title: Secondary procedures following thoracic aortic stent grafting in the first 3 years of the VALOR test and VALOR II trials.
abstract: OBJECTIVE
  To compare the durability of thoracic endovascular aortic repair (TEVAR) in two similar clinical trials that used early- and later-generation stent grafts.
  
  
  METHODS
  Secondary procedures from the prospective, nonrandomized, multicenter, clinical trial databases of the test arm of the VALOR and VALOR II trials were analyzed at 3 years. Descriptive and statistical analyses were employed to compare the rate of and potential predictors for secondary procedures.
  
  
  RESULTS
  A total of 127 and 96 patients were available for a minimum of 3 years of follow-up in the test arm of VALOR and VALOR II, respectively. By the first year after the index procedure, VALOR II patients were significantly less likely to have undergone a secondary procedure versus patients in the test arm of VALOR (odds ratio [OR], 0.08; 95% confidence interval [CI], 0.01-0.63; P = .02), with most procedures performed for type I endoleak. Multivariate predictors at 3 years for the need for a secondary procedure in the VALOR test arm were maximum aneurysm diameter (P = .002) and aneurysm length (P = .01), both of which remained significant at the end of the study period. The estimated freedoms from secondary procedures in the VALOR test arm and VALOR II at 3 years were 85.1% (95% CI, 78.5%-89.8%) and 94.9% (95% CI, 88.8%-97.7%), respectively (P < .001).
  
  
  CONCLUSIONS
  The rate of secondary procedures after TEVAR differed between the two cohorts, being substantially lower in the VALOR II trial at 1 year of follow-up. This finding suggests significant benefit from advances in some combination of operator experience, imaging systems, treatment planning, and device design.
authors: Department of Radiology and Medical Imaging, University of Virginia Health System, 1215 Lee St., Box 800170, Room 1839, Charlottesville, VA 22908. Electronic address: ahm4d@virginia.edu.
authors: Alan H
authors: AH
authors: Matsumoto
authors: Department of Radiology and Medical Imaging, University of Virginia Health System, 1215 Lee St., Box 800170, Room 1839, Charlottesville, VA 22908.
authors: John F
authors: JF
authors: Angle
authors: Secic Statistical Consulting, Chardon, Ohio.
authors: Michelle
authors: M
authors: Secic
authors: Office of Medical Affairs, Medtronic Vascular, Santa Rosa, California.
authors: Grace A
authors: GA
authors: Carlson
authors: Office of Medical Affairs, Medtronic Vascular, Santa Rosa, California.
authors: Lois
authors: L
authors: Fisher
authors: Division of Vascular Surgery and Endovascular Therapy, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania.
authors: Ronald M
authors: RM
authors: Fairman
mesh_terms: D000328:Adult; D000368:Aged; D017545:Aortic Aneurysm, Thoracic / Q000601:surgery*; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology*; D015995:Prevalence; D012086:Reoperation / Q000706:statistics & numerical data; D012307:Risk Factors; D015607:Stents / Q000706:statistics & numerical data*; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D058017:Vascular Grafting / Q000706:statistics & numerical data*; D014656:Vascular Surgical Procedures / Q000706:statistics & numerical data*