CABANA Data Published for Boston Scientific's Carotid Wallstent With FilterWire EZ System

November 28, 2014—The results of the prospective, multicenter, nonrandomized CABANA study were published by L. Nelson Hopkins, MD, et al in Catheterization and Cardiovascular Interventions (2014;84:997–1004). The background of the study is that there is a need for additional evidence evaluating carotid artery stenting (CAS) performed by operators with various experience and training levels, stated the investigators.

CABANA sought to evaluate periprocedural clinical outcomes in high-surgical-risk patients with carotid artery stenosis who were treated with the carotid Wallstent Monorail endoprosthesis plus FilterWire EZ embolic protection system (Boston Scientific Corporation) by a diverse group of clinicians.

Dr. Hopkins previously presented the analysis from the CABANA postapproval study in November 2011 at the annual Transcatheter Cardiovascular Therapeutics scientific symposium in San Francisco, California.

As summarized in Catheterization and Cardiovascular Interventions, the CABANA study enrolled symptomatic patients with ≥ 50% carotid artery stenosis and asymptomatic patients with ≥ 80% carotid stenosis who were at high risk for carotid endarterectomy. Study centers were grouped into three tiers based on previous CAS experience, and individual operators were grouped by their CAS training. The primary endpoint was the 30-day composite of major adverse events (MAE), including stroke, death, and myocardial infarction (MI). Individual event rates were evaluated across the overall study, and by center experience and physician training tier.

The investigators reported that 1,025 of the 1,097 enrolled patients were evaluable for 30-day MAE rate. The stroke rate of 3.3% was a major contributing factor in the overall MAE rate of 4.6%. Mortality was 1.3%, and the MI rate was 0.5%. There was no statistically significant association between MAE rates among the center experience tiers (P = .61), nor among the operator training categories (P = .26).

CAS with the carotid Wallstent and FilterWire EZ system yielded a low 30-day MAE rate that did not differ significantly across operator experience and training levels, concluded the investigators in Catheterization and Cardiovascular Interventions.