title: Clinical outcomes in real-world patients with acute myocardial infarction receiving XIENCE V® everolimus-eluting stents: one-year results from the XIENCE V USA study.
abstract: OBJECTIVE
  The objective of this analysis was to evaluate the safety and effectiveness of XIENCE V in acute myocardial infarction (AMI).
  
  
  BACKGROUND
  The XIENCE V(®) Everolimus-eluting coronary stent was superior to the TAXUS(®) paclitaxel-eluting stent in angiographic and clinical outcomes in the SPIRIT II, III, and IV randomized controlled trials, but patients with AMI were excluded.
  
  
  METHODS
  XIENCE V USA is a large, prospective, multicenter, real-world single-arm postmarket surveillance trial. Consecutive patients undergoing PCI with XIENCE V were enrolled. For this analysis, clinical outcomes in 673 patients presenting with AMI (STEMI, n = 125) were as compared to patients without AMI (n = 3528) at 1 year.
  
  
  RESULTS
  At 1 year, ARC-defined stent thrombosis (ST) rates were 1.08% in AMI vs. 0.85% in the non-AMI group (P = 0.4987). The late ST (30 days-1 year) rates were 0.31% vs. 0.47% (AMI vs. non-AMI, P = 0.7551). Rates of target lesion revascularization (TLR) were 4.1% vs. 4.6% (P = 0.6104), and rates of target lesion failure (TLF) were 9.1% vs. 8.5%, (P = 0.5964). With the historical WHO definition of MI, 1 year TLF rates were 7.0% vs. 6.7% (P = 0.8001). Improvements in quality of life, angina frequency, angina stability, and physical limitations occurred at 6 months (each P < 0.0001) and were sustained at 1 year in both groups. There were no significant differences in clinical outcomes between STEMI and non-STEMI patients.
  
  
  CONCLUSIONS
  At 1 year, AMI patients treated with XIENCE V had low rates of ST, TLR, and TLF, similar to non-AMI patients. Marked improvements in patients' health status in this subgroup were also demonstrated.
authors.affiliation: Center for Cardiovascular Technology, Stanford University, Palo Alto, California; Abbott Vascular, Santa Clara, California.
authors.forename: Krishnankutty
authors.initials: K
authors.lastname: Sudhir
authors.forename: James B
authors.initials: JB
authors.lastname: Hermiller
authors.forename: Srihari S
authors.initials: SS
authors.lastname: Naidu
authors.forename: Timothy D
authors.initials: TD
authors.lastname: Henry
authors.forename: Vivian W
authors.initials: VW
authors.lastname: Mao
authors.forename: Weiying
authors.initials: W
authors.lastname: Zhao
authors.forename: Joanne M
authors.initials: JM
authors.lastname: Ferguson
authors.forename: Jin
authors.initials: J
authors.lastname: Wang
authors.forename: Lalitha
authors.initials: L
authors.lastname: Jonnavithula
authors.forename: Charles A
authors.initials: CA
authors.lastname: Simonton
authors.forename: David R
authors.initials: DR
authors.lastname: Rutledge
authors.forename: Mitchell W
authors.initials: MW
authors.lastname: Krucoff
mesh_terms: D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D003328:Coronary Thrombosis / Q000209:etiology; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D002317:Cardiovascular Agents; D000068338:Everolimus; D020123:Sirolimus