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Dual-layered carotid artery stents safe
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According to a meta-analysis, use of dual-layered mesh-covered carotid artery stent systems was safe at 30 days.
Researchers analyzed 556 patients (mean age, 72 years; 70% men) from four studies who had one of two dual-layered mesh-covered carotid stent systems implanted (Roadsaver, Terumo; CGuard, InspireMD).
“The need for increased plaque coverage to decrease the risk for debris dislodgement through the stent struts has resulted in the development of a new generation of dual-layered mesh-covered carotid stent systems,” Eugenio Stabile, MD, PhD, from the division of cardiology, department of advanced biomedical sciences, University of Naples, Italy, and colleagues wrote. “These devices basically consist of novel thin-strut nitinol stents combined with mesh covering (which can be made of nitinol or of polyethylene terephthalate). This design allows the device to trap and exclude thrombus and/or plaque debris in order to prevent embolic events from the target lesion.”
The primary endpoint was stroke at 30 days. Secondary endpoints included technical and procedural success, periprocedural stroke, in-hospital mortality and 30-day mortality.
Technical success was achieved in all cases. The periprocedural stroke rate was 1.08%, and all periprocedural strokes were minor, according to the researchers.
The incidence rate of stroke at 30 days was 1.25%, with one minor stroke occurring after the periprocedural period, Stabile and colleagues wrote.
The 30-day mortality rate was 0.17%, representing one patient who died of MI, the researchers wrote.
Stabile and colleagues were unable to identify any predictors of stroke at 30 days.
“There are no clinical, anatomic or procedural characteristics that could be identified in relation to increased risk for peri- or post-procedural adverse events, including lack of the effect of symptomatic status on peri- or post-procedural adverse event risk,” Stabile and colleagues wrote.
“Due to their small pore sizes, treatment of unstable plaques in high-risk lesions is a potential target for this stent type, widening the indication for carotid stenting,” Harold Mudra, MD, from Klinikum Neuperlach, Städtisches Klinikum München in Munich, and Jakob Ledwoch, MD, from Technical University of Munich, wrote in a related editorial. “Ultimately, large randomized trials with longer follow-up comparing mesh-covered stents with [carotid endarterectomy] and/or conventional stents are urgently needed. If such trials can confirm the results of the current studies, this novel stent technology will really represent a new milestone in CAS.” – by Erik Swain
Disclosures: The study and editorial authors report no relevant financial disclosures.
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