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SAPPHIRE trial shows long-term benefit of carotid stenting as alternative to surgery

April 11, 2008

Carotid artery stenting is an effective option for high risk patients who are not eligible for surgery, according to a long-term study published in this week's New England Journal of Medicine. Carotid artery disease, which involves clogging of the arteries in the neck that provide blood to the brain, is a significant risk factor for stroke, making these study results important for the estimated 200,000 Americans each year who would otherwise not be candidates for the treatment.

The SAPPHIRE trial showed patients undergoing carotid stenting were comparably protected from stroke, heart attack, death, and repeat revascularization procedures as patients who underwent the traditional surgical approach (endarterectomy). SAPPHIRE is the first and longest (three years) randomized study to compare the safety and efficacy of carotid stenting with embolic protection to surgery in high risk patients. High risk patients are considered to be at increased risk for surgery because of prior carotid artery surgery, radiation to the neck, chronic heart failure, lung disease or severe coronary artery disease, among other criteria.

The Society for Cardiovascular Angiography and Interventions (SCAI), the world's leading society of interventional cardiologists, is encouraged by these positive data. Results are consistent with one-year SAPPHIRE data and echo conclusions from other non-randomized trials supporting the use of carotid stenting, particularly in patients with multiple illnesses.

"This is more good news for patients who otherwise might not have treatment options," said Dr. Bonnie Weiner, president of the Society for Cardiovascular Angiography and Interventions. "Carotid artery stenting is an effective, safe way to help patients avoid debilitating and potentially fatal strokes. We are hopeful that this news will help pave the way for expanded use of this procedure."

Carotid Artery Stenting

Carotid artery stenting is a non-surgical, percutaneous procedure in which a small plastic tube called a catheter is inserted through an artery in the leg and threaded to the blockage in the neck. A thin wire (guidewire), which has a collapsible umbrella-like filter device attached to its end, is advanced passed the blockage. The umbrella is opened and acts as a filter to the blood flowing to the brain, preventing particles from passing to the brain and causing stroke while opening up the blockage and inserting a tiny mesh tube called a stent. The blocked artery is then dilated by inflating a balloon, which pushes the plaque in the artery against its walls and makes way for the stent, which is inserted to prop open the artery. Once the stent is in place, the umbrella filter is removed.

SAPPHIRE

SAPPHIRE, a multi-center, prospective, randomized study, evaluated the safety and performance of the Cordis PRECISE® Nitinol Stent and AngioGuard® Emboli Capture Guidewire, compared with surgery, in 334 patients with carotid artery stenosis. The pre-specified major secondary endpoint at three years was a composite of death, stroke, or myocardial infarction within 30 days after the procedure or death or ipsilateral stroke (occurring on the same side) between 31 days and three years.

At three years, data were available for 260 patients, 85.6 percent of patients (143 of 167) in the stenting group and 70.1 percent of patients (117 of 167) in the surgery group. The pre-specified major secondary endpoint occurred in 41 of the 167 patients who underwent stenting (cumulative incidence, 24.6 percent) and in 45 of 167 patients who underwent endarterectomy (cumulative incidence, 26.9 percent). There was no statistical significance between these groups. Target-vessel revascularization (a procedure to re-open the blocked arteries) was infrequent in both groups.

Although this report is specific to the products mentioned above, it is consistent with results from registries using other similar devices. This supports the overall role of carotid stenting in this patient population.

Society for Cardiovascular Angiography and Interventions