title: 5-year clinical outcomes of the ARTS II (Arterial Revascularization Therapies Study II) of the sirolimus-eluting stent in the treatment of patients with multivessel de novo coronary artery lesions.
abstract: OBJECTIVE
  The purpose of this study is to compare the 5-year clinical outcomes, safety, and efficacy of sirolimus-eluting stents (SES) in the ARTS II (Arterial Revascularization Therapies Study II) with the outcomes of coronary artery bypass graft (CABG) and bare-metal stenting (BMS) from the ARTS I.
  
  
  BACKGROUND
  The long-term outcomes after SES implantation in patients with multivessel disease remains to be established.
  
  
  METHODS
  The ARTS I was a randomized trial of 1,205 patients with multivessel disease comparing CABG and BMS. The ARTS II study was a nonrandomized trial with the Cypher sirolimus-eluting stent (Cordis, a Johnson & Johnson Company, Warren, New Jersey), applying the same inclusion and exclusion criteria, end points, and protocol definitions. The ARTS II trial enrolled 607 patients, with an attempt to enroll at least one-third of patients with 3-vessel disease.
  
  
  RESULTS
  At 5-year, the death/stroke/myocardial infarction event-free survival rate was 87.1% in ARTS II SES, versus 86.0% (p = 0.1) and 81.9% (p = 0.007) in ARTS I CABG and BMS cohorts, respectively. The 5-year major adverse cardiac and cerebrovascular event (MACCE) rate in ARTS II (27.5%) was significantly higher than ARTS I CABG (21.1%, p = 0.02), and lower than in ARTS I BMS (41.5%, p < 0.001). The cumulative incidence of definite stent thrombosis was 3.8%. Thirty-two percent (56 of 176) of major adverse cardiac events (MACE) at 5 years were related to possible, probable, or definite stent thrombosis.
  
  
  CONCLUSIONS
  At 5 years, SES had a safety record comparable to CABG and superior to BMS, and a MACCE rate that was higher than in patients treated with CABG, and lower than in those treated with BMS. Approximately one-third of the events seen with SES could be prevented through the elimination of early, late, and very late stent thrombosis.
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands. p.w.j.c.serruys@erasmusmc.nl
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Onuma
authors.forename: Scot
authors.initials: S
authors.lastname: Garg
authors.forename: Pascal
authors.initials: P
authors.lastname: Vranckx
authors.forename: Bernard
authors.initials: B
authors.lastname: De Bruyne
authors.forename: Marie-Claude
authors.initials: MC
authors.lastname: Morice
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
authors.forename: Carlos
authors.initials: C
authors.lastname: Macaya
authors.forename: Gert
authors.initials: G
authors.lastname: Richardt
authors.forename: Jean
authors.initials: J
authors.lastname: Fajadet
authors.forename: Christian
authors.initials: C
authors.lastname: Hamm
authors.forename: Monique
authors.initials: M
authors.lastname: Schuijer
authors.forename: Tessa
authors.initials: T
authors.lastname: Rademaker
authors.forename: Kristel
authors.initials: K
authors.lastname: Wittebols
authors.forename: Hans Peter
authors.initials: HP
authors.lastname: Stoll
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D001026:Coronary Artery Bypass; D003324:Coronary Artery Disease / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D020123:Sirolimus / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D020123:Sirolimus