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Abstract
Introduction/Purpose Literature indicates that recanalisation with IV rtPA therapy is more likely when clot length is <8mm. Thin-sliced non-enhanced CT (NCCT) images (2.5 mm or less) may be used to evaluate clot lengths in large artery occlusions. The aim of the THERAPY Trial is to assess safety and effectiveness of the Penumbra System® as adjuvant treatment to IV rtPA in stroke patients with large vessel occlusions and extensive clot burdens in the anterior circulation.
Materials and Methods THERAPY is a prospective, randomised, multicentre, concurrent controlled study. Patients from 18 to 85 yo [n=692] presenting with acute ischaemic stroke symptoms, an NIHSS score of ≥8 and IV rtPA-eligible with evidence of a clot length 8mm or longer in the anterior circulation from reconstructed thin-sliced NCCT are randomised 1 to 1 to IV rtPA therapy alone or combined IV rtPA therapy and adjunctive treatment with the Penumbra System. The primary endpoints are 90-day good functional outcome and incidence of serious adverse events. Secondary endpoints include good functional and neurological outcomes at discharge and 30 days, and the incidence of ICH. An independent Core Lab will review imaging data, while a CEC/DSMB will adjudicate safety.
A preliminary analysis of the reasons for screened failures in IV rtPA-eligible patients indicates the following top criteria for exclusion (see pie chart): NIHSS score <8 and age <18 or >85. Reasons for being unable to obtain consent include shipped from outside institution and/or outside time window to consent (45%), refused consent (9%), no family member present to consent (6%), and no reason provided by the site (40%). In patients who had clot length assessed, roughly 75% meet the criterion of ≥8mm clot length.
Results Approximately 47 centres have committed to THERAPY, of which 41 have received IRB approval. To date, 29 centres have been initiated, and 33 patients are randomised.
Conclusion In keeping with the findings from the IMS III Trial, the randomised, prospective, controlled THERAPY trial may serve as the seminal study to clearly define the role of mechanical thrombectomy in an acute ischaemic stroke cohort who are unlikely to respond to IV rtPA and may benefit from an IV-IA bridging approach.
Disclosures J. Mocco: 1; C; Penumbra, Inc. 3; C; Penumbra, Inc. P. Khatri: 1; C; Penumbra, Inc. O. Zaidat: 1; C; Penumbra, Inc. 3; C; Penumbra, Inc.