Abbott Vascular to Seek Expanded Indication for CAS With Acculink System Based on CREST Data

May 26, 2010—Abbott Vascular (Santa Clara, CA) announced that based on the strength of data from the CREST (Carotid Revascularization Endarterectomy Versus Stenting Trial) study, which used the company's Acculink carotid stent system and Accunet embolic protection system, the company will seek an expanded indication from the US Food and Drug Administration (FDA) for the Acculink carotid stent system as a treatment option for patients at standard surgical risk. Abbott will also seek coverage from the Centers for Medicare & Medicaid Services for standard-risk patients if the FDA approves the treatment for this broader patient group. The company will submit the results of a previously agreed upon analysis of the CREST data to the FDA by the end of the year. All carotid stent systems in the United States are currently indicated only for high-surgical-risk patients, the company noted.

The CREST results were published by Thomas G. Brott, MD, et al online ahead of print in the New England Journal of Medicine.

According to Abbott Vascular, CREST demonstrated that carotid artery stenting (CAS) and carotid endarterectomy (CEA) had similar initial safety and longer-term outcomes for symptomatic and asymptomatic patients. Adverse event rates of death, stroke, and myocardial infarction were also similar for both therapies. The study was sponsored by the National Institute of Neurological Disorders and Stroke division of the National Institutes of Health, and it was partially funded by Abbott Vascular.

Abbott Vascular stated that CREST demonstrated results consistent with long-standing American Heart Association guidelines for outcomes in patients with severe carotid stenosis. These guidelines state that rates of death and stroke for CEA within 30 days of the procedure should be < 3% for asymptomatic patients and < 6% for symptomatic patients. The company also noted that the rate of cranial nerve palsy during the periprocedural period was 4.7% for the CEA group versus 0.3% for the CAS group (representing crossover stenting patients who also underwent the surgical procedure).

“As a neurosurgeon who has performed both carotid surgeries and carotid stenting procedures, I am pleased to see that carotid stenting and carotid surgery had comparable outcomes for a majority of standard-risk patients in this trial," commented CREST investigator L. Nelson Hopkins III, MD. "Both therapies met the American Heart Association guidelines for patients with carotid narrowing. Experience, training, and patient selection will continue to be of paramount importance in determining success for both treatments."

In addition to CREST, Abbott Vascular is currently enrolling patients in the ACT I randomized clinical trial of patients at standard risk for surgical treatment, which will include up to 1,658 asymptomatic patients younger than 80 years. This multicenter study compares CEA to Abbott's second carotid stent and embolic protection system, the Xact rapid exchange carotid stent system and the Emboshield family of embolic protection systems. Approximately 25,000 patients have been enrolled in nine clinical trials evaluating Abbott's carotid stent systems, the company noted.