Periprocedural Data Presented for 21,008 CAS Patients in Cordis' SAPPHIRE Worldwide Postapproval Registry

November 3, 2015—SAPPHIRE Worldwide is the largest prospective, multicenter, postapproval study to evaluate carotid artery stenting (CAS). SAPPHIRE Worldwide compared CAS and angioplasty with protection in patients at high risk for carotid endarterectomy. The study enrolled 21,008 patients who received CAS with distal embolic protection using the Precise nitinol stent (Cordis Corporation) and Angioguard XP/RX emboli capture guidewire (Cordis Corporation).

During the second of two Late-Breaking Trials sessions at VIVA 15, the 13th annual Vascular InterVentional Advances meeting, D. Christopher Metzger, MD, presented the periprocedural outcomes of all 21,008 CAS patients treated with the Precise device in SAPPHIRE Worldwide. The meeting, which is sponsored by VIVA Physicians, Inc., is being held November 2–5, 2015, at the Wynn Las Vegas in Las Vegas, Nevada. The session moderators are Michael R. Jaff, DO, and Krishna Rocha-Singh, MD.

As summarized by VIVA, the primary objective of the multicenter, prospective SAPPHIRE Worldwide postapproval registry is to evaluate 30-day major adverse events after CAS performed by physicians with varied experience. All patients had prospective independent neurologic and cardiac enzyme assessment.

The 21,008 patients were enrolled from October 2006 to May 2014, with adjudicated data at 30-day follow-up. Patients’ mean age was 72.3 ± 9.52 years, 61.4% were men, and 30.1% were symptomatic. Entry criteria for surgical high-risk patients included pure anatomic (n = 7,667) and pure physiologic (n = 8,216) risk factors.

At 30-day follow-up, the major adverse events rate was 4.4% (death, 1.2%; stroke, 3.3%; myocardial infarction, 0.5%) for the overall population. Patients who were elderly, symptomatic, or had physiologic high risk had more events with CAS; gender did not influence outcomes.

Noting that SAPPHIRE Worldwide is the largest prospective trial of CAS patients to date and is performed in a real-world setting with prospective neurologic and cardiac evaluation, Dr. Metzger concluded that these results are consistent with results of the CREST trial and other large registries; they add further validation for CAS and provide important data regarding optimal patient selection for this procedure.