title: Outcomes after carotid artery stenting in Medicare beneficiaries, 2005 to 2009.
abstract: OBJECTIVE
  Despite increased carotid artery stenting (CAS) dissemination following the 2005 National Coverage Determination, to our knowledge, periprocedural and long-term outcomes have not been described among Medicare beneficiaries.
  
  
  OBJECTIVE
  To describe the incidence of outcomes during and after the periprocedural period among Medicare beneficiaries undergoing CAS.
  
  
  METHODS
  Observational study with a mean follow-up time of approximately 2 years among 22,516 fee-for-service Medicare beneficiaries at least 66 years old undergoing CAS (2005-2009) who were linked to the Centers for Medicare & Medicaid Services' CAS database. Database procedure dates were required to fall during a Medicare hospitalization for CAS.
  
  
  METHODS
  Periprocedural (30-day) and long-term risks of mortality and stroke or transient ischemic attack, as well as periprocedural myocardial infarction. Subgroups were based on sociodemographic, clinical, and center-level factors, as well as the Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) trial or Carotid Revascularization Endarterectomy vs Stenting Trial (CREST) enrollment criteria.
  
  
  RESULTS
  The mean patient age was 76.3 years, 60.5% were male, 93.8% were of white race, 91.2% were at high surgical risk, 47.4% were symptomatic, and 97.4% had carotid stenosis of at least 70%. Crude 30-day mortality, stroke or transient ischemic attack, and myocardial infarction risks were 1.7% (95% CI, 1.5%-1.8%), 3.3% (95% CI, 3.0%-3.5%), and 2.5% (95% CI, 2.3%-2.7%), respectively. Mortality during a mean follow-up time of 2 years was 32.0% (95% CI, 31.0%-33.0%), with rates of 37.3% (95% CI, 35.8%-38.7%) among symptomatic patients and 27.7% (95% CI, 26.4%-28.9%) among asymptomatic patients. Older age, symptomatic carotid stenosis, and nonelective hospital admission were associated with increased adjusted hazards of mortality and stroke or transient ischemic attack during and after the periprocedural period. The presence of a stroke center, government ownership, and a hospital bed capacity of 500 or more were associated with increased adjusted hazards of periprocedural mortality and stroke or transient ischemic attack. Few patients met the SAPPHIRE trial or CREST enrollment criteria primarily because physicians did not meet proficiency requirements either due to exceeding periprocedural complication trial thresholds or not meeting minimum CAS volume requirements.
  
  
  CONCLUSIONS
  Competing risks may limit the benefits of CAS in certain Medicare beneficiaries, particularly among older and symptomatic patients who have higher periprocedural and long-term mortality risks. The generalizability of trials like the SAPPHIRE or CREST to the Medicare population may be limited, underscoring the need to evaluate real-world effectiveness of carotid stenosis treatments.
authors.affiliation: Division of Pharmacoepidemiology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts2LASER ANALYTICA, New York, New York.
authors.forename: Jessica J
authors.initials: JJ
authors.lastname: Jalbert
authors.affiliation: Division of Vascular and Endovascular Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Louis L
authors.initials: LL
authors.lastname: Nguyen
authors.affiliation: Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Marie D
authors.initials: MD
authors.lastname: Gerhard-Herman
authors.affiliation: Division of Cardiovascular Medicine, Massachusetts General Hospital, Boston.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Jaff
authors.affiliation: Ochsner Clinical School, Ochsner Medical Center, New Orleans, Louisiana.
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: White
authors.affiliation: Division of Pharmacoepidemiology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Andrew T
authors.initials: AT
authors.lastname: Rothman
authors.affiliation: Division of Pharmacoepidemiology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts7OptumInsight Epidemiology, Waltham, Massachusetts.
authors.forename: John D
authors.initials: JD
authors.lastname: Seeger
authors.affiliation: Division of Pharmacoepidemiology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Hiraku
authors.initials: H
authors.lastname: Kumamaru
authors.affiliation: Division of Pharmacoepidemiology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Lauren A
authors.initials: LA
authors.lastname: Williams
authors.affiliation: Division of Pharmacoepidemiology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Chih-Ying
authors.initials: CY
authors.lastname: Chen
authors.affiliation: Division of Pharmacoepidemiology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Jun
authors.initials: J
authors.lastname: Liu
authors.affiliation: Division of Cardiology, Denver Veterans Affairs Medical Center, University of Colorado, Denver.
authors.forename: Thomas T
authors.initials: TT
authors.lastname: Tsai
authors.affiliation: Division of Cardiovascular Medicine, St Joseph Mercy Ann Arbor, Ann Arbor, Michigan.
authors.forename: Herbert D
authors.initials: HD
authors.lastname: Aronow
authors.affiliation: Global Health Outcomes, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana.
authors.forename: Joseph A
authors.initials: JA
authors.lastname: Johnston
authors.affiliation: Department of Neurology, Mayo Clinic, Jacksonville, Florida.
authors.forename: Thomas G
authors.initials: TG
authors.lastname: Brott
authors.affiliation: Division of Pharmacoepidemiology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts12Department of Medicine, Duke Clinical Research Institute, Durham, North Carolina.
authors.forename: Soko
authors.initials: S
authors.lastname: Setoguchi
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D016893:Carotid Stenosis / Q000401:mortality* / Q000601:surgery*; D015331:Cohort Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007342:Insurance Benefits / Q000639:trends*; D008297:Male; D006278:Medicare / Q000639:trends*; D012189:Retrospective Studies; D012307:Risk Factors; D015607:Stents; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology