Real-World Data of Tenecteplase Versus Alteplase in the Treatment of Acute Ischemic Stroke: A Single-Center Analysis

medrxiv(2024)

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BACKGROUND AND PURPOSE Tenecteplase was demonstrated pharmacological superiority over alteplase, potentially translating into clinical benefits. Numerous studies have confirmed that the effectiveness and safety of tenecteplase in acute ischemic stroke (AIS) treatment may not be inferior to that of alteplase, and it has potential workflow advantages. This study aimed to evaluate whether tenecteplase’s use in routine clinical practice has time management advantages and corresponding clinical benefits. METHODS The study included AIS patients treated with alteplase at the first affiliated Hospital of Ningbo University from January 2022 to February 2023, and those treated with tenecteplase from March 2023 to November 2023. We compared baseline clinical characteristics, key reperfusion therapy time indices (onset-to-treatment time [OTT], door-to-needle time [DNT], and door-to-puncture time [DPT]), and clinical outcomes (24-hour post-thrombolysis National Institutes of Health Stroke Scale [NIHSS] improvement, and intracranial hemorrhage incidence) between the groups using univariate analysis. We also assessed hospital stay durations and used binary logistic regression to examine tenecteplase’s association with DNT and DPT target times, NIHSS improvement, and intracranial hemorrhage. RESULTS 120 patients treated with tenecteplase and 144 with alteplase were included in the study. Baseline characteristics showed no significant differences in demographic data (sex and age), vascular risk factors (body mass index, hypertension, diabetes), baseline NIHSS, mRS, and bridging thrombectomy (P > 0.05). However, the tenecteplase group had a higher prevalence of hyperlipidemia (21.7% vs. 12.5%, P=0.047) and a lower incidence of atrial fibrillation (21.7% vs. 34%, P=0.027). Key time indices for AIS reperfusion therapy, such as OTT (133 vs. 163.72, P=0.001), DNT (36.5 vs. 50, P < 0.001), and DPT (117 vs. 193, P=0.002), were significantly faster in the tenecteplase group. Additionally, the rates of DNT ≤ 45 min (65.83% vs. 40.44%, P < 0.001) and DPT ≤ 120 min (59.09% vs. 13.79%, P=0.001) were significantly higher in the tenecteplase group compared to the alteplase group. Tenecteplase was an independent predictor of achieving target times for DNT (OR 2.951, 95% CI 1.732-5.030; P < 0.001) and DPT (OR 7.867, 95% CI 1.290-47.991; P=0.025). Clinically, the proportion of patients with NIHSS improvement 24 hours post-thrombolysis was significantly higher in the tenecteplase group (64.17% vs. 50%, P=0.024). No significant differences were observed in the incidences of symptomatic intracranial hemorrhage (sICH) or any intracranial hemorrhage (ICH) (P > 0.05). Patients receiving tenecteplase had shorter hospital stays (6 vs. 8 days, P < 0.001). In binary logistic regression models, tenecteplase was an independent predictor of NIHSS improvement at 24 hours (OR 1.715, 95% CI 1.011-2.908; P=0.045). There was no significant association between thrombolytic choice and sICH or any ICH (P > 0.05). CONCLUSIONS Venous thrombolysis with tenecteplase in AIS treatment significantly reduced DNT and DPT. It was associated with early neurological function improvement (at 24 hours), without compromising safety compared to alteplase. Shorter length of hospital stays for patients were found in the tenecteplase group. The findings support tenecteplase’s application in AIS as a new treatment choice. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement None. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The medical ethics committee of the First Affiliated Hospital of Ningbo University Address?No. 59 Liuting Street, Haishu District, Ningbo, Zhejiang,315000, China Telephone:86-0574-87085233 I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes The data are not publicly available due to their containing information that could compromise the privacy of research participants.
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