Abstract WMP6: Treatment Effect of 3D Stent Retriever with Aspiration and Aspiration Alone in Acute Ischemic Stroke
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.
Author Disclosures: R. Nogueira: None. D. Frei: Ownership Interest; Modest; Penumbra, Inc.. Consultant/Advisory Board; Modest; Penumbra, Inc., Codman, Microvention, Stryker, Siemens. G. Soulimani: Employment; Significant; Penumbra, Inc. S.S. Kuo: Employment; Significant; Penumbra, Inc. H. Buell: Employment; Significant; Penumbra, Inc. E. Mualem: Employment; Significant; Penumbra, Inc. L. Barraza: Employment; Significant; Penumbra, Inc. A. Bose: Employment; Significant; Penumbra, Inc.. Ownership Interest; Significant; Penumbra, Inc. S. Sit: Employment; Significant; Penumbra, Inc.. Ownership Interest; Significant; Penumbra, Inc. A. Siddiqui: Ownership Interest; Modest; StimSox, Medina Medical Systems, Valor Medical. Consultant/Advisory Board; Modest; Codman, GuidePoint Global Consulting, Penumbra (Consultant and PI/National Steeering Committee for 3D Separator Trial, INVEST Trial, COMPASS Trial), Stryker, MicroVention (Consultant and PI/National Steering Committee for FRED Trial, CONFIDENCE Study, LARGE Trial, POSITIVE Trials), Three Rivers Medical, Inc, Corindus, Inc, Amnis Therapeutics, Ltd, CereVasc, LLC, Cerebrotech Medical Systems, Inc, Rapid Medical, Neuravi, Silk Road Medical, Rebound Medical, Intersocietal Accreditation Committee. Research Grant; Significant; : NINDS 1R01NS064592-01A1, NIBIB 5 R01 EB002873-07, NIH/NINDS 1R01NS091075, NIH-NICHHD R01 HD-04483101. Ownership Interest; Significant; Neuro Technology Investors, Cardinal Health, Buffalo Technology Partners, Inc, International Medical Distribution Partners. Consultant/Advisory Board; Significant; Medtronic (Consultant and PI/National Steering Committee for SWIFT PRIME & SWIFT DIRECT Trials), W.L. Gore & Associates, Pulsar Vascular, The Stroke Project, Inc..
- © 2017 by American Heart Association, Inc.