Elsevier

JACC: Cardiovascular Interventions

Volume 13, Issue 18, 28 September 2020, Pages 2170-2177
JACC: Cardiovascular Interventions

Peripheral
1-Month Results From a Prospective Experience on CAS Using CGuard Stent System: The IRONGUARD 2 Study

https://doi.org/10.1016/j.jcin.2020.05.026Get rights and content
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Abstract

Objectives

This study sought to evaluate 30-day safety and efficacy of dual-layer mesh-covered carotid stent systems for carotid artery stenting (CAS) in the clinical practice.

Background

When compared with carotid endarterectomy, CAS has been associated with a higher rate of post procedural neurologic events; these could be related to plaque’s debris prolapsing through stent’s mesh. Consequently, the need for increased plaque coverage has resulted in the development of dual-layer mesh-covered carotid stent systems.

Methods

From January 2017 to June 2019, a physician-initiated, prospective, multispecialty registry enrolled 733 consecutive patients undergoing CAS using the CGuard embolic prevention system in 20 centers. The primary endpoint was stroke up to 30 days; secondary endpoints were technical and procedural success; external carotid artery occlusion; and in-hospital and 30-day transient ischemic attack (TIA), acute myocardial infarction (AMI), and death rates.

Results

Symptoms were present in 131 (17.87%) patients. An embolic protection device was used in 731 (99.72%) patients. Procedural success was 100%, technical success was obtained in all but 1 (99.86%) patient, who died in hospital due to a hemorrhagic stroke. Six TIAs, 2 minor strokes, and 1 AMI occurred during in-hospital stay, and external carotid artery occlusion was evident in 8 (1.09%) patients. Between hospital discharge and 30-day follow-up, 2 TIAs, 1 minor stroke, and 3 AMIs occurred. Therefore, the cumulative stroke rate was 0.54%.

Conclusions

This real-world registry suggests that use of CGuard embolic prevention system in clinical practice is safe and associated with a minimal occurrence of adverse neurological events up to 30-day follow-up.

Key Words

carotid artery disease
carotid artery stenting
stroke

Abbreviations and Acronyms

AMI
acute myocardial infarction
CAS
carotid artery stenting
CEA
carotid endarterectomy
CTA
computed tomographic angiography
DLS
dual-layer mesh-covered carotid stent system(s)
DUS
duplex ultrasound
ECA
external carotid artery
EPD
embolic protection device
EPS
embolic prevention system
ICA
internal carotid artery
TIA
transient ischemic attack

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The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Cardiovascular Interventions author instructions page.