Introduction: A recent meta-analysis of five stroke endovascular therapy (EVT) randomized controlled trials (RCTs) confirmed EVT’s benefits in patients with acute ischemic stroke caused by proximal large vessel occlusion (LVO).
Hypothesis: We hypothesize that treatment with the novel 3D Stent Retriever used with the Penumbra System and the Penumbra System alone could confer similar benefits in this stroke cohort.
Methods: The Penumbra 3D trial was a RCT to compare the safety and efficacy of the 3D Stent Retriever when used in conjunction with the Penumbra Aspiration System (3D/PS) versus the PS alone. Inclusion criteria for the 3D RCT included presentation within 8 hours of symptom onset, NIH Stroke Scale ≥ 8, and refractory to or not eligible for IV rtPA. Analysis compared 90-day mRS 0-2 vs the EVT RCT meta-analysis reported by the HERMES collaboration (Goyal et al., Lancet 2016).
Results: A total of 172 of 198 enrolled patients met analysis criteria. Baseline NIHSS, ASPECTS, and age were similar between the 3D RCT and HERMES control. Successful reperfusion (mTICI 2b-3) occurred in 74.1% of PS alone (63/85) and 83.9% of 3D/PS (73/87) cases. When both arms were pooled, 79.1% (136/172) of cases achieved successful reperfusion. Results on 90-day functional independence showed both 3D cohorts and the pooled results of the trial had significantly higher rates compared to the HERMES control (IV rtPA).
Conclusions: Both the 3D/PS and the PS devices alone showed benefit compared to IV rtPA monotherapy from a recent EVT RCT meta-analysis.