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.”