Alexander Sekita, Gabriela Siedler, Jochen A Sembill, Manuel Schmidt, Ludwig Singer, Bernd Kallmuenzer, Lena Mers, Anna Bogdanova, Stefan Schwab, Stefan T Gerner
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At our tertiary care center, we transitioned from rt-PA to TNK, providing valuable real-world insights into this process, including its use beyond the 4.5-hour time window.</p><p><strong>Methods: </strong>We retrospectively analyzed our stroke registry to compare clinical and procedural data from AIS patients treated with rt-PA (up to 6 months before transition) and those treated with TNK (up to 6 months after transition, starting June 2024). Primary endpoints included treatment metrics, such as door-to-needle (DTN), door-to-imaging (DTI), imaging-to-needle (ITN), door-to-groin and door-to-recanalization times. Safety outcomes comprised rate of any intracranial hemorrhage (ICH), symptomatic ICH (sICH), parenchymatous hematoma type 2 (PH 2) and post-thrombolysis angioedema. A semiquantitative questionnaire evaluated satisfaction with TNK and changes in lysis behavior among nurses and physicians 3 months post-implementation.</p><p><strong>Results: </strong>During the twelve-month period (December 1, 2023 - November 30, 2024), 276 patients underwent IVT. Median DTN times were significantly shorter with TNK (n = 138) compared to rt-PA (n = 138) (TNK 27 min [IQR 19-39] vs. rt-PA 34 min [IQR 25-62]; p = 0.011). No significant differences were observed in safety outcomes, including any ICH (TNK 9% vs. rt-PA 6%; p = 0.30), sICH (2% vs. 1%; p = 0.31), PH 2 rates (1% in both groups), or angioedema (3% vs. 1%; p = 0.18). Staff satisfaction with TNK was high, citing advantages in preparation, administration, and time efficiency. Importantly, no changes in lysis behavior were reported following the transition.</p><p><strong>Conclusions: </strong>Transitioning to TNK in routine practice at a tertiary care center seems feasible with reduced ITN and consequently DTN times. Functional outcomes at discharge were comparable without significant difference in the rate of (s)ICH. 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At our tertiary care center, we transitioned from rt-PA to TNK, providing valuable real-world insights into this process, including its use beyond the 4.5-hour time window.</p><p><strong>Methods: </strong>We retrospectively analyzed our stroke registry to compare clinical and procedural data from AIS patients treated with rt-PA (up to 6 months before transition) and those treated with TNK (up to 6 months after transition, starting June 2024). Primary endpoints included treatment metrics, such as door-to-needle (DTN), door-to-imaging (DTI), imaging-to-needle (ITN), door-to-groin and door-to-recanalization times. Safety outcomes comprised rate of any intracranial hemorrhage (ICH), symptomatic ICH (sICH), parenchymatous hematoma type 2 (PH 2) and post-thrombolysis angioedema. 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引用次数: 0
摘要
背景:Tenecteplase (TNK)为急性缺血性卒中(AIS)静脉溶栓(IVT)提供了有希望的疗效和安全性数据,以及与阿替普酶(rt-PA)相比的药理学优势,证明其逐渐被采用为主要的溶栓药物。在我们的三级护理中心,我们从rt-PA过渡到TNK,提供了对这一过程的有价值的真实见解,包括其在4.5小时时间窗口之外的使用情况。方法:我们回顾性分析卒中注册表,比较接受rt-PA治疗(过渡前6个月)和接受TNK治疗(过渡后6个月,从2024年6月开始)的AIS患者的临床和手术数据。主要终点包括治疗指标,如门到针(DTN)、门到成像(DTI)、成像到针(ITN)、门到腹股沟和门到再通时间。安全性指标包括颅内出血(ICH)、症状性ICH (sICH)、2型实质血肿(ph2)和溶栓后血管性水肿的发生率。一份半定量问卷评估了实施TNK 3个月后护士和医生对TNK的满意度和松解行为的变化。结果:在2023年12月1日至2024年11月30日的12个月期间,276例患者接受了IVT治疗。TNK组中位DTN时间(n = 138)明显短于rt-PA组(n = 138) (TNK 27 min [IQR 19-39] vs. rt-PA 34 min [IQR 25-62];p = 0.011)。安全性结果未观察到显著差异,包括任何ICH (TNK 9% vs. rt-PA 6%;p = 0.30), sICH (2% vs. 1%;p = 0.31), PH 2率(两组均为1%),或血管性水肿(3% vs. 1%;p = 0.18)。员工对TNK的满意度很高,他们认为TNK在准备、管理和时间效率方面具有优势。重要的是,在转化后没有报道裂解行为的变化。结论:在三级保健中心的常规实践中过渡到TNK似乎是可行的,减少了ITN,从而减少了DTN时间。出院时的功能结果具有可比性,脑出血发生率无显著差异。总体而言,向TNK的过渡受到医务人员的欢迎,突出了TNK在急性卒中治疗中的实际优势。试验注册:无注册
Switch to tenecteplase for intravenous thrombolysis in stroke patients: experience from a German high-volume stroke center.
Background: Tenecteplase (TNK) offers promising efficacy and safety data for intravenous thrombolysis (IVT) in acute ischemic stroke (AIS) and pharmacological advantages over alteplase (rt-PA), justifying its gradual adoption as primary thrombolytic agent. At our tertiary care center, we transitioned from rt-PA to TNK, providing valuable real-world insights into this process, including its use beyond the 4.5-hour time window.
Methods: We retrospectively analyzed our stroke registry to compare clinical and procedural data from AIS patients treated with rt-PA (up to 6 months before transition) and those treated with TNK (up to 6 months after transition, starting June 2024). Primary endpoints included treatment metrics, such as door-to-needle (DTN), door-to-imaging (DTI), imaging-to-needle (ITN), door-to-groin and door-to-recanalization times. Safety outcomes comprised rate of any intracranial hemorrhage (ICH), symptomatic ICH (sICH), parenchymatous hematoma type 2 (PH 2) and post-thrombolysis angioedema. A semiquantitative questionnaire evaluated satisfaction with TNK and changes in lysis behavior among nurses and physicians 3 months post-implementation.
Results: During the twelve-month period (December 1, 2023 - November 30, 2024), 276 patients underwent IVT. Median DTN times were significantly shorter with TNK (n = 138) compared to rt-PA (n = 138) (TNK 27 min [IQR 19-39] vs. rt-PA 34 min [IQR 25-62]; p = 0.011). No significant differences were observed in safety outcomes, including any ICH (TNK 9% vs. rt-PA 6%; p = 0.30), sICH (2% vs. 1%; p = 0.31), PH 2 rates (1% in both groups), or angioedema (3% vs. 1%; p = 0.18). Staff satisfaction with TNK was high, citing advantages in preparation, administration, and time efficiency. Importantly, no changes in lysis behavior were reported following the transition.
Conclusions: Transitioning to TNK in routine practice at a tertiary care center seems feasible with reduced ITN and consequently DTN times. Functional outcomes at discharge were comparable without significant difference in the rate of (s)ICH. Overall, the transition to TNK was well-received by medical staff, highlighting TNK's practical advantages in acute stroke care.