Safety of Adjunctive Intraarterial Tenecteplase Following Mechanical Thrombectomy: The ALLY Pilot Trial
Bibliographic record
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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".