SAPPHIRE and CABANA Add More Validation for Carotid Artery Stenting

SAN FRANCISCO, CALIF.—Carotid artery stenting remains a practical alternative to carotid endarterectomy in patients at average- or high-risk for surgery, according to new data from the SAPPHIRE and CABANA trials presented at TCT. The presenters said with adequate training and experience, new-generation stents are proving safe and effective in routine clinical practice.

SAPPHIRE

One-year results of over 7,000 patients from the SAPPHIRE Worldwide study confirm that carotid artery stenting is associated with a low risk for stroke and a low rate of target vessel revascularization. Data were presented by D. Christopher Metzger, MD, director of the cardiac cath lab, and medical director of Clinical Research at Wellmont CVA Heart Institute in Tennessee.

The rate of all major adverse events was 4.6% at 30 days. At 360 days, incidence rates were: 10.7% for all major adverse events, 4.6% for any stroke and 0.2% for TVR.

Symptom status, age and high-risk entry criteria had a significant effect on both peri-procedural and 1-year outcomes, with symptomatic patients, elderly patients and physiologic risk resulting in higher incidence rates at both time points, Metzger said (see Table).

Dr. Metzger said one finding in particular was surprising to him. “[When] looking at male and female patients, there was no significant difference between men and women and, if anything, there was a very surprising trend toward fewer events in women compared to men that was not completely consistent with prior studies.”

SAPPHIRE Worldwide will continue to make clinical evidence available to optimize patient selection for treatment with carotid artery stenting, he said.

CABANA

Given the results of randomized clinical trials like SAPPHIRE, and long-term safety and efficacy data on the Carotid Wallstent (Boston Scientific) used with the FilterWire EZ (Boston Scientific) in the BEACH trial, the CABANA Safety Surveillance study was undertaken to determine whether stenting with this device is safe and effective in routine clinical practice by looking at operator training and center experience.

According to L. Nelson Hopkins, MD, of the Gates Vascular Center at the University of Buffalo in New York, the most severe adverse events recorded were strokes and were consistent with rates seen in other high-enrolling carotid artery stenting registries. The rate of all major adverse events was 4.6%.

The study included 1,097 patients at high risk for surgery (anatomic risk, n=375 or co-morbid risk, n=550) who underwent carotid artery stenting at 99 centers in the United States with the Carotid Wallstent and the FilterWire EZ. The centers had a broad spectrum of operators, and mandatory training was required for those without adequate experience. The primary endpoint was the composite rate of death, stroke and MI less than 30 days post-procedure.

“Looking at major adverse events by center experience and operator experience, the bottom line is that there was maybe a slight trend favoring more experienced operators, but no significant difference across the board,” Hopkins said. “That basically says, in simple terms, that with adequate training experience, and if you learn how to use the device, you can get pretty good results across the board in these high-risk patients, whether you’re a very experienced operator or learning in a good teaching program before you start the procedure.”

Most strokes were ipsilateral and ischemic, and slightly more than half were major.

“The whole study shows that the Carotid Wallstent and FilterWire EZ is a safe and effective treatment option for patients with carotid artery stenosis who are at high risk for surgery,” he said. “It also shows that stenting, in general, is a safe alternative to CEA for patients with high surgical risks.”

Additional study details

SAPPHIRE was a multicenter, prospective study of 7,073 patients with an average age of 72.4 years at high-risk for adverse events from carotid endarterectomy. The primary endpoint was major adverse events, including death, MI or stroke up to 30 days after revascularization.