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SAPPHIRE trial shows long-term benefit of carotid stenting as alternative to surgery
Date:4/10/2008

id 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 wit
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Contact: Kathy Boyd David
kbdavid@scai.org
712-422-1181
Society for Cardiovascular Angiography and Interventions
Source:Eurekalert

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