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Study investigates outcomes for stent, embolic protection device combinations
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Three particular stent and embolic protection device combinations used for carotid artery stenting accounted for more than 70% of treatment strategies, according to recent findings. These combinations were associated with low adverse event rates.
The researchers aimed to characterize carotid stenting platforms for use and outcomes in a cohort of 12,135 consecutive procedures.
Data were culled from the National Cardiovascular Data Registry and Carotid Artery Revascularization and Endarterectomy registry and included procedures performed between Jan. 1, 2007 and March 31, 2012.
Outcome measures included rates of in-hospital combined death/stroke. The devices under investigation were the Acculink/Accunet (Abbott Laboratories), Xact/Emboshield (Abbott) and Precise/Angioguard (Cordis Corporation) stent/embolic protection device combinations.
More than three-quarters (78.2%) of stents were used with the appropriate FDA-approved corresponding embolic protection device, according to the results. Acculink/Accunet (n=2,617; 21.6%), Xact/Emboshield (n=3,507; 28.9%) and Precise/Angioguard (n=2,696; 22.2%) were the most frequently used combinations, accounting for 72.7% of all cases.
Other devices that underwent analysis included the Protégé/SpiderFx (ev3 Endovascular; n=453; 3.7%) and the Wallstent/Filterwire (Boston Scientific; n=213; 1.8%).
Unadjusted analysis results demonstrated that the Precise/Angioguard system yielded a 2.5% rate of the primary outcome measure compared with 1.8% for Acculink/Accunet (P=.058) and 1.9% for Xact/Emboshield (P=.14). No statistical difference was observed for Precise/Angioguard and Xact/Emboshield.
Adjusted analysis results indicated nonsignificant differences between Precise/Angioguard and Accunet/Acculink (OR=1.48; 95% CI, 0.89-2.47); Precise/Angioguard and Xact/Emboshield (OR=1.16; 95% CI, 0.77-1.76); and Xact/Emboshield and Accunet/Acculink (OR=1.28; 95% CI, 0.82-1.97).
In an accompanying editorial, Paul T. Vaitkus, MD, MBA, of the Cardiology Division of Bay Pines Veterans Affairs Medical Center in Bay Pines, Fla., wrote that the current paper contributes substantially to the literature on the topic.
“First, it provides a broadly representative overview of contemporary [carotid artery stenting] practice in the United States,” he wrote. “Second, the study provides point estimates for the reported complication rates of in-hospital strokes and mortality that can thus serve as benchmarks for quality-assurance programs at local levels as well as guidance for assessing future novel technologies. Last, the paper provides comparative outcomes data for [carotid artery stenting] systems to a degree that exceeds previous efforts, either retrospective or prospective.”
For more information:
Giri J. J Am Coll Cardiol Intv. 2013;doi.org/10.1016/j.jcin.2013.10.014.
Vaitkus PT. J Am Coll Cardiol Intv. 2013;doi.org/10.1016/j.jcin.2013.10.015.
Disclosure: The researchers report relevant financial disclosures with several companies, including Abbott Vascular, Angioguard, Atrium, Becker Ventures, Boston Scientific, Complete Conference Management, Cordis, IDEV Technologies, Lutonix/Bard, Medical Stimulation Corp., Micell, PLC Medical Systems, Silk Road Medical, Viva Physicians, Vortex and W. L. Gore. Vaitkus reports no relevant financial disclosures.