Contemporary Carotid Stenting Practice Associated With Low Adverse Event Rates

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In the United States, carotid artery stenting (CAS) for symptomatic and asymptomatic disease is associated with low adverse event rates across a wide range of institutions using 3 specific stent/embolic protection device systems, according to a registry study published online January 15, 2014, ahead of print in JACC: Cardiovascular Interventions.

Jay Giri, MD, of the Hospital of the University of Pennsylvania (Philadelphia, PA), and colleagues analyzed data from the National Cardiovascular Database Registry (NCDR) on 12,135 consecutive CAS procedures conducted between January 2007 and March 2012. The following stent and embolic protection device systems were used (with “other” making up 22% of the cases):

• Xact/Emboshield (Abbott Laboratories, Abbott Park, IL; n = 3,507)
• Precise/Angioguard (Cordis Corporation; Bridgewater; NJ; n = 2,696)
• Acculink/Accunet (Abbott; n = 2,617)
• Protégé/SpiderFx (ev3 Endovascular, Plymouth, MN; n = 453)
• Wallstent/Filterwire (Boston Scientific, Natick, MA; n = 213)

The majority of patients (72.7%) were treated with the Xact, Precise, or Acculink systems. Additionally, stents were used in conjunction with their US Food and Drug Administration (FDA)-approved embolic protection device in 78.2% of cases.

In unadjusted analyses, the Precise/Angioguard system was associated with a trend toward higher in-hospital death or stroke (primary outcome) compared with both the Acculink/Accunet (P = 0.058) and the Xact/Emboshield (P = 0.14). However, there was no difference in this outcome between Acculink/Accunet and Xact/Emboshield (P = 0.63). Higher rates of stroke were seen with the Precise/Angioguard system compared with Xact/Emboshield (P = 0.02), while the former trended higher than the Acculink/Accunet system (P = 0.06; table 1).

Table 1. Unadjusted Rates of In-Hospital Adverse Events by Carotid Stenting System

 
Analyses adjusted for baseline characteristics maintained these results, with no differences seen between the 3 most commonly used systems in regard to the primary outcome (table 2).

Table 2. Adjusted Risk of the Primary Outcome Between Systems

 
Thirty-day outcomes, available in 78% of the cohort, were similar to in-hospital event rates with a trend toward increased stroke/death risk with the Precise/Angioguard system.

Questioning the Systems

The study confirms that, for the most part, physicians are using stents with their proper FDA-recommended embolic protection device, Dr. Giri and colleagues write. Reasons for this may include operator comfort, reimbursement restrictions, and ongoing post-market surveillance. However, they add that “it is possible that a strategy of selecting carotid stents and [embolic protection devices] individually according to procedural characteristics might benefit operators and patients.”

Moreover, the authors liken the current usage pattern to “a situation in which coronary interventional operators could only use a single wire with a matching stent as opposed to choosing stents and wires independently of one another, each optimally suited for the particular anatomical situation encountered.”

A limitation of the study, the authors say, was the lack of separate assessment of outcome effects that could have been linked with the individual stents or embolic protection devices.

“Our study suggests that a continued focus on stent and distal filter [embolic protection device] characteristics is not likely to lead to dramatically improved event rates, and efforts at periprocedural stroke reduction can focus elsewhere,” they conclude. “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.”

‘Substantive Contributions’

In an editorial accompanying the study, Paul T. Vaitkus, MD, MBA, of the Bay Pines Veterans Affairs Medical Center (Bay Pines, FL), reports the “paper provides several substantive contributions to the literature,” including:

• A “broadly representative overview” of US CAS use
• Point estimates for in-hospital complication rates that can “serve as benchmarks for quality-assurance programs . . . and guidance for assessing future novel technologies”
• Comparative outcomes data “to a degree that exceeds previous efforts”

Dr. Vaitkus observes that the complication rates found in the study were “reasonably low,” but comments that the paper never explicitly states an overall complication rate. Even so, “real-world practice of CAS thus measures favorably to what was demonstrated in pivotal clinical trials and previous registries,” he writes.

 

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Sources:
1. Giri J, Kennedy KF, Weinberg I, et al. Comparative effectiveness of commonly used devices for carotid artery stenting: An NCDR (National Cardiovascular Data Registry) analysis. J Am Coll Cardiol Intv. 2014;Epub ahead of print.

2. Vaitkus PT. Contemporary carotid stenting: Comparative effectiveness research from the NCDR (National Cardiovascular Data Registry). J Am Coll Cardiol Intv. 2014;Epub ahead of print.

 

 

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