Boston Scientific EPI: A Carotid Stenting Trial for High-Risk Surgical Patients - BEACH

Description:

The goal of trial was to evaluate whether carotid artery stenting with a distal protection device was non-inferior to historical data for carotid endarterectomy among high-risk surgical patients.

Hypothesis:

Carotid artery stenting with a distal protection device will be non-inferior to historical data for carotid endarterectomy among high-risk surgical patients.

Study Design

Patients Enrolled: 747
Mean Follow Up: 1 year

Primary Endpoints:

Composite of death, stroke, or MI at 1 year.

Drug/Procedures Used:

Patients at 47 US sites were treated with carotid artery stenting with a distal protection device. Data were compared in a non-randomized manner to historical data for surgical carotid endarterectomy derived from a literature review.

Principal Findings:

Procedural success occurred in 98% of patients. The composite endpoint of death, stroke, or MI occurred in 5.6% of patients by 30 days. At 1 year, the composite endpoint had occurred in 9.1% of patients. The literature review control data for carotid endarterectomy estimate was 16.6%. Among the components of the composite endpoint at 1 year in the stenting group, 3.2% had died, 7.0% had a stroke, 1.1% had an MI. Neurologic death or ipsilateral stroke occurred in 3.2% of patients from 30 days to 1 year.

In an additional 189 patients in a "roll-in" phase, the 1 year composite event rate was 8.7%. In an additional 78 patients with bilateral carotid stenoses, the event rate was 7.1%.

Interpretation:

Among patients with carotid stenosis, use of carotid artery stenting with a distal protection device was technically feasible. While the overall one year composite event rate did not appear high, there was no comparator arm in this non-randomized trial, so conclusions regarding efficacy compared with surgical carotid endarterectomy are not possible. The ArCHER trial was a similar trial using a different carotid artery stent system which also reported an event rate in line with historical control data but without a randomized comparison.

References:

Presented by Dr. Katzen at the EuroPCR meeting, Paris France, May 2005.

Iyer SS, White CJ, Hopkins LN, et al. Carotid artery revascularization in high-surgical-risk patients using the Carotid WALLSTENT and FilterWire EX/EZ: 1-year outcomes in the BEACH Pivotal Group. J Am Coll Cardiol. 2008 Jan 29;51(4):427-34

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Vascular Medicine, Interventions and Vascular Medicine

Keywords: Stroke, Endarterectomy, Carotid, Carotid Stenosis, Stents


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