The safety and efficacy of pRESET stent retriever for treatment of thrombo-embolic stroke; a systematic review and meta-analysis

Abstract

Background The pRESET stent retriever is a self-expanding nitinol stent designed for mechanical thrombectomy in cases of large vessel occlusion during acute ischemic stroke. This systematic review and meta-analysis synthesize the available evidence on the safety and efficacy of the pRESET device. Methods This is a systematic review and meta-analysis study conducted based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). The electronic databases of PubMed, Embase, WoS, and Scopus were systematically reviewed from inception to 8 July 2024. Results A total of eight studies involving 1163 patients were included. The pooled mortality rate was 18% with a 95% CI of [12%, 25%]. The rates of any hemorrhagic complication, parenchymal hemorrhage, and subarachnoid hemorrhage were 22% with a 95% CI of [12%, 36%], 7% with a 95% CI of [4%, 13%], and 10% with a 95% CI of [5%, 17%], respectively. The rate of favorable functional outcome (modified Rankin Scale 0-2) at 90 days was 43% with a 95% CI of [34%, 52%]. Successful recanalization rates were 60% with a 95% CI of [52%, 67%] after the first pass and 90% with a 95% CI of [83%, 95%] after the final pass. Rescue devices were used in 13% with a 95% CI of [7%, 24%] of cases. Conclusions The pRESET stent retriever demonstrates high recanalization rates and reasonable safety outcomes in patients undergoing mechanical thrombectomy for acute ischemic stroke due to large vessel occlusion. Further randomized trials directly comparing pRESET to other stent retrievers are warranted.