Abstract TP12: Comparison of 3D Stent Retriever to Solitaire in Patients with Small Ischemic Cores: An Analysis of the Penumbra 3D Trial
Introduction: A recent meta-analysis of four randomized controlled trials (RCTs) concluded that mechanical thrombectomy using Solitaire for large vessel ischemic stroke was effective with significantly reduced disability.
Hypothesis: Our hypothesis was that treatment with the Penumbra Aspiration System and the novel 3D Stent Retriever would demonstrate similar angiographic and functional outcomes compared to use of Solitaire.
Methods: The 3D trial was a RCT to compare the safety and effectiveness of the 3D Stent Retriever when used with the Penumbra Aspiration System (3D/PS) compared to the PS alone. Inclusion criteria for the 3D RCT included presentation with NIH Stroke Scale ≥ 8 and refractory to or not eligible for IV rtPA. Analysis compared reperfusion to mTICI 2b or 3 and functional independence (mRS 0-2 at 90 days) in a 3D Trial cohort with ASPECTS 8-10 vs the meta-analysis data reported by Campbell et al (Stroke 2016).
Results: One hundred four (104) of 198 patients met analysis criteria. Baseline ASPECTS (median [IQR]) were similar between the 3D Trial ASPECTS 8-10 cohort (3D/PS, PS, combined: 9 [8,10]) and Campbell group (9 [7,10]). Substantial reperfusion (mTICI 2b or 3) was experienced in 84.6% (44/52) of 3D/PS and 75.0% (39/52) of PS alone cases, similar to the Campbell group (76.6%). When both arms were pooled, results (79.8%) were also similar to Campbell. With regards to functional independence, both 3D cohorts and pooled trial results showed similar rates compared with Campbell (Figure).
Conclusions: The novel 3D Stent Retriever + Penumbra System and the Penumbra Aspiration System alone showed similar reperfusion and functional outcomes compared to Solitaire.
Author Disclosures: 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. D. Frei: Ownership Interest; Modest; Penumbra, Inc.. Consultant/Advisory Board; Modest; Penumbra, Inc., Codman, Microvention, Stryker, Siemens. A.J. Yoo: Other Research Support; Modest; Neuravi, Inc.. Other Research Support; Significant; Penumbra, Inc. G. Soulimani: Employment; Significant; Penumbra, Inc. H. Buell: Employment; Significant; Penumbra, Inc. S.S. Kuo: 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.. R. Nogueira: None.
- © 2017 by American Heart Association, Inc.