Evaluation of the Medtronic Exponent Self-Expanding Carotid Stent System With the Medtronic Guardwire Temporary Occlusion and Aspiration System in the Treatment of Carotid Stenosis

Higashida, Randall T.; Popma, Jeffrey J.; Apruzzese, Patricia; Zimetbaum, Peter

doi:10.1161/strokeaha.109.564161

Cited by 40 publications

(9 citation statements)

References 34 publications

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“…The greatest benefit for stroke reduction is in patients with recent symptoms of transient ischemic attack or ipsilateral ischemic stroke and severe carotid stenosis (Ͼ70%). Less dramatic benefit exists for asymptomatic patients, for whom other factors such as 47 Other criteria from the ACCULINK for Revascularization of Carotids in High-Risk Patients (ARCHER), 22 Boston Scientific EPI: A Carotid Stenting Trial for High-Risk Surgical Patients (BEACH), 23 Carotid Artery Revascularization Using the Boston Scientific FilterWire EX/EZ and the EndoTex NexStent (CABERNET), 24 Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy (SAPPHIRE), 20 or Medtronic AVE Self-expanding Carotid Stent System With Distal Protection in the Treatment of Carotid Stenosis (MAVERIC II) 25 studies, which are acceptable to CMS as high-risk criteria for reimbursement.…”

Section: Discussionmentioning

confidence: 99%

“…By 3 years, the primary end-point composite estimate remained similar (26.2% versus 30.3%; Pϭ0.71) for CAS versus CEA, including the components of death (20.0% versus 24.2%), ipsilateral stroke (7.4% versus 6.3%), and any stroke (10.1% versus 10.7%). 21 The results from SAPPHIRE, as well as a number of large nonrandomized registry studies, [22][23][24][25] support the use of CAS as an alternative to CEA among patients at higher surgical risk (Table 2).…”

Section: Cea Versus Cas In Patients With Increased Risk For Surgerymentioning

confidence: 92%

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Extracranial Carotid Disease Revascularization

Cutlip

Pinto

2012

Circulation

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E xtracranial carotid artery stenosis is a factor in Ϸ20% to 30% of all strokes. 1,2 Revascularization strategies using surgical carotid endarterectomy (CEA) or carotid artery stenting (CAS) offer the possibility of stroke prevention by restoring flow and mitigating the risk for future plaqueassociated embolization. Numerous studies have assessed whether these procedures reduce the risk for stroke and improve overall clinical outcome, but many issues and questions remain. The available clinical outcome data have highlighted the differential risk and benefit among symptomatic versus asymptomatic patients, the impact of older age and sex, and the surgical risk for CEA related to either anatomic or medical factors. Likewise, the important issues of operator training and experience and refinement of technique for both CEA and CAS affect the interpretation of clinical trial results and the generalization of these results to broader populations of patients and operators. To what extent other cardiovascular outcomes such as myocardial infarction (MI) and cardiac death should be incorporated into the interpretation of specific clinical trials for stroke prevention is also an important consideration. Finally, the lack of data for comparing contemporary medical therapy with revascularization for reduction of stroke and overall cardiovascular outcomes is a serious shortfall. This review assesses the results of historical and more recent clinical trials of the comparative effectiveness of carotid revascularization in the context of these clinical issues.

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Section: Discussionmentioning

confidence: 99%

Section: Cea Versus Cas In Patients With Increased Risk For Surgerymentioning

confidence: 92%

Extracranial Carotid Disease Revascularization

Cutlip

Pinto

2012

Circulation

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“…The primary end point was compared with the published data of 4 US FDA-approved distal EPDs for CAS studies available at the time of the study design (n=1820; historical control; Table 3). [1][2][3][4][5][6] Secondary end points were the components of the primary end point and the various success rates (device, angiographic, procedure, clinical).…”

Section: Study Design and Oversightmentioning

confidence: 99%

“…This dilemma led the EPD evolution toward 2 major directions: the fixed-wire distal protection systems and the proximal protection systems. [1][2][3][4][5] The Wirion Embolic Protection System (EPS) was designed to deploy an independent modular distal filter for embolic protection, using any 0.014″ guidewire, at variable distance from the target lesion.…”

mentioning

confidence: 99%

Independent Modular Filter for Embolic Protection in Carotid Stenting

Scheinert

Reimers

Cremonesi

et al. 2017

Circ: Cardiovascular Interventions

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Background-Embolic protection during carotid artery stenting reduces the rate of thromboembolic events. The Wirion Embolic Protection System is used to deploy an independent distal filter using any 0.014″ guidewire. WISE study (Wirion Study Europe) evaluated the safety and performance of Wirion Embolic Protection System in patients undergoing carotid artery stenting. Methods and Results-A prospective, multicenter, nonrandomized, open-label, single-arm study of carotid artery stenting in high surgical risk patients was performed. The primary end point, a composite of death, stroke, and myocardial infarction at 30 days, was compared with performance goal derived from historical controls. Secondary end points were components of the primary end point and the device, angiographic, procedural, and clinical success rates. Preplanned interim analysis was performed on the first 120 patients. At interim analysis, the primary end point was significantly lower for the Wirion Embolic Protection System group, compared with historical data (3.3% versus 6.3%, respectively; P value =0.0008). Analysis of primary end point components in the WISE group, compared with the historical control group, shows numerically lower mortality (0% versus 1.7%, respectively; P=0.21), stroke (2.5% versus 4.6%, respectively; P=0.18), and myocardial infarction (0.8% versus 1.5%, respectively; P=0.50). Device, angiographic, procedural, and clinical success was achieved in 99.2%, 99.1%, 98.3%, and 96.6% of cases, respectively. Conclusions-The data suggest that independent modular filter use in carotid artery stenting in high surgical risk patients is safe and effective. The outcomes suggest that use of an independent modular filter may be associated with a lower rate of embolic complications associated with carotid stent placement. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01783639.

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“…Since patients had unrestricted access to carotid endarterectomy (CEA), a proven surgical option with low expected morbidity and mortality, initial investigations in CAS were undertaken in patients with comorbid conditions and/or anatomical features that increased the risk of adverse events (AEs) during CEA. In the past decade, the US Food and Drug Administration (FDA) approved all stent systems studied for an indication of CAS revascularization in these high-surgical-risk patients, based on both randomized controlled and singlearm clinical investigational device exemption (IDE) trials conducted during that period [1][2][3][4][5][6][7][8].…”

Section: Introductionmentioning

confidence: 99%

The impact of regulatory approval and Medicare coverage on outcomes of carotid stenting

Gray

Verta

2013

Cathet Cardio Intervent

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Background Carotid artery stenting (CAS) was introduced in the United States nearly a decade ago as a novel treatment of severe carotid stenosis. Voluminous and high‐quality prospective data permit analysis of longitudinal trends in CAS outcomes. Methods Outcomes from all prospective trials with the Food and Drug Administration (FDA) oversight from 2000–2011 were reviewed, as were the subset of studies using a single CAS system. All studies shared common inclusion/exclusion criteria, endpoints, independent assessment/adjudication of neurological events, and were conducted in accordance with FDA regulations. Death and stroke (DS) rates from FDA‐approved studies in high‐surgical‐risk patients were assessed. Results Between 2000 and 2011, two distinct periods with clustered and differentiated outcomes in CAS IDE trials were observed, separated by FDA approval and Centers for Medicare and Medicaid Services (CMS) coverage in 2004–2005. The mean 30‐day DS rate in the first wave (2000–2004) of CAS trials was 5.3% (95% CI: 4.6–6.2%), and fell significantly to 2.6% (95% CI: 1.9–3.7%; P = 0.0001) in the second wave (2006–2011). This decline occurred during a simultaneous, independent 24‐fold increase in monitored CAS activity. This decline in DS rates was observed in symptomatic and asymptomatic patients, alike independent of device tested. Conclusions Declines in periprocedural DS rates in CAS appear linked to regulatory and coverage approvals leading to increased operator experience along with continued regulatory oversight, and provide insight into the introduction of other novel therapies. © 2013 Wiley Periodicals, Inc.

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Evaluation of the Medtronic Exponent Self-Expanding Carotid Stent System With the Medtronic Guardwire Temporary Occlusion and Aspiration System in the Treatment of Carotid Stenosis

Cited by 40 publications

References 34 publications

Extracranial Carotid Disease Revascularization

Extracranial Carotid Disease Revascularization

Independent Modular Filter for Embolic Protection in Carotid Stenting

The impact of regulatory approval and Medicare coverage on outcomes of carotid stenting

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