Safety of Adjunctive Intraarterial Tenecteplase Following Mechanical Thrombectomy: The ALLY Pilot Trial

Abstract

Background: Recent studies suggest that the use of adjunctive intraarterial alteplase after mechanical thrombectomy (MT) may improve outcomes; however, there are limited data on the use of intraarterial tenecteplase, a newer-generation lytic, in this acute ischemic stroke patient population. Here, we evaluate the use of intraarterial tenecteplase in the ALLY pilot study (Adjunctive Intraarterial Tenecteplase Following Mechanical Thrombectomy).

Methods: ALLY was a prospective, single-center, nonrandomized pilot study assessing the feasibility and safety of intraarterial tenecteplase up to 4.5 mg in acute ischemic stroke-large vessel occlusion MT patients with incomplete recanalization. The primary safety end point was any intracranial hemorrhage and neurological worsening by ≥4 points on the National Institutes of Health Stroke Scale within 24 hours of treatment with intraarterial tenecteplase. A post hoc analysis was performed with a control cohort of MT patients (ALLY MT) not receiving intraarterial tenecteplase.

Results: From April 2022 to July 2023, 218 MTs were performed at ProMedica Hospital (Toledo, OH), of which 20 patients were enrolled in ALLY. The mean age was 66.1±13.8 years, with 35% women. Median baseline National Institutes of Health Stroke Scale scores and Alberta Stroke Program Early CT Scores were 13 (interquartile range, 9-18.8) and 10 (interquartile range, 9-10), respectively. IV thrombolysis was administered in 55%. Most patients presented with middle cerebral artery occlusion (90%). Post-MT modified Treatment in Cerebral Ischemia grade was 2b and 2c in 11 and 9 patients, respectively. Final modified Treatment in Cerebral Ischemia 2b, 2c, and 3 was achieved in 55% (11/20), 35% (7/20), and 10% (2/20), respectively. Any intracranial hemorrhage was observed in 11 patients; however, only 1 patient had symptomatic intracranial hemorrhage. A favorable functional outcome (modified Rankin Scale score, 0-2) at 90 days was achieved in 50%. No difference in intracranial hemorrhage rates was observed between the ALLY and ALLY MT cohorts.

Conclusions: The use of adjunctive intraarterial tenecteplase up to 4.5 mg in patients with acute ischemic stroke with incomplete reperfusion post-MT is feasible and was not associated with increased rates of hemorrhage. Larger, randomized studies are needed to assess the safety and efficacy of intraarterial tenecteplase in this population.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05172934.

Keywords: hemorrhage; humans; pilot projects; tenecteplase; thrombectomy.