title: Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease.
abstract: BACKGROUND
  In patients with coronary artery disease who receive metallic drug-eluting coronary stents, adverse events such as late target-lesion failure may be related in part to the persistent presence of the metallic stent frame in the coronary-vessel wall. Bioresorbable vascular scaffolds have been developed to attempt to improve long-term outcomes.
  
  
  METHODS
  In this large, multicenter, randomized trial, 2008 patients with stable or unstable angina were randomly assigned in a 2:1 ratio to receive an everolimus-eluting bioresorbable vascular (Absorb) scaffold (1322 patients) or an everolimus-eluting cobalt-chromium (Xience) stent (686 patients). The primary end point, which was tested for both noninferiority (margin, 4.5 percentage points for the risk difference) and superiority, was target-lesion failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization) at 1 year.
  
  
  RESULTS
  Target-lesion failure at 1 year occurred in 7.8% of patients in the Absorb group and in 6.1% of patients in the Xience group (difference, 1.7 percentage points; 95% confidence interval, -0.5 to 3.9; P=0.007 for noninferiority and P=0.16 for superiority). There was no significant difference between the Absorb group and the Xience group in rates of cardiac death (0.6% and 0.1%, respectively; P=0.29), target-vessel myocardial infarction (6.0% and 4.6%, respectively; P=0.18), or ischemia-driven target-lesion revascularization (3.0% and 2.5%, respectively; P=0.50). Device thrombosis within 1 year occurred in 1.5% of patients in the Absorb group and in 0.7% of patients in the Xience group (P=0.13).
  
  
  CONCLUSIONS
  In this large-scale, randomized trial, treatment of noncomplex obstructive coronary artery disease with an everolimus-eluting bioresorbable vascular scaffold, as compared with an everolimus-eluting cobalt-chromium stent, was within the prespecified margin for noninferiority with respect to target-lesion failure at 1 year. (Funded by Abbott Vascular; ABSORB III ClinicalTrials.gov number, NCT01751906.).
authors.affiliation: From Cleveland Clinic, Cleveland (S.G.E.), the Christ Hospital, Heart and Vascular Center, Lindner Research Center, Cincinnati (D.J.K.), and Mercy St. Vincent's Medical Center, Toledo (A. Kini) - all in Ohio; Wellmont Holston Valley Medical Center, Kingsport, TN (D.C.M.); St. Joseph's Hospital Health Center, Liverpool, NY (R.P.C.); Scottsdale Healthcare, Scottsdale, AZ (D.G.R.); Scripps Clinic, La Jolla (P.S.T.), and Abbott Vascular, Santa Clara (R.M., Z.Z., C.S.) - both in California; Baptist Medical Center, Jacksonville, FL (M.R.L.); Mount Sinai Medical Center (A. Kabour), Columbia University Medical Center (S.O.M., G.W.S.), and the Cardiovascular Research Foundation (G.W.S.) - all in New York; and the Beth Israel Deaconess Medical Center, Boston (J.J.P.).
authors.forename: Stephen G
authors.initials: SG
authors.lastname: Ellis
authors.forename: Dean J
authors.initials: DJ
authors.lastname: Kereiakes
authors.forename: D Christopher
authors.initials: DC
authors.lastname: Metzger
authors.forename: Ronald P
authors.initials: RP
authors.lastname: Caputo
authors.forename: David G
authors.initials: DG
authors.lastname: Rizik
authors.forename: Paul S
authors.initials: PS
authors.lastname: Teirstein
authors.forename: Marc R
authors.initials: MR
authors.lastname: Litt
authors.forename: Annapoorna
authors.initials: A
authors.lastname: Kini
authors.forename: Ameer
authors.initials: A
authors.lastname: Kabour
authors.forename: Steven O
authors.initials: SO
authors.lastname: Marx
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Popma
authors.forename: Robert
authors.initials: R
authors.lastname: McGreevy
authors.forename: Zhen
authors.initials: Z
authors.lastname: Zhang
authors.forename: Charles
authors.initials: C
authors.lastname: Simonton
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D000787:Angina Pectoris / Q000628:therapy; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis; D054855:Drug-Eluting Stents / Q000009:adverse effects; D000068338:Everolimus / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D053208:Kaplan-Meier Estimate; D008297:Male; D008670:Metals; D008875:Middle Aged; D011474:Prosthesis Design
chemical_list: D007166:Immunosuppressive Agents; D008670:Metals; D000068338:Everolimus