Researchers report that a recent clinical trial designed for stroke prevention titled PROTECT (Cartoid Artery Stenting with Distal Embolic Protection with Improved System) has reportedly the lowest rate of complications in patients at high risk for carotid endarterectomy (CEA).
Jon Matsumra, MD, head of the vascular surgery division at University of Wisconsin School of Medicine and Public Health, headquartered in Madison, Wis, led the study. “Recent improvements in devices designed specifically for carotid artery stenting have resulted in safer procedures and better clinical outcomes,” Matsumra reports.
According to a recent news release, the PROTECT study was a prospective, multi-center clinical trial. The study reportedly sought to investigate the safety of Emboshield Pro, an embolic protection device used in tandem with stenting to assist in enlarging the blocked artery and capturing any plaque potentially dislodged in the process.
Researchers say the study encompassed 322 patients with carotid artery stenosis at 38 centers across the US between 2006 and 2008. Study results indicate the first 220 patients were treated with a stent and Emboshield Pro. The 102 remaining patients received a stent and an older, now obsolete embolic protection device called Emboshield BareWire. Researchers report that they followed patient outcome, including death, stroke, or myocardial infraction (DSMI) 30 days post procedure. Among the 220 study participants treated with Emboshield Pro, study results suggest that three patients suffered a minor stoke, one a major stroke, and one a DSMI. Results go on to indicate that the overall DSMI rate was at 2%, reportedly the lowest rate of complications recorded for the procedure in similar multicenter high-risk patient populations.
Matsumra explains that the research correlates with trends in other trials, in which complication rates have been reduced for patients treated with stents and embolic protection devices. He adds that the results offer potentially good news and more options for high-risk patients suffering from carotid artery disease.
Source: University of Wisconsin-Madison