Effectiveness and safety of dual-layer stents in carotid artery disease: a systematic review.

INTRODUCTION

Carotid artery stenting (CAS) has emerged as a minimally invasive alternative to carotid endarterectomy (CEA) in atherosclerotic carotid artery disease, even though the risk for procedural stroke after CAS remains significantly higher. Recently, in order to reduce embolic cerebral events after CAS, a new generation of dual-layer stents (DLS) has been developed. This review aimed to perform a detailed analysis of the available evidence on safety and efficacy of DLS in both symptomatic and asymptomatic atherosclerotic carotid artery stenosis.

EVIDENCE ACQUISITION: A systematic review was conducted according to the recommendations of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. The primary endpoint was the 30-day rate of myocardial infarction (MI), stroke and death. Secondary outcomes included rate and timing of stent occlusion/restenosis.

EVIDENCE SYNTHESIS: A total of 20 articles with 1193 patients were included. Thirty-day MI ranged from 0-5%, 30-day stroke ranged from 0-10.5% and 30-day mortality ranged from 0-10%. Stent occlusion rate ranged from 0-52.4%, the majority of which occurred intraprocedurally (N.=50; 61.7%), in emergency treated patients. The incidence of new ipsilateral cerebral ischemic lesions after CAS with DLS was reported in five studies, ranging from 5.5-37%.

CONCLUSIONS

Despite the theoretic advantage of reducing the risk for procedural embolic events when compared to conventional stents, high quality evidence is scarce. Also, safety issues regarding DLS in the emergency setting have been raised, particularly for thrombotic complications. Additional data from well-designed Randomized Controlled Trials are needed to assert the true value of DLS.