Sign in Subscribe
Medical equipment industry

Boston Scientific's BEACH Trial Shows Promising Safety Data on Carotid Stenting

Strategic Insights

— 2 min read

Results from Boston Scientific Corp's BEACH trial on carotid stenting have been hailed as "exciting" by lead investigators, with early safety data indicating a favorable outcome for patients with high-risk carotid artery disease. The trial, which is evaluating the benefits of stenting in conjunction with embolic protection, has enrolled 747 patients at 47 US sites and has a composite primary endpoint of cumulative mortality and morbidity at 30 days and one year. According to Christopher White, Co-Principal Investigator of the trial, the findings should generate interest in less-invasive alternatives for treating carotid artery disease.

Key Takeaways:

  • The BEACH trial is evaluating the benefits of stenting in conjunction with embolic protection for patients with high-risk carotid artery disease, with a focus on symptomatic patients with stenosis of 50% or greater and asymptomatic patients with stenosis of 80% or greater.
  • The trial has enrolled 747 patients at 47 US sites, with 480 patients in the pivotal phase of the trial.
  • The primary endpoint of the trial is a composite of cumulative mortality and morbidity at 30 days and one year, which includes stroke, death, and myocardial infarction (MI).
  • The early safety data from the trial are consistent with the primary endpoints and compare favorably with other high-risk carotid artery stenting trials.
  • The trial's findings support the addition of embolic protection to carotid stenting procedures, which is a less-invasive alternative for treating carotid artery disease.
  • The one-year BEACH trial results will be available in the second quarter of 2005.

Statistics:

  • 747 patients have been enrolled in the BEACH trial at 47 US sites.
  • 480 patients are in the pivotal phase of the trial.
  • The trial includes patients with stenosis of 50% or greater (symptomatic) and stenosis of 80% or greater (asymptomatic).
  • The primary endpoint of the trial includes a composite of cumulative mortality and morbidity at 30 days and one year, which includes stroke, death, and myocardial infarction (MI).
  • The early safety data from the trial are consistent with the primary endpoints and compare favorably with other high-risk carotid artery stenting trials.
  • 30-day safety data have been released, with one-year results expected in the second quarter of 2005.

Sources:

  • Boston Scientific Corp press release: not available online
  • 13th Annual Peripheral Angioplasty and All That Jazz meeting, New Orleans, USA
  • Christopher White, Co-Principal Investigator of the BEACH trial, Director of the Ochsner Heart and Vascular Institute in New Orleans, and Chairman of Ochsner's Department of Cardiology.

Read more