Abstract 43: Comparative Effectiveness Of Routine Tenecteplase Thrombolysis In Acute Stroke Compared With Alteplase: An INternational Collaboration (CERTAIN Collaboration): Rates Of Symptomatic Intracranial Hemorrhage

Abstract

Introduction: Despite pharmacological and practical advantages for tenecteplase (TNK) over alteplase (ALT), no differences were observed in percent of symptomatic intracranial hemorrhage (sICH) in randomized trials (fewer than 900 total patients for either treatment). We compared rates of sICH in patients treated with either drug, using a large, multicenter, international registry. Methods: The CERTAIN collaboration is an ongoing registry of deidentified patient-level data of thrombolytic treated ischemic stroke from various hospitals/programs in New Zealand, Australia, and the United States that have used ALT or TNK since July 1, 2018. Standardized data were abstracted and harmonized from local or regional clinical registries. We defined sICH as clinical worsening of at least 4 points on NIHSS, attributed to parenchymal hematoma, subarachnoid or intraventricular hemorrhage. We used logistic regression for binary variables, adjusting sICH differences for age, baseline NIHSS, thrombectomy, and source hospital network and Mann-Whitney test for continuous baseline variables. Results: A total of 7891 patients were included in the initial analysis. The TNK group was older, more likely to be male, had higher NIHSS, and more frequently underwent mechanical thrombectomy (Table. Sample Characteristics). The sICH rate was 3.71% for ALT and 2.13% for TNK: adjusted OR (95%CI) = 0.49 (0.31-0.76) p=0.002. For patients not undergoing thrombectomy after thrombolytic, the sICH rate was 3.00% for ALT and 1.74% for TNK, adjusted OR (95%CI) = 0.48 (0.27-0.87), p=0.016. For thrombectomy treated cases, sICH rate was 6.80% for ALT and 2.80% for TNK, adjusted OR (95%CI) 0.60 (0.31-1.16), p=0.129. Conclusion: In this preliminary analysis from a large, multicenter registry, ischemic stroke treated with tenecteplase was associated with a lower rate of sICH than with alteplase. An updated analysis with patient data from additional sites will be presented at the Conference.