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.