Stent Design, Restenosis and Recurrent Stroke After Carotid Artery Stenting in the International Carotid Stenting Study.

Abstract

Background and Purpose- Open-cell carotid artery stents are associated with a higher peri-procedural stroke risk than closed-cell stents. However, the effect of stent design on long-term durability of carotid artery stenting (CAS) is unknown. We compared the medium- to long-term risk of restenosis and ipsilateral stroke between patients treated with open-cell stents versus closed-cell stents in the ICSS (International Carotid Stenting Study). Methods- Patients with symptomatic carotid stenosis were randomized to CAS or endarterectomy and followed with duplex ultrasound for a median of 4.0 years. We analyzed data from patients with completed CAS procedures, known stent design, and available ultrasound follow-up. The primary outcome, moderate or higher restenosis (≥50%) was defined as a peak systolic velocity of >1.3 m/s on ultrasound or occlusion of the treated internal carotid artery and analyzed with interval-censored models. Results- Eight hundred fifty-five patients were allocated to CAS. Seven hundred fourteen patients with completed CAS and known stent design were included in the current analysis. Of these, 352 were treated with open-cell and 362 with closed-cell stents. Moderate or higher restenosis occurred significantly less frequently in patients treated with open-cell (n=113) than closed-cell stents (n=154; 5-year risks were 35.5% versus 46.0%; unadjusted hazard ratio, 0.68; 95% CI, 0.53-0.88). There was no significant difference in the risk of severe restenosis (≥70%) after open-cell stenting (n=27) versus closed-cell stenting (n=43; 5-year risks, 8.6% versus 12.7%; unadjusted hazard ratio, 0.63; 95% CI, 0.37-1.05). The risk of ipsilateral stroke beyond 30 days after treatment was similar with open-cell and closed-cell stents (hazard ratio, 0.78; 95% CI, 0.35-1.75). Conclusions- Moderate or higher restenosis after CAS occurred less frequently in patients treated with open-cell stents than closed-cell stents. However, both stent designs were equally effective at preventing recurrent stroke during follow-up. Clinical Trial Registration- URL: http://www.isrctn.com/. Unique identifier: ISRCTN25337470.

• Authors: Mandy D Müller, John Gregson, Dominick J H McCabe, Paul J Nederkoorn, H Bart van der Worp, Gert J de Borst, Trevor Cleveland, Thomas Wolff, Stefan T Engelter, Philippe A Lyrer, Martin M Brown, Leo H Bonati
• Journal: Stroke (Stroke) Vol. 50 Issue 11 Pg. 3013-3020 (11 2019) ISSN: 1524-4628 [Electronic] United States
• PMID: 31547798 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Topics

• Aged
• Aged, 80 and over
• Carotid Artery, Internal (diagnostic imaging, surgery)
• Carotid Stenosis (diagnostic imaging, surgery)
• Endarterectomy, Carotid (adverse effects, instrumentation, methods)
• Equipment Design (adverse effects, trends)
• Female
• Follow-Up Studies
• Graft Occlusion, Vascular (diagnostic imaging, etiology)
• Humans
• Internationality
• Male
• Middle Aged
• Recurrence
• Stents (adverse effects, trends)
• Stroke (diagnostic imaging, surgery)