Report from SIR: Diabetics fare well in carotid stenting trial
High-risk diabetic patients who underwent carotid stenting had far fewer heart attacks and significantly fewer major adverse events at one-year follow-up than those who underwent carotid endarterectomy to prevent stroke, according to data presented Friday at the Society of Interventional Radiology meeting in Phoenix.
Out of 310 high-risk patients randomized to either stenting with embolic protection or carotid endarterectomy in the Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) Trial, 86 were diabetic (42 received stents, 44 had endarterectomies).
The 30-day major adverse event rate, which included death, any stroke, or myocardial infarction, was 4.8% for stenting and 22.7% for carotid endarterectomy. The findings were statistically significant, said Dr. Mark H. Wholey, chair of the Pittsburgh Vascular Institute at the University of Pittsburgh Medical Institute.
The one-year major adverse event rate was 16.7% for stenting versus 31.8% for endarterectomy. Incidence of major ipsilateral stroke at 30 days was 2.4% for stenting versus 6.8% for CEA, and at one year, 2.4% for stenteng versus 11.4% for surgery.
At one year, researchers found significant differences for stenting over CEA for rates of myocardial infraction (2.4% vs. 18.2%), major bleeding (4.8% vs. 20.5%), and major adverse events without non-neurologic death (4.8% vs. 25%).
"We thought the initial SAPPHIRE results were exciting. However, these new data from the high-risk diabetic subset shows even more dramatically that stenting is safer than surgery," Wholey said.
The SAPPHIRE trial is the first prospective, multicenter randomized controlled trial to compare carotid stenting with distal protection versus carotid endarterectomy in high-risk patients.
The primary endpoints were the incidence of major adverse events -- i.e., death, any stroke and/or myocardial infarction at 30 days postprocedure -- and a composite of major adverse events plus death and/or ipsilateral stroke between 31 days and one year postprocedure.
The percentage of major adverse events for all subjects in the trial after one year was 12% for stenting and 20.1% for CEA. Seven of 151 patients in the CEA arm suffered cranial nerve injury, while none of the 159 patients randomized to stenting had cranial nerve injury.
The stenting arm had a lower rate of target lesion revascularization (0.6%) compared with CEA (4%).
