NCDR Study Examines the Effectiveness of Commonly Used Devices for CAS

For many years carotid artery stenting (CAS) has served as a commonly used revascularization procedure to reduce the risk of stroke among patients with asymptomatic or symptomatic carotid stenosis. While a variety of stents and embolic protection devices (EPDs) are used for CAS, little is known about their usage patterns and the comparative effectiveness of these devices. A new study, published Jan. 15 in JACC: Cardiovascular Interventions, sought to successfully characterize these unknowns, and found that there are low complication rates among CAS procedures.

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Analyzing over 12,000 consecutive CAS procedures in the NCDR's CARE Registry performed between Jan. 1, 2007 and March 31, 2012, researchers led by Jay Giri, MD, MPH, Cardiovascular Medicine Division, University of Pennsylvania Perelman School of Medicine, compared the baseline characteristics and multivariable-adjusted rates of in-hospital combined stroke-related deaths among patients treated with stent/EPD combinations.

The resulting data showed that the Acculink/Accunet, Xact/Emboshield, and Precise/Angioguard stent/EPD combinations were used in 72.7 percent of all cases, with their implementation evenly divided between them. Others such as the Protégé/SpiderFx and Wallstent/Filterwire devices were used in an extreme minority of cases. In the cases of Acculink/Accunet, Xact/Emboshield, and Precise/Angioguard, data also showed that 78.2 percent of the time they were used in conjunction with their specific, corresponding U.S. Food and Drug Administration-approved EPD.

While Giri and his team never explicitly revealed an overall complication rate, calculating the in-hospital mortality and stroke rates for the cohort as a whole were only .35 percent and 1.8 percent respectively, with the 30-day mortality and stroke rates approximately .73 percent and 3.2 percent, demonstrating that the real-world practice of CAS measured favorably to what was posited in previous clinical trials and registries.

"Whereas [cost and coverage] are the principal domains for policy-makers and payers, clinical providers are concerned with a somewhat more parochial issue," writes Paul T. Vaitkus, MD, MBA, FACC, in an editorial comment. He notes that the current study "provides several substantive contributions to the literature," and adds that moving forward, "comparative effectiveness research is a theme that will play an increasingly important role in the discourse of medical care."

Keywords: Registries, Embolic Protection Devices, United States Food and Drug Administration, Comparative Effectiveness Research, Carotid Stenosis

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