Abstract Background and aims In prior randomized trials of bridging therapy with intravenous (IV) thrombolytics, stent retrievers were the primary thrombectomy device. The impact of IV thrombolysis on the outcomes of aspiration thrombectomy is unknown. Methods The Imperative Trial was a prospective, investigational device exemption, multicenter trial of first-line aspiration thrombectomy that assessed the safety and efficacy of the Zoom System (including a novel 0.088″ aspiration catheter in patients with stroke within 8 hours of onset). In this pre-specified analysis, we compared outcomes of aspiration thrombectomy based on whether patients had received IV thrombolytics prior to the intervention. Results Among the 260 patients treated with front-line aspiration thrombectomy, 125 (48%) received IV thrombolysis prior to aspiration (68 - Alteplase and 57 -Tenecteplase). Distal clot migration was observed in 17% (19/115 patients) and 6.8% (9/133 patients) of cases in the IV combined and aspiration only groups (P=0.025). Rates of mTICI≥ 2b were higher in the aspiration-alone group than the combined group (92% vs 81%, P=0.016). The use of rescue devices to achieve mTICI ≥2b was less frequent in the aspiration-only group than the combined group (2% vs 10%, P=0.008). The rate of functional independence (mRS 0-2) in the aspiration-only group and the combined group were 50% and 59% (P=0.16). Univariate (P=0.30) and multivariate (P=0.47) ordinal regression analyses showed no significant correlation of mRS 0-2 with IV thrombolysis. Conclusions Aspiration thrombectomy alone resulted in higher rates of successful reperfusion and reduced the need for rescue devices compared to the combined approach. Clinical outcomes were similar between the two groups. Conflict of interest Maxim Mokin: Grant: NIH; Consultant: Balt USA, Imperative Care, Medtronic, Rapid Pulse; Stock: Bendit Technology, Borvo Medical, Brain Q, Endostream, QAS.AI, Quantanosis.AI, Radical Catheter Technologies, Serenity Medical, Sim Stock: Borvo, Cerebrotech, Egret, Endostream, Q’Apel, Radical Catheters, Rebound Therapeutics, Spartan Micro, Stream Biomedical, Vastrax, Viseon. Shahram Majidi: Consultant: DePuy Synthes, Imperative Care, Medical Device Business Services, Rapid Medical. Dana Tomalty: Consultant: Imperative Care, Inari Medical. Jonathan Grossberg: Grant: Emory Medical Care Foundation, Emory Neurosurgery Catalyst, Georgia Research Alliance, NIH, Uniformed Services University-Surgical Critical Care Initiative; Consultant: Cognition, Imperative Care, NTI, Route 92. Jan Vargas: Consultant: Viz.AI, Imperative Care, Precision Neuro, Q’Apel, Medtronic, Microvention; Stock: Viz.AI, Imperative Care, Borvo, Radical, Synchron. Brett L. Cucchiara: None. Kenneth V. Snyder: Consultant: Boston Scientific, Canon Medical Systems, MicroVention, Medtronic, Stryker, Canon Medical Systems USA Inc; Stock or stock options: Boston Scientific, Access Closure, Niagara Gorge Medical. Hakeem J. Shakir: Consultant: Imperative Care, Q’Apel Medical, Stryker, Terumo; Stock: Borvo Medical, Cerebrotech, Radical Catheter Technologies, Sim Stock: Endostream, Q’Apel, Spartan Micro, Synchron, Von Vascular, Vastrax. Nima Aghaebrahim: Consultant: Penumbra. Dan Hoit: Consultant: Imperative Care, Stryker, Medtronic, MicroVention. Benjamin Yim: Consulting: Penumbra, Stryker, Terumo, Q'apel, Imperative Care, Rapid Medical. Alhamza R. Al-Bayati: Consultant: Medical Device Business Services, Stryker. James M. Milburn1: Consultant: Imperative Care, MicroVention. Neil Haranhalli: None. Michael Nahhas: None. Robert M. Starke: Consultant: Medtronic, Penumbra. Diogo C. Haussen: Consultant: Chiesi USA, DePuy Synthes, Stryker. Justin R. Mascitelli: Consultant: Stryker, Imperative Care.
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Mokin et al. (Fri,) studied this question.
www.synapsesocial.com/papers/69fd7e5cbfa21ec5bbf0689e — DOI: https://doi.org/10.1093/esj/aakag023.424
Maxim Mokin
William Mack
S Majidi
European Stroke Journal
University of Pennsylvania
Emory University
Icahn School of Medicine at Mount Sinai
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