Bridgewater, New Jersey – October 23, 2012 – Cordis Corporation today announced the presentation of the SAPPHIRE study results for the first 15,000 patients at the TCT 2012 conference in Miami.
SAPPHIRE (STENTING AND ANGIOPLASTY WITH PROTECTION IN PATIENTS AT HIGH-RISK FOR ENDARTERECTOMY) World Wide (SWW) Registry is one of the largest carotid artery stenting (CAS) studies to date with more than 15,000 patients undergoing CAS with cerebral protection. It is a multicenter, prospective study to evaluate the outcomes of CAS using the PRECISE® Nitinol Stent and ANGIOGUARD® XP/RX Emboli Capture Guidewire System in the treatment of obstructive carotid artery disease. The peri-procedural results were presented by Christopher Metzger, MD, National Co-Principal Investigator of the study.
“Cordis is committed to providing clinically relevant data on the optimal treatment strategies for carotid revascularization,” said Shlomi Nachman, Worldwide President, Cordis Corporation. “We are pleased with the results of SAPPHIRE and look forward to additional data as more patients are enrolled.”
Enrollment began October, 2006 and is ongoing. Data were reported on 15,003 patients, of whom 4,569 (30%) were symptomatic and 10,433 (70%) were asymptomatic. Overall, the MAE rate at 30 days was 4.5% (death 1.2%, MI 0.6%, stroke 3.3%). There was a significant difference in the combined rate of stroke or death at 30 days between symptomatic (5.6%) and asymptomatic (3.5%) patients (p<0.0001), and patients 75 years of age and older (5.6%) compared to younger (2.9%) patients (p<0.0001).
“We are pleased with the results which continue to demonstrate favorable clinical outcomes for carotid stenting consistent with earlier findings in this study at previous lower sample sizes,” said Hans-Peter Stoll, MD, Vice President World-Wide Clinical Research & Medical Affairs, Cordis Corporation. “This data compares favorably to other reports of CAS in a high-surgical risk population and is similar to results reported in the CREST trial comparing CAS to surgery in a non-high surgical risk population.”
Patients who are at high-risk for adverse events from the carotid endarterectomy procedure were included in this study. This would then include symptomatic patients with > 50% or asymptomatic patients with > 80% stenosis in their carotid artery. The primary endpoints for the study are major adverse events which include death, any myocardial infarction or stroke up to 30 days after the stenting procedure. Secondary outcomes such as the effect of symptom status, age, gender and high risk entry criteria were also analyzed.
Dr. Metzger is compensated for his services as a consultant to Cordis Corporation.
About Cordis Corporation
Cordis Corporation, part of the Johnson & Johnson family of companies, is a worldwide leader in the development and manufacture of interventional vascular technology. Through the company's innovation, research and development, Cordis partners with interventional cardiologists worldwide to treat millions of patients who suffer from vascular disease. More information about Cordis Corporation can be found at www.cordis.com.