Indian registry in ischemic stroke- tenecteplase (IRIS- TNK)- An interim analysis

Abstract

Tenecteplase, a promising third generation Tissue Plasminogen Activator due to greater fibrin specificity and long half-life was approved in 2016 by Indian Regulatory Authority. The IRIS-TNK was opened to study its safety and efficacy. The present study is its interim analysis. To study whether regular use of tenecteplase within 3 hours of ischemic stroke onset is Safe and Beneficial. It is a prospective, open label, nonrandomized observational Registry. Patients satisfying the eligibility criteria were thrombolysed with injection TenectaseR (Tenecteplase manufactured by Gennova Pharmaceuticals, India) at 0.2mg/Kg as intravenous bolus within 3 hours of onset and followed for 3 months. Symptomatic intracerebral haemorrhage (sICH) within 30-42hours of thrombolysis (post treatment scan) with worsening National Institute of Heath Stroke Scale (NIHSS) score by 4 or death. A. Improvement in NIHSS score by 4 or more or 0 at 24hours and 7days B. Functional Independence: modified Rankin Scale (mRS) 0-2 at 3months C. Excellent Outcome- mRS 0-1 at 3months We analysed 240 patients from November 2017 to January 2019. There was a lower incidence of sICH(1.68%) and lower 3 month mortality (5%). Improvement in NIHSS score was seen in 39% at 24 hours and 59% at 7 days. At 3 months, excellent outcome was seen in 59%, while 76% had functional independence. These compared favourably with other registries using Alteplase. Intravenous Tenecteplase at 0.2mg/kg given within 3 hours of stroke onset has a good safety profile and is an effective option with ease of administration and affordability for developing countries.