Carotid artery stenting is an attractive concept for the treatment of patients with significant carotid stenoses who were at higher risk for carotid endarterectomy, but stroke rates in initial studies were unacceptably high. New stent deployment systems have been developed with downstream protection devices that catch debris caused by stent deployment. Thus, SAPPHIRE (Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy) was designed to test the hypothesis that patients with significant carotid stenoses who were at high risk for surgical endarterectomy would have better perioperative outcomes using stenting with distal protection. High risk was defined as heart failure, severe chronic obstructive pulmonary disease, previous carotid endarterectomy, severe coronary artery disease, previous radical neck surgery, and radiation therapy. Symptomatic patients with greater than 50% stenosis of a common or internal carotid artery and asymptomatic patients with greater than 80% stenosis were evaluated by a team, including a surgeon, a cardiologist, and a neurologist. A consensus was required to randomize the patients. If the surgeon believed that surgery was inordinately risky, then the patients were entered into a stent registry, which consisted of 408 patients. Randomization was accomplished in 307. The primary end point was death, stroke, or myocardial infarction (MI) adjudicated at 30 days.
Stented patients got ASA and Plavix; surgery patients got only ASA, due to bleeding risk. The results in the randomized patient are shown in the Table.
In the stent registry patients, the primary event rate was 7.8%. The authors concluded that stenting with distal protection of significant carotid stenoses in high-risk surgical patients is superior to surgery with regard to 30-day major adverse events.
(P = .047)
Comment by Michael H. Crawford, MD
This is the first prospective multicentered, randomized, controlled study of patients at high risk for surgery treated with a new distal protection stenting device. A unique feature of the study was the inclusion of MI as end point. This is important because CAD patients frequently have vascular disease in other organs. In fact, in this study MI was the most-frequent major adverse event in the surgical group and undoubtedly accounted for most of the increased mortality seen in this group. Stroke rates were similar in both groups. The centers picked for this study were those with a large amount of experience and low complication rates and there was a high technical success rate in both arms. Outcomes in other centers may not be as good. Also, the patients at too high a risk for surgery who were entered in the stent registry had a higher event rate (7.8% vs 5.8%). Thus, high-risk surgical patients are also higher-risk percutaneous intervention patients. This raises the issue of who will be interested in performing these procedures with a 3% stroke risk, a 3% MI risk, and a 0.5% death risk in the best of hands. Surgeons live with this magnitude of risk daily, but many interventionalists do not. I believe many will await the 1-year results before jumping into the fray.
Dr. Crawford is Professor of Medicine, Mayo Medical School; Consultant in Cardiovascular Diseases, and Director of Research, Mayo Clinic, Scottsdale, AZ.