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SAFETY AND OUTCOMES OF IV TENECTEPLASE IN ACUTE ISCHEMIC STROKE : POST APPROVAL EXPERIENCE FROM TERTIARY CARE HOSPITAL IN INDIA

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ESOC-2019

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Abstract

IV rtPA is currently the only thrombolytic therapy approved for use in acute ischemic stroke (AIS) within 4.5 hours. However, TNK has been approved in India for use in AIS within 3 hours (0.2mg/kg-Max 20mg). We describe initial experience with IV TNK in AIS following approval in 2016. Methods:AIS patients admitted in PGIMER Emergency from April 2017 to December 2018 and administered IV TNK were included.Patients fulfilled the standard inclusions and exclusions to thrombolysis. Baseline NIHSS, proportion of patients with improvement of >4points at 24 hours, proportion of patients with modified Rankin Scale (mRS) 0-2 at 3 months was calculated. Safety was assessed from symptomatic intracerebral hemorrhage(SICH) rates as per SITS-MOST definition. Secondary efficacy measure was recanalisation rates at 24 hours of treatment. Results 46 patients with AIS were recruited. Mean age was 56.15 years and 36(78.3 %) were males. The Baseline Median NIHSS was13 (IQR 9-19) and 24 hours NIHSS was 12(IQR 4-18). Median Door to CT time, door to needle time and treatment window periods were 12(IQR 9-17.25), 47.5(IQR 38-57.75) and 162.5(IQR 120-198.75) minutes respectively. Median ASPECT score at baseline was 9(IQR 8-10). 26 (56.5%) had major intracranial artery occlusion. 13(28%) patients had 4 point NIHSS improvement at 24 hours. 7(16.7%) patients had mRS 0-2 at 3 months while the rest had mRS 3-5. 13(28.3%) patients died and 2 patient had a SICH (1 had SAH). 11 (23.9%) had complete recanalisation (TICI 2b-3) Conclusion: IV TNK at dose of 0.2mg/kg - 0.25mg/kg within 3 hours of AIS was associated with poor recanalisation rates and poor outcomes in most patients. Results of the Phase III trials should be awaited before approval of TNK as an economical alternative for AIS.

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© Copyright 2019 Morressier GmbH.
All rights reserved.