CHICAGO, IL (November 19, 2002) – Researchers at today’s American Heart Association (AHA) Scientific Session presented 30-day interim findings for the SAPPHIRE* study—the first randomized multi-center trial comparing the safety and efficacy of carotid artery stenting (CAS) with embolic protection to carotid endarterectomy in high surgical risk patients. The SAPPHIRE trial is also the only active study to include a randomization of high surgical risk patients comparing CAS with endarterectomy (CEA) patients. The trial was sponsored by Cordis Endovascular, a division of Cordis Corporation, a Johnson & Johnson company.
“The interim findings for the SAPPHIRE study are very encouraging,” said Dennis Donohoe, M.D., Vice President of Therapeutics and Clinical Research for Cordis. “It is critical that we identify a safe, effective alternative to CEA for the thousands of patients with carotid artery blockages who are at high risk for surgical treatment.”
Of the 307 patients in the randomized arm of the study, 156 received Cordis’ PRECISE™ Nitinol Self-Expanding Stent—in combination with the ANGIOGUARD™ or ANGIOGUARD™ XP Emboli Capture Guidewire†. The remaining 151 patients underwent CEA. At 30-day follow-up, the major adverse event (MAE—defined as death, stroke, or myocardial infarction) rate for the randomized stented group was 5.8 % vs12.6% for the endarterectomy-treated patients, a statistically significant improvement.
“We are extremely impressed with the performance of the PRECISE Stent with ANGIOGUARD XP Guidewire protection,” said SAPPHIRE Trial Investigator Jay Yadav, MD, Director of Vascular Intervention, Department of Cardiovascular Medicine, Cleveland Clinic Foundation. “While these results are preliminary, the 30-day data are a good barometer of long-term results. Most procedure-related adverse events in carotid artery intervention occur within this timeframe.”
ANGIOGUARD XP Emboli Capture Guidewire Protection Technology
According to Dr. Yadav, when deployed, the ANGIOGUARD XP Guidewire opens into a tiny protective basket designed to catch plaque particles that may be dislodged during the stenting procedure. “Capturing these particles is important, since embolized plaque may cause stroke,” explained Dr. Yadav, who noted the preliminary success rate for delivering and retrieving the ANGIOGUARD Guidewire was 98%.
Mark Wholey, M.D., SAPPHIRE Trial Investigator, and Chairman of the Pittsburgh Vascular Institute, University of Pittsburgh Medical College Shadyside, explained that more than 60% of the ANGIOGUARD Guidewire baskets contained embolized debris upon their retrieval. “The fact that such a high percentage of the ANGIOGUARD Guidewire baskets contained residual debris indicates that this device provided protection to the study patients, said Dr. Wholey.
Findings for the SAPPHIRE Stent Registry
In addition to the randomized group, the SAPPHIRE study enrolled 409 patients into a stent registry. These were patients who required treatment but were determined by their multidisciplinary treatment team, which included at least one vascular surgeon, to not qualify for CEA. “The 7.8 percent 30-day MAE rate for this group was encouraging given the severity of their disease state,” said Dr. Donohoe.
Carotid Artery Disease and Risk of Stroke
The AHA estimates that 20-30 % of strokes are caused by particles of atherosclerotic plaque, which travel upstream into vessels that supply the brain. The AHA reports that stroke is the most common cause of death and the number one cause of disability in adults. Approximately 730,000 strokes are reported each year in the United States, and approximately 150,000 of these events result in death.
For more than 40 years, Cordis Corporation, a Johnson & Johnson company, has pioneered less invasive treatments for vascular disease. Technological innovation and a deep understanding of the medical marketplace and the needs of patients have made Cordis the world’s leading developer and manufacturer of breakthrough products for interventional medicine, minimally invasive computer-based imaging, and electrophysiology. Today, 5,300 Cordis employees worldwide share a strong commitment to continue the Company’s groundbreaking work in the fight against vascular disease.
# # #
*SAPPHIRE Study: A clinical investigation of Stenting and Angioplasty with Protection in Patients at HIgh Risk for Endarterectomy
† The ANGIOGUARD™ and ANGIOGUARD™ XP Emboli Capture Guidewires are investigational devices limited by federal (U.S.) law to investigational use in the United States.
155-0699-1
