent died of a cardiac cause between 12 and 36 months.
  
  
  CONCLUSIONS
  Treatment of de novo coronary stenosis with sirolimus-eluting stents was associated with a sustained clinical benefit and very low rates of TLR and of other MACE up to 3 years after device implantation.
authors.affiliation: Clinique Pasteur, 45, Avenue du Lombez, 31300 Toulouse, France. fajadet@interv-cardiol-toul.com
authors.forename: Jean
authors.initials: J
authors.lastname: Fajadet
authors.forename: Marie-Claude
authors.initials: MC
authors.lastname: Morice
authors.forename: Christoph
authors.initials: C
authors.lastname: Bode
authors.forename: Paul
authors.initials: P
authors.lastname: Barragan
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.forename: William
authors.initials: W
authors.lastname: Wijns
authors.forename: Constantino R
authors.initials: CR
authors.lastname: Constantini
authors.forename: Jean-Léon
authors.initials: JL
authors.lastname: Guermonprez
authors.forename: Hélène
authors.initials: H
authors.lastname: Eltchaninoff
authors.forename: Didier
authors.initials: D
authors.lastname: Blanchard
authors.forename: Antonio
authors.initials: A
authors.lastname: Bartorelli
authors.forename: Gert-Jan
authors.initials: GJ
authors.lastname: Laarman
authors.forename: MarcoAntonio
authors.initials: M
authors.lastname: Perin
authors.forename: J Eduardo
authors.initials: JE
authors.lastname: Sousa
authors.forename: Gerhard
authors.initials: G
authors.lastname: Schuler
authors.forename: Ferenc
authors.initials: F
authors.lastname: Molnar
authors.forename: Giulio
authors.initials: G
authors.lastname: Guagliumi
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
authors.forename: Ernesto
authors.initials: E
authors.lastname: Ban Hayashi
authors.forename: Egon
authors.initials: E
authors.lastname: Wülfert
mesh_terms: D023903:Coronary Restenosis / Q000473:pathology; D023921:Coronary Stenosis / Q000601:surgery*; D003331:Coronary Vessels / Q000473:pathology*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009204:Myocardial Revascularization; D020123:Sirolimus / Q000378:metabolism*; D015607:Stents; D013995:Time
chemical_list: D020123:Sirolimus