title: Clinical outcomes in real-world patients with bifurcation lesions receiving Xience V everolimus-eluting stents: Four-year results from the Xience V USA study.
abstract: BACKGROUND
  The Xience V USA Study demonstrated safety and efficacy of the XIENCE V(®) everolimus-eluting stent (EES) in a large, prospective study of a real-world, unselected patient population. There is limited long-term data regarding EES performance in high risk patients with bifurcation lesions (BIF). The objective of this analysis was to evaluate the long-term safety and effectiveness of EES in patients with BIF from the XIENCE V USA study.
  
  
  METHODS
  The Xience V USA Study was a single arm, prospective, multicenter, real-world study (n = 5,054) undergoing PCI with EES. Baseline data and clinical outcomes at 4 years were evaluated in the subgroup of patients with ≥ 1 BIF who did not undergo a staged procedure. Co-primary endpoints were ARC definite/probable stent thrombosis and a composite of cardiac death and ARC-defined myocardial infarction (MI). Endpoints were adjudicated by an independent CEC.
  
  
  RESULTS
  Of 4,768 patients who did not undergo a staged procedure, there were 511 (10.7%) patients with BIF and 4,257 (89.3%) patients without BIF. Follow-up data was available in 4,459 patients (466 BIF, 3,993 non-BIF). Through binary outcome analysis, at 1 year the overall definite/probable stent thrombosis rates were higher in the BIF group (1.84% vs. 0.76%, P = 0.03). However, at 4 years, the difference in cumulative rates of ARC definite/probable stent thrombosis (BIF 2.3% vs. non-BIF 1.4%, P = 0.13) remained the same as that at 1 year, with no incremental definite/probable stent thrombosis in BIF patients from 2-4 years. The 4-year rates of composite cardiac death and MI were 13.5% for BIF vs. 14.1% for non-BIF (P = 0.78). At 4 years, target lesion failure (19.1% vs. 18.3%, P = 0.66) and ischemia driven-target lesion revascularization (10.2% vs. 10.1%, P = 0.89) were comparable between the two groups.
  
  
  CONCLUSIONS
  This subgroup analysis of BIF lesions in a real world population receiving EES demonstrates continued low rates of clinical outcomes in the BIF subgroup at 4 years with no incremental stent thrombosis increase in BIF patients from 2 to 4 years. © 2015 Wiley Periodicals, Inc.
authors.affiliation: St. Vincent's Heart Center of Indianapolis, Indiana.
authors.forename: James B
authors.initials: JB
authors.lastname: Hermiller
authors.affiliation: Wake Forest University Health Sciences, Wake Forest, North Carolina.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Applegate
authors.affiliation: Abbott Vascular, Santa Clara, California.
authors.forename: Colleen
authors.initials: C
authors.lastname: Baird
authors.affiliation: Wake Forest University Health Sciences, Wake Forest, North Carolina.
authors.forename: Michael M
authors.initials: MM
authors.lastname: Butler
authors.affiliation: Abbott Vascular, Santa Clara, California.
authors.forename: David
authors.initials: D
authors.lastname: Rutledge
authors.affiliation: Abbott Vascular, Santa Clara, California.
authors.forename: Jin
authors.initials: J
authors.lastname: Wang
authors.affiliation: Abbott Vascular, Santa Clara, California.
authors.forename: Kalyan
authors.initials: K
authors.lastname: Kakarala
authors.affiliation: Duke University Medical Center, Durham, North Carolina.
authors.forename: Mitchell W
authors.initials: MW
authors.lastname: Krucoff
authors.affiliation: Abbott Vascular, Santa Clara, California.
authors.forename: Krishnankutty
authors.initials: K
authors.lastname: Sudhir
mesh_terms: D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D003328:Coronary Thrombosis / Q000209:etiology; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D002317:Cardiovascular Agents; D000068338:Everolimus
keywords: bifurcation intervention; everolimus-eluting stent; stent