title: Clinical follow-up 3 years after everolimus- and paclitaxel-eluting stents: a pooled analysis from the SPIRIT II (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) and 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) randomized trials.
abstract: OBJECTIVE
  The purpose of this study was to investigate long-term 3-year clinical outcomes of an everolimus-eluting stent (EES) versus a paclitaxel-eluting stent (PES).
  
  
  BACKGROUND
  Compared with PES, EES reduced target vessel failure and major adverse cardiac events at 2 years. Whether the benefits of EES are sustained at 3 years has not been reported.
  
  
  METHODS
  In the SPIRIT II (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) and 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) trials, 1,302 patients were randomly assigned to EES (n = 892) or PES (n = 410). We report the 3-year clinical follow-up of this patient-level pooled analysis.
  
  
  RESULTS
  At 3 years, EES compared with PES resulted in a significant reduction in myocardial infarction (3.8% vs. 6.7%; relative risk [RR]: 0.56; 95% confidence interval [CI]: 0.34 to 0.94; p = 0.04), and target lesion revascularization (6.8% vs. 12.7%; RR: 0.53; 95% CI: 0.37 to 0.77; p = 0.001). Everolimus-eluting stents resulted in a significant reduction in target vessel failure (13.7% vs. 19.5%; RR: 0.70; 95% CI: 0.54 to 0.92; p = 0.01), and major adverse cardiac events (9.1% vs. 16.3%; RR: 0.56; 95% CI: 0.41 to 0.76; p = 0.0004). The cumulative rates of Academic Research Consortium-defined definite or probable stent thrombosis were 1.2% in EES patients and 1.9% in PES patients (RR: 0.64; 95% CI: 0.25 to 1.68; p = 0.43).
  
  
  CONCLUSIONS
  In this patient-level pooled analysis, EES compared with PES resulted in a significant and persistent reduction in target vessel failure and major adverse cardiac events at 3 years due to fewer myocardial infarction and ischemic target lesion revascularization events, which is consistent with superior safety and efficacy of the EES platform.
authors.affiliation: Columbia University Medical Center and the Cardiovascular Research Foundation, 111 East 59th Street, New York, NY 10022, USA.
authors.forename: Adriano
authors.initials: A
authors.lastname: Caixeta
authors.forename: Alexandra J
authors.initials: AJ
authors.lastname: Lansky
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.forename: James B
authors.initials: JB
authors.lastname: Hermiller
authors.forename: Peter
authors.initials: P
authors.lastname: Ruygrok
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Onuma
authors.forename: Paul
authors.initials: P
authors.lastname: Gordon
authors.forename: Manejeh
authors.initials: M
authors.lastname: Yaqub
authors.forename: Karine
authors.initials: K
authors.lastname: Miquel-Hebert
authors.forename: Susan
authors.initials: S
authors.lastname: Veldhof
authors.forename: Poornima
authors.initials: P
authors.lastname: Sood
authors.forename: Xiaolu
authors.initials: X
authors.lastname: Su
authors.forename: Lalitha
authors.initials: L
authors.lastname: Jonnavithula
authors.forename: Krishnankutty
authors.initials: K
authors.lastname: Sudhir
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*; D001241:Aspirin / Q000627:therapeutic use; D000077144:Clopidogrel; D016001:Confidence Intervals; D003324:Coronary Artery Disease / Q000188:drug therapy* / Q000401:mortality / Q000628:therapy; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000627:therapeutic use*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D016016:Proportional Hazards Models; D016032:Randomized Controlled Trials as Topic; D012306:Risk; D040242:Risk Reduction Behavior; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D013988:Ticlopidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D013997:Time Factors
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D007166:Immunosuppressive Agents; D010975:Platelet Aggregation Inhibitors; D000068338:Everolimus; D000077144:Clopidogrel; D013988:Ticlopidine; D017239:Paclitaxel; D001241:Aspirin; D020123:Sirolimus