Intra-arterial Mechanical Thrombectomy Stent Retrievers and Aspiration Devices in the Treatment of Acute Ischaemic Stroke: A Systematic Review and Meta-Analysis with Trial Sequential Analysis

Flynn, Darren, Francis, Richard, Halvorsrud, Kristoffer, Gonzalo-Almorox, Eduardo, Craig, Dawn, Robalino, Shannon, McMeekin, Peter, Cora, Adela, Balami, Joyce, Ford, Gary and White, Phil (2017) Intra-arterial Mechanical Thrombectomy Stent Retrievers and Aspiration Devices in the Treatment of Acute Ischaemic Stroke: A Systematic Review and Meta-Analysis with Trial Sequential Analysis. European Stroke Journal, 2 (4). pp. 308-318. ISSN 2396-9873

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Abstract

Purpose:
Intra-arterial mechanical thrombectomy (MT) combined with appropriate patient selection (image-based selection of acute ischaemic stroke patients with large artery occlusion) yields improved clinical outcomes. We conducted a systematic review and meta-analysis, with trial sequential analysis (TSA) to understand the benefits, risks and impact of new trials reporting in 2016 on the magnitude/certainty of the estimates for clinical effectiveness and safety of MT.

Method:
Random effects models were conducted of randomised clinical trials comparing MT (stent retriever or aspiration devices) with/without adjuvant intravenous thrombolysis (IVT) with IVT and other forms of best medical/supportive care in the treatment of acute ischaemic stroke. Study inclusion and risk of bias were assessed independently by two reviewers. Functional independence (mRS 0-2) and mortality at 90 days, including symptomatic intracranial haemorrhage (SICH) rate were extracted. TSA established the strength of the evidence derived from the meta-analyses.

Findings:
Eight trials of MT with a total sample size of 1,841 (916 patients treated with MT and 925 treated without MT) fulfilled review inclusion criteria. The three most recent trials more precisely defined the effectiveness of MT (mRS 0 to 2; OR = 2.07, 95% CI = 1.70 to 2.51 based on data from eight trials versus OR = 2.39, 95% CI = 1.88 to 3.04 based on data from five trials). Meta-analyses showed no effect on mortality (OR = 0.81, 95% CI = 0.61 to 1.07) or SICH (OR = 1.22, 95% CI = 0.80 to 1.85) as found in analysis of first five trials. TSA indicated that the information size requirement was fulfilled to conclude the evidence for MT is robust.

Discussion:
The impact of three recent trials on effectiveness and safety of MT was a more precise pooled effect size for functional independence. TSA demonstrated sufficient evidence for effectiveness and safety of MT.

Conclusion:
No further trials of MT versus no MT are indicated to establish clinical effectiveness. Uncertainty remains as to whether MT reduces mortality or increases risk of SICH.

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