title: Comparison of everolimus-eluting and paclitaxel-eluting coronary stents in patients undergoing multilesion and multivessel intervention: the SPIRIT III (A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) and SPIRIT IV (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) randomized trials.
abstract: OBJECTIVE
  We evaluated outcomes following XIENCE V everolimus-eluting stent (EES) compared with the Taxus Express(2) paclitaxel-eluting stent (PES) in patients undergoing multilesion and multivessel intervention.
  
  
  BACKGROUND
  The optimal revascularization strategy for patients with multivessel disease is unknown.
  
  
  METHODS
  The SPIRIT III (A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) (n = 1,002) and SPIRIT IV (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) (n = 3,690) trials enrolled patients with de novo lesions ≤ 28 mm in length and reference vessel diameter of 2.5 to 3.75 mm. The SPIRIT III trial enrolled patients with a single lesion in 1 or 2 coronary arteries, and the SPIRIT IV trial enrolled patients with up to 2 lesions in 3 different vessels (maximum 2 lesions per vessel). In both trials, patients were randomized 2:1 to EES vs. PES. Clinical outcomes to 1 year were analyzed in patients with single (n = 3,823) versus multiple (n = 765) treated vessels, and in those with single (n = 3,536) versus multiple (n = 1,052) treated lesions.
  
  
  RESULTS
  Among patients with multivessel disease, EES compared with PES resulted in reduced rates of target vessel myocardial infarction (2.2% vs. 6.1%, p = 0.007) and ischemia-driven target lesion revascularization (4.2% vs. 8.0%, p = 0.04). Among patients undergoing multilesion stenting, EES compared with PES resulted in reduced rates of target vessel myocardial infarction (2.1% vs. 5.4%, p = 0.008) and ischemia-driven target lesion revascularization (3.7% vs. 7.4%, p = 0.01). The absolute benefits of EES versus PES in patients undergoing multivessel or multilesion intervention were greater than in those undergoing single-lesion, single-vessel intervention.
  
  
  CONCLUSIONS
  The EES compared with PES provided significant improvements in clinical safety and efficacy outcomes. The absolute benefit provided by EES versus PES appears to be proportional to the complexity of coronary disease.
authors.affiliation: Christ Hospital Heart and Vascular Center/The Lindner Research Center, 2123 Auburn Avenue, Cincinnati, OH 45129, USA. lindner@thechristhospital.com
authors.forename: Dean J
authors.initials: DJ
authors.lastname: Kereiakes
authors.forename: Krishnankutty
authors.initials: K
authors.lastname: Sudhir
authors.forename: James B
authors.initials: JB
authors.lastname: Hermiller
authors.forename: Paul C
authors.initials: PC
authors.lastname: Gordon
authors.forename: Joanne
authors.initials: J
authors.lastname: Ferguson
authors.forename: Manejeh
authors.initials: M
authors.lastname: Yaqub
authors.forename: Poornima
authors.initials: P
authors.lastname: Sood
authors.forename: Xiaolu
authors.initials: X
authors.lastname: Su
authors.forename: Steven
authors.initials: S
authors.lastname: Yakubov
authors.forename: Alexandra J
authors.initials: AJ
authors.lastname: Lansky
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
mesh_terms: D015906:Angioplasty, Balloon, Coronary; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000627:therapeutic use*; D001026:Coronary Artery Bypass; D003324:Coronary Artery Disease / Q000188:drug therapy* / Q000401:mortality / Q000628:therapy; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D013997:Time Factors; D014481:United States
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D007166:Immunosuppressive Agents; D000068338:Everolimus; D017239:Paclitaxel; D020123:Sirolimus