Carotid Stenting Safe for Patients at High Risk for Surgery

Key Points:

• SAPPHIRE World Wide registry supports carotid artery stenting as alternative to endarterectomy.

By TCT Daily Staff

In the SAPPHIRE World Wide carotid artery stenting registry, the rate of major adverse events was 4.4%, which compared favorably with a 4.8% rate in the SAPPHIRE randomized trial, and a rate of 5% in the CASES-PMS trial.

D. Chris Metzger, MD, director of cardiac and peripheral cath labs, medical director of clinical research at Wellmont Hoiston Valley Medical Center in Kingsport, Tenn., presented results of the first 2,001 patients enrolled in the multicenter, prospective, post-approval registry.

The researchers evaluated outcomes after carotid artery stenting with the Cordis Precise Nitinol Stent and Angioguard XP/RX Emboli Capture Guidewire System. The registry included data from 216 centers; 26% of the patients were older than 80 years and 27.7% were symptomatic.

Study endpoints included major adverse events such as death, MI, or stroke up to 30 days after the procedure. Death occurred in 1.1% of patients, MI in 0.7%, and stroke in 3.2%, according to Metzger. Compared with the SAPPHIRE randomized trial and CASES-PMS trial, patients in the registry had decreased major adverse events at 30 days.

"Contralateral strokes were minimal compared to what has been previously reported, demonstrating an improvement in technique," Metzger said. Stroke or death occurred in 2.5% of those with anatomic risk and 4.5% of those with physiological risk (P=.0443).

Major adverse event rates at 30 days were significantly lower in asymptomatic patients (n=1,446) compared with symptomatic patients (n=555) (33% vs. 7%; P=.0005), according to Metzger. In addition, death occurred in 0.8% of asymptomatic patients vs. 2% of symptomatic (P=.0286); MI, 0.6% of asymptomatic patients vs. 0.9% symptomatic (P=ns); stroke, 2.4% of asymptomatic patients vs. 5.4% symptomatic (P=.0010); stroke or death, 2.9% of asymptomat