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Stenting and Angioplasty with Protection in Patients at High-Risk for Endarterectomy: First 2,000 Patients from the SAPPHIRE Worldwide Registry 

Doug Massop¹, Rajesh M. Dave², Christopher Metzger³, William Bachinsky⁴, Maurice Solis⁵, Rasesh Shah⁶, Greg Schultz⁷, Theodore Schreiber⁸, Majdi Ashchi⁹, Robert Hibbard¹⁰, and Amy Orlick¹¹ for the SAPPHIRE Worldwide Investigators.
¹The Iowa Clinic, Des Moines, IA;²Central PA CV Research Institute, Harrisburg, PA;³Holston Valley Medical Center, Kingsport, TN;⁴Pinnacle Health at Harrisburg, Harrisburg, PA;⁵Medical Center of Central Georgia, Macon, GA;⁶Sentara Norfolk General Hospital, Norfolk, VA;⁷Sioux Valley Clinic, Sioux Falls, SD;⁸Harper University Hospital, Detroit, MI;⁹Memorial Medical Center, Jacksonville, FL;¹⁰Bruan LGH Heart Institute, Lincoln, NE;¹¹Cordis Corporation, Warren, NJ

Objectives: Previously, the SAPPHIRE (Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy) prospective, randomized study showed that carotid artery stenting (CAS) was not inferior to carotid endarterectomy (CEA) in the treatment of high-surgical risk patients. The primary objective of this study is to evaluate 30-day major adverse event rate (death, stroke or MI) after CAS performed at high, medium and low volume centers by physicians with varied experience and utilizing a formal training program.
Methods: SAPPHIRE Worldwide is a multicenter, prospective, post-approval study to evaluate CAS with distal emboli protection in patients with atherosclerotic carotid disease at high-risk for surgery using the Cordis PRECISE® Nitinol Stent and ANGIOGUARD XP/RX Emboli Capture Guidewire. Participating physicians are encouraged to treat patients according to their standard of practice and consistent with current FDA-approved labeling. Clinical follow-up is planned at 30 days. Major adverse events (MAE), including death, stroke, myocardial infarction, target vessel revascularization, and stent thrombosis will be assessed out to12 months.
Results: Enrollment began October, 2006. A total of 2,002 patients at 216 centers have completed 30-day follow-up and preliminary data are available on these patients. The mean age was 72.1  10.1 years, 62.0% were male, 27.6% were symptomatic and 72.3% were asymptomatic. Entry criteria for surgical high-risk included anatomic (n=730), physiological (n=988) or both risk factors (n=284). At 30-day follow-up, MAE was 3.2% (death 0.7%, stroke 2.4%, MI 0.5%) for the overall population. Although not statistically significant, patients with anatomic risk factors had a lower rate of 30-day MAE than patients with physiological risk factors (2.3% vs. 3.7%, p=0.1232), respectively. Patients with previous CEA recurrent stenosis (n=442) had an MAE rate of 2.0%.
Conclusions: Results from the SAPPHIRE Worldwide Registry will continue to provide evidence in support of optimal patient selection, lesion criteria, and operator experience in performing carotid stenting in this high-surgical risk group of patients. Final and adjudicated data will be available at time of presentation.

Disclosure Block:
D. Massop, Consulting Fees; R. Dave, None; C. Metzger, None; W. Bachinsky, None; M. Solis, None; R. Shah, None; G. Schultz, None; T. Schreiber, None; M. Ashchi, None; R. Hibbard, None; A. Orlick, Full-time Employee.