Double layered stents for carotid angioplasty: A meta-analysis
of available clinical data
Anna Sannino, MD
Giuseppe Giugliano, MD, PhD
Evelina Toscano, MD
Gabriele G. Schiattarella, MD
Anna Franzone, MD, PhD
Tullio Tesorio, MD
Bruno Trimarco, MD
Giovanni Esposito, MD, PhD
Eugenio Stabile, MD, PhD
Division of Cardiology, University of Naples
“Federico II”, Naples, Italy
Department of Advanced Biomedical
Sciences, University of Naples “Federico II”,
Division of Invasive Cardiology, Clinica
Montevergine, Mercogliano, Italy
Eugenio Stabile, MD, PhD, Division of
Cardiology, Department of Advanced
Biomedical Sciences, University of Naples
“Federico II”, Naples, Italy.
Objectives: The objective of this meta-analysis is to evaluate clinical efficacy of double layered
mesh covered carotid stent systems in the clinical practice.
Background: The need for an increase plaque coverage to decrease the risk of debris dislodge-
ment through the stent struts, following carotid artery stenting (CAS), has brought to the design of
a new generation of double layered carotid stents. Several small sized clinical studies evaluating
two different devices have been recently published, unfortunately these are not sufficiently pow-
ered to test for device related and clinical endpoints and no comparison, between the two
available devices, has been reported yet.
Methods: Ten studies, enrolling 635 patients, were included in the present meta-analysis. Our
study analyzed a composite endpoint of 30-day stroke and death and the occurrence of procedural
unsuccess after CAS with the use of two different double layered carotid stent systems.
Results: Thirty-day stroke and death rate was quite low (patients 635, event rate 0.02, 95% CI:
0.01–0.04, P < 0.0001). The incidence of procedural unsuccess with these devices was relatively
low (patients 635, event rate 0.03, 95% CI: 0.01–0.08, P < 0.0001). When a subgroup analysis was
performed, according to the specific subtype of carotid stent, no differences in the occurrence of
30-day death and stroke rate and procedural unsuccess were observed (P 5 0.979).
Conclusions: This meta-analysis suggests that dual layered carotid stents could be safely used for
the treatment of extracranial carotid artery stenosis, with a relatively low rate of procedural unsuc-
cess, and allow achieving a quite low rate of postprocedural adverse events.
carotid artery disease, intervention, stent design/structure/coatings, stroke
Procedural and post-procedural cerebral ischemic events still represent
the Achilles heel of carotid artery stenting (CAS) [1,2]. While the occur-
rence of periprocedural events has almost been annulled by the use of
embolic protection device (EPD), tailored to specific anatomic and
clinical characteristics , large-scale clinical data showed that, after
the first 30 days, postprocedural ipsilateral stroke still account for a sig-
nificant proportion of all CAS-related adverse events (i.e., 0.4% per
year) [1,2] and this phenomenon could be related to plaque protrusion
through stent struts, which occurs in more than half of the cases .
Recently, the risk of post-procedural adverse cerebral event has
been linked to the size of the carotid stent free cell area indicating a
robust impact of the carotid stent design on CAS outcome . The
*Anna Sannino and Giuseppe Giugliano contributed equally to this work.
Catheter Cardiovasc Interv. 2018;91:751–757. wileyonlinelibrary.com/journal/ccd
2017 Wiley Periodicals, Inc.
Received: 15 December 2016
Revised: 26 September 2017
Accepted: 30 October 2017