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Objectives: The aim of this study was to compare the stroke/death rates between proximal embolic protection devices (P-EPDs) and distal filter embolic protection devices (F-EPDs) in elective carotid artery stenting (CAS)., Background: P-EPDs have theoretical advantages that may make them superior to F-EPDs for stroke prevention during CAS., Methods: We examined 10,246 consecutive elective CAS procedures performed with embolic protection in the NCDR CARE registry between January 2009 and March 2013. We analyzed crude and propensity-matched rates of in-hospital combined death/stroke in patients treated with P-EPDs versus F-EPDs. Secondary analyses included 30-day adverse event rates and stroke rates by the involved cerebrovascular territory., Results: P-EPDs were used in 590 of 10,246 cases (5.8%). Patients treated with P-EPDs had higher rates of symptomatic lesion status (46.8% vs. 39.7%, p<0.001), atrial fibrillation/flutter (16.1% vs. 13.0%, p=0.03), and history of a neurological event (51.2% vs. 46.6%, p=0.03). In unadjusted and propensity-matched analyses, differences in in-hospital stroke/death between P-EPD and F-EPD cohorts were nonsignificant (1.5% vs. 2.4%, p=0.16 and 1.6% vs. 2.0%, p=0.56, respectively). For patients with available data (n=7,693, 75.1%), 30-day adverse events rates were similar for P-EPDs and F-EPDs before (2.5% vs. 4.2%, p=0.07) and after (2.7% vs. 4.0%, p=0.22) propensity matching., Conclusions: Use of a P-EPD during CAS was associated with low rates of in-hospital stroke/death similar to those with an F-EPD in the first comparative effectiveness study of the devices. An adequately powered randomized trial comparing clinical outcomes between these devices is unlikely to be feasible., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Given the controversy regarding whether carotid endarterectomy (CEA) or carotid artery stenting (CAS) may be superior for stroke prevention, it is uncertain how recent clinical evidence, guidelines, and reimbursement policies have influenced the volume and outcomes after these procedures., Methods and Results: We conducted a serial, cross-sectional study with time trends of patients undergoing CAS (n=124 265) and CEA (n=1 260 647) between 2001 and 2010 from the Nationwide Inpatient Sample database. During the 10-year period, the frequency of CEA declined, whereas CAS use slowly increased. After multivariate propensity score-matched analysis, CAS was associated with an increased risk of death (odds ratio [OR], 1.69; 95% confidence interval [CI], 1.40-2.04), stroke (OR, 1.43; 95% CI, 1.23-1.66), and major adverse events including death, stroke, and myocardial infarction (OR, 1.25; 95% CI, 1.13-1.39). In asymptomatic patients, there was no significant difference in major adverse events (OR, 1.08; 95% CI, 0.92-1.20; P=0.16 [P <0.001 for interaction between procedure type and symptom status]) between CAS and CEA. Importantly, there was a significant improvement in CAS outcomes during the course of 10 years (reduction in death [OR, 0.51; 95% CI, 0.49-0.67; P for trend=0.03] and major adverse events [OR, 0.75; 95% CI, 0.66-0.84; P for trend=0.05] comparing years 2010 versus 2001)., Conclusions: In US hospitals between 2001 and 2010, CAS was associated with worse in-hospital outcomes, partly attributable to selection and ascertainment bias. Asymptomatic patients undergoing CAS versus CEA had similar adjusted rates of major adverse events. CAS outcomes improved significantly during the course of the decade likely attributable to improvements in patient selection, operator skills, and technological advancements., (© 2014 American Heart Association, Inc.)

Objectives: This study sought to characterize usage and outcomes of carotid stenting platforms., Background: A variety of stents and embolic protection devices (EPDs) are used for carotid artery stenting. Little is known about current usage patterns and differences in outcomes with these devices., Methods: We analyzed 12,135 consecutive carotid stent procedures in the NCDR (National Cardiovascular Data Registry) CARE (Carotid Artery Revascularization and Endarterectomy) registry performed between January 1, 2007 and March 31, 2012. We compared baseline characteristics and crude and multivariable-adjusted rates of in-hospital combined death/stroke among patients treated with Acculink/Accunet (Abbott Laboratories, Abbott Park, Illinois), Xact/Emboshield (Abbott), and Precise/Angioguard (Cordis Corporation, Bridgewater, New Jersey) stent/EPD combinations., Results: In 78.2% of cases, stents were used in conjunction with their specific, corresponding U.S. Food and Drug Administration-approved EPD. The Acculink/Accunet (n = 2,617, 21.6%), Xact/Emboshield (n = 3,507, 28.9%), and Precise/Angioguard (n = 2,696, 22.2%) stent/EPD combinations were used in 72.7% of all cases. The Protégé/SpiderFx (ev3 Endovascular Inc., Plymouth, Minnesota) (n = 453, 3.7%) and Wallstent/Filterwire (Boston Scientific, Natick, Massachusetts) (n = 213, 1.8%) devices were used in a minority of cases. In unadjusted analyses, the Precise/Angioguard system was associated with higher rates of the primary outcome than were the Acculink/Accunet (2.5% vs. 1.8%; p = 0.058) and Xact/Emboshield (2.5% vs. 1.9%; p = 0.14) systems that were not statistically different. In adjusted analyses, differences between Precise/Angioguard and Accunet/Acculink (odds ratio [OR]: 1.48, 95% confidence interval [CI]: 0.89 to 2.47; p = 0.065), Precise/Angioguard and Xact/Emboshield (OR: 1.16, 95% CI: 0.77 to 1.76; p = 0.38), and Xact/Emboshield and Accunet/Acculink (OR: 1.28, 95% CI: 0.82 to 1.97; p = 0.18) remained nonsignificant., Conclusions: In modern U.S. practice, the Acculink/Accunet, Xact/Emboshield, and Precise/Angioguard carotid stenting systems are used in most cases and are associated with similarly low rates of adverse events., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objective: The multicenter EPIC (FiberNet Embolic Protection System in Carotid Artery Stenting Trial) single-arm trial evaluated the 30-day outcomes of a new design concept for embolic protection during carotid artery stenting (CAS)., Background: Embolic protection filters available for use during CAS include fixed and over-the-wire systems that rely on embolic material capture within a "basket" structure. The FiberNet Embolic Protection System (EPS), which features a very low crossing profile, consists of a three-dimensional fiber-based filter distally mounted on a 0.014 inch guidewire with integrated aspiration during filter retrieval., Methods: The trial enrolled 237 patients from 26 centers. Demographics, clinical and lesion characteristics, as well as adverse events through a 30-day follow-up were recorded. The mean age of the patients was 74 years, 64% were male and 20% had symptomatic carotid artery disease., Results: The combined major adverse event (MAE) rate at 30 days for all death, stroke, and myocardial infarction was 3.0%. There were three major strokes (two ischemic and one hemorrhagic) and two minor strokes (both ischemic) for a 2.1% 30-day stroke rate. The procedural technical success rate was 97.5% and macroscopic evidence of debris was reported in 90.9% of the procedures., Conclusions: The FiberNet EPS, used with commercially available stents, produced low stroke rates following CAS in high surgical risk patients presenting with carotid artery disease. The unique filter design including aspiration during retrieval may have contributed to the low 30-day stroke rate reported during CAS in patients considered at high risk for complications following carotid endarterectomy (CEA)., (Copyright 2010 Wiley-Liss, Inc.)

Stroke is the third leading cause of death in the United States. Carotid artery stenosis represents one of the most common etiologies of stroke. The current treatment modalities available for the treatment of carotid artery stenosis are carotid endarterectomy (CEA) and carotid artery stenting (CAS). Several clinical trials comparing CEA with medical management showed superiority of the surgical arm; however, the applicability of these results to the general population is limited by the fact that the patients and surgeons enrolled in these trials were carefully selected, and the optimal medical therapy used does not meet the current treatment standards. Carotid artery stenting has emerged as a treatment alternative to CEA, as shown in randomized trials comparing the 2 treatment modalities. Recent data from large-volume CAS registries indicate that percutaneous treatment of carotid artery stenosis compares favorably to CEA. Furthermore, the CAS trial designs make these results more applicable to the community standards. These data suggest that CAS will become the treatment of choice in patients with carotid artery stenosis.