title: Randomized Trial of Stent versus Surgery for Asymptomatic Carotid Stenosis.
abstract: BACKGROUND
  Previous clinical trials have suggested that carotid-artery stenting with a device to capture and remove emboli ("embolic protection") is an effective alternative to carotid endarterectomy in patients at average or high risk for surgical complications.
  
  
  METHODS
  In this trial, we compared carotid-artery stenting with embolic protection and carotid endarterectomy in patients 79 years of age or younger who had severe carotid stenosis and were asymptomatic (i.e., had not had a stroke, transient ischemic attack, or amaurosis fugax in the 180 days before enrollment) and were not considered to be at high risk for surgical complications. The trial was designed to enroll 1658 patients but was halted early, after 1453 patients underwent randomization, because of slow enrollment. Patients were followed for up to 5 years. The primary composite end point of death, stroke, or myocardial infarction within 30 days after the procedure or ipsilateral stroke within 1 year was tested at a noninferiority margin of 3 percentage points.
  
  
  RESULTS
  Stenting was noninferior to endarterectomy with regard to the primary composite end point (event rate, 3.8% and 3.4%, respectively; P=0.01 for noninferiority). The rate of stroke or death within 30 days was 2.9% in the stenting group and 1.7% in the endarterectomy group (P=0.33). From 30 days to 5 years after the procedure, the rate of freedom from ipsilateral stroke was 97.8% in the stenting group and 97.3% in the endarterectomy group (P=0.51), and the overall survival rates were 87.1% and 89.4%, respectively (P=0.21). The cumulative 5-year rate of stroke-free survival was 93.1% in the stenting group and 94.7% in the endarterectomy group (P=0.44).
  
  
  CONCLUSIONS
  In this trial involving asymptomatic patients with severe carotid stenosis who were not at high risk for surgical complications, stenting was noninferior to endarterectomy with regard to the rate of the primary composite end point at 1 year. In analyses that included up to 5 years of follow-up, there were no significant differences between the study groups in the rates of non-procedure-related stroke, all stroke, and survival. (Funded by Abbott Vascular; ACT I ClinicalTrials.gov number, NCT00106938.).
authors.affiliation: From Massachusetts General Hospital, Boston (K.R., M.R.J.); the University of Wisconsin, Madison (J.S.M.); the University of Miami, Miami (S.C.); NYU Langone School of Medicine, New York (T.R.); Ohio Health System, Columbus (G.M.A.); Wellmont Cardiovascular Associates Heart Institute, Kingsport, TN (D.C.M.); the University of Pittsburgh Medical Center, Pittsburgh (L.W.); and the Main Line Health System, Philadelphia (W.G.).
authors.forename: Kenneth
authors.initials: K
authors.lastname: Rosenfield
authors.affiliation: From Massachusetts General Hospital, Boston (K.R., M.R.J.); the University of Wisconsin, Madison (J.S.M.); the University of Miami, Miami (S.C.); NYU Langone School of Medicine, New York (T.R.); Ohio Health System, Columbus (G.M.A.); Wellmont Cardiovascular Associates Heart Institute, Kingsport, TN (D.C.M.); the University of Pittsburgh Medical Center, Pittsburgh (L.W.); and the Main Line Health System, Philadelphia (W.G.).
authors.forename: Jon S
authors.initials: JS
authors.lastname: Matsumura
authors.affiliation: From Massachusetts General Hospital, Boston (K.R., M.R.J.); the University of Wisconsin, Madison (J.S.M.); the University of Miami, Miami (S.C.); NYU Langone School of Medicine, New York (T.R.); Ohio Health System, Columbus (G.M.A.); Wellmont Cardiovascular Associates Heart Institute, Kingsport, TN (D.C.M.); the University of Pittsburgh Medical Center, Pittsburgh (L.W.); and the Main Line Health System, Philadelphia (W.G.).
authors.forename: Seemant
authors.initials: S
authors.lastname: Chaturvedi
authors.affiliation: From Massachusetts General Hospital, Boston (K.R., M.R.J.); the University of Wisconsin, Madison (J.S.M.); the University of Miami, Miami (S.C.); NYU Langone School of Medicine, New York (T.R.); Ohio Health System, Columbus (G.M.A.); Wellmont Cardiovascular Associates Heart Institute, Kingsport, TN (D.C.M.); the University of Pittsburgh Medical Center, Pittsburgh (L.W.); and the Main Line Health System, Philadelphia (W.G.).
authors.forename: Tom
authors.initials: T
authors.lastname: Riles
authors.affiliation: From Massachusetts General Hospital, Boston (K.R., M.R.J.); the University of Wisconsin, Madison (J.S.M.); the University of Miami, Miami (S.C.); NYU Langone School of Medicine, New York (T.R.); Ohio Health System, Columbus (G.M.A.); Wellmont Cardiovascular Associates Heart Institute, Kingsport, TN (D.C.M.); the University of Pittsburgh Medical Center, Pittsburgh (L.W.); and the Main Line Health System, Philadelphia (W.G.).
authors.forename: Gary M
authors.initials: GM
authors.lastname: Ansel
authors.affiliation: From Massachusetts General Hospital, Boston (K.R., M.R.J.); the University of Wisconsin, Madison (J.S.M.); the University of Miami, Miami (S.C.); NYU Langone School of Medicine, New York (T.R.); Ohio Health System, Columbus (G.M.A.); Wellmont Cardiovascular Associates Heart Institute, Kingsport, TN (D.C.M.); the University of Pittsburgh Medical Center, Pittsburgh (L.W.); and the Main Line Health System, Philadelphia (W.G.).
authors.forename: D Chris
authors.initials: DC
authors.lastname: Metzger
authors.affiliation: From Massachusetts General Hospital, Boston (K.R., M.R.J.); the University of Wisconsin, Madison (J.S.M.); the University of Miami, Miami (S.C.); NYU Langone School of Medicine, New York (T.R.); Ohio Health System, Columbus (G.M.A.); Wellmont Cardiovascular Associates Heart Institute, Kingsport, TN (D.C.M.); the University of Pittsburgh Medical Center, Pittsburgh (L.W.); and the Main Line Health System, Philadelphia (W.G.).
authors.forename: Lawrence
authors.initials: L
authors.lastname: Wechsler
authors.affiliation: From Massachusetts General Hospital, Boston (K.R., M.R.J.); the University of Wisconsin, Madison (J.S.M.); the University of Miami, Miami (S.C.); NYU Langone School of Medicine, New York (T.R.); Ohio Health System, Columbus (G.M.A.); Wellmont Cardiovascular Associates Heart Institute, Kingsport, TN (D.C.M.); the University of Pittsburgh Medical Center, Pittsburgh (L.W.); and the Main Line Health System, Philadelphia (W.G.).
authors.forename: Michael R
authors.initials: MR
authors.lastname: Jaff
authors.affiliation: From Massachusetts General Hospital, Boston (K.R., M.R.J.); the University of Wisconsin, Madison (J.S.M.); the University of Miami, Miami (S.C.); NYU Langone School of Medicine, New York (T.R.); Ohio Health System, Columbus (G.M.A.); Wellmont Cardiovascular Associates Heart Institute, Kingsport, TN (D.C.M.); the University of Pittsburgh Medical Center, Pittsburgh (L.W.); and the Main Line Health System, Philadelphia (W.G.).
authors.forename: William
authors.initials: W
authors.lastname: Gray
mesh_terms: D000328:Adult; D000368:Aged; D017130:Angioplasty / Q000009:adverse effects; D000925:Anticoagulants / Q000627:therapeutic use; D016893:Carotid Stenosis / Q000150:complications / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D018572:Disease-Free Survival; D016894:Endarterectomy, Carotid / Q000009:adverse effects; D005260:Female; D006801:Humans; D015994:Incidence; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D015607:Stents; D020521:Stroke / Q000453:epidemiology / Q000517:prevention & control*; D015996:Survival Rate
chemical_list: D000925:Anticoagulants