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

medrxiv(2024)

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摘要
BACKGROUND AND PURPOSE: This study aimed to evaluate whether tenecteplase's use in routine clinical practice for acute ischemic stroke (AIS) has time management advantages and clinical benefits. METHODS: 144 AIS patients treated with alteplase and 120 with tenecteplase were included. 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 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: Baseline characteristics showed no significant differences except hyperlipidemia (P=0.047) and atrial fibrillation (P=0.027). 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. 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. Tenecteplase was an independent predictor of achieving target 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 symptomatic intracranial hemorrhage (sICH) or any intracranial hemorrhage (ICH). Patients receiving tenecteplase had shorter hospital stays (6 vs. 8 days, P < 0.001). 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. CONCLUSIONS: Tenecteplase significantly reduced DNT and DPT. It was associated with early neurological function improvement (at 24 hours), without compromising safety compared to alteplase. The findings support tenecteplase's application in AIS. ### 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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