Neuroprotection during carotid artery stenting using the GORE flow reversal system: 30-day outcomes in the EMPiRE Clinical Study

Daniel G. Clair, L. Nelson Hopkins, Manish Mehta, Karthikeshwar Kasirajan, Marc Schermerhorn, Claudio Schönholz, Christopher J. Kwolek, Mark K. Eskandari, Richard J. Powell, Gary M. Ansel

Research output: Contribution to journalArticle

102 Scopus citations

Abstract

Background: Each of the embolic protection devices used in carotid artery stenting (CAS) has advantages and disadvantages. The prospective, multicenter, single-arm EMPiRE Clinical Study investigated a proximally placed device (GORE Flow Reversal System) that provides distal neuroprotection during CAS by reversing blood flow in the internal carotid artery, thereby directing emboli away from the brain. Methods: The study evaluated 30-day outcomes in 245 pivotal high-surgical-risk patients (mean age, 70 years; 32% symptomatic; 16% ≥80-years old) with carotid stenosis who underwent CAS using the flow reversal system. The primary endpoint was a major adverse event (MAE; stroke, death, myocardial infarction, or transient ischemic attack) within 30 days of CAS. The MAE rate was compared with an objective performance criterion (OPC) derived from CAS studies that included embolic protection. Results: The MAE rate was 4.5% (11 patients; P = 0.002 compared with the OPC). The stroke and death rate was 2.9%. No patient had a major ischemic stroke. Six patients (2.4%) had intolerance to flow reversal. The death and stroke rates in the symptomatic, asymptomatic, and octogenarian subgroups were 2.6, 3, and 2.6%, respectively, meeting American Heart Association guidelines for carotid endarterectomy. Conclusion: The stroke and death rate in this study was among the lowest in CAS trials. The results indicate that the flow reversal system is safe and effective when used for neuroprotection during CAS and that it provides benefits in a broad patient population.

Original languageEnglish (US)
Pages (from-to)420-429
Number of pages10
JournalCatheterization and Cardiovascular Interventions
Volume77
Issue number3
DOIs
StatePublished - Feb 15 2011

Keywords

  • angioplasty
  • carotid arteries
  • embolism
  • stents
  • stroke

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

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    Clair, D. G., Hopkins, L. N., Mehta, M., Kasirajan, K., Schermerhorn, M., Schönholz, C., Kwolek, C. J., Eskandari, M. K., Powell, R. J., & Ansel, G. M. (2011). Neuroprotection during carotid artery stenting using the GORE flow reversal system: 30-day outcomes in the EMPiRE Clinical Study. Catheterization and Cardiovascular Interventions, 77(3), 420-429. https://doi.org/10.1002/ccd.22789