Commonly used carotid stent systems found to be safe

Three common carotid stenting systems used in the U.S. were associated with low rates of adverse events, a study published online Jan. 15 in JACC: Cardiovascular Interventions found.

Jay Giri, MD, MPH, of the University of Pennsylvania’s Perelman School of Medicine in Philadelphia and colleagues evaluated more than 12,000 consecutive carotid artery stenting (CAS) procedures performed between 2007 and 2012 from the National Cardiovascular Data Registry (NCDR) Carotid Artery Revascularization and Endarterectomy (CARE). They compared three different stent/embolic protection device (EPD) combinations—Acculink/Accunet (Abbott Laboratories), Xact/Emboshield (Abbott) and Precise/Angioguard (Cordis Corporation)—in terms of baseline characteristics and the primary outcome of composite stroke and all-cause death while in the hospital.

In 78.2 percent of cases, stents were used with their FDA-approved matching EPD. The Acculink/Accunet was used in 21.6 percent of procedures, the Xact/Emboshield used in 28.9 percent of procedures and the Precise/Angioguard in 22.2 percent of procedures. Before adjustment, analysis found that the Precise/Angioguard system was associated with higher rates of the primary outcome than Acculink/Accunet and Xact/Emboshield (2.5 percent, 1.8 percent and 1.9 percent respectively). Acculink/Accunet and Xact/Emboshield were not significantly different from each other.

However, after adjusted analysis, the three systems were not statistically different. Comparing Precise/Angioguard and Accunet/Acculink, the odds ratio (OR) was 1.48. Comparing Precise/Angioguard and Xact/Emboshield, the OR was 1.16; and comparing Xact/Emboshield and Accunet/Acculink, the OR was 1.28.

The authors argued that their findings suggest that a focus on device characteristics is not likely to affect the rates of adverse events. “Given the known learning curve associated with carotid stenting, operator comfort with individual stenting systems and with case selection is likely of more import in reducing event rates than are technical differences between devices,” they wrote.

In an accompanying editorial, Paul T. Vaitkus, MD, MBA, of Bay Pines Veterans Affairs Medical Center in Bay Pines, Fla. countered that while Giri et al used the NCDR to answer an important clinical question, their analysis was only a safety analysis that lacked long-term outcomes data and did not compare the stents in terms of stroke prevention.

“[W]e lack the full set of considerations to properly compared the 3 stents,” he wrote.