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TO ASSESS THE EFFICACY AND SAFETY OF TENECTEPLASE IN ACUTE ISCHEMIC STROKE WITHIN TIME WINDOW PERIOD OF THROMBOLYSIS

Amit Verma, Maqbool Wani, Feroze Shaheen

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Abstract

BACKGROUND: Thrombolysis is the cornerstone of Acute Ischemic Stroke management. Alteplase has its own limitations as low recanalization rates, risk of intracranial hemorrhage, and short half-life, hence Tenecteplase is a more promising alternative. Indian data comparing the efficacy and safety outcomes of tenecteplase and alteplase is scarce. OBJECTIVES: To compare the efficacy and safety profile of tenecteplase with alteplase PARTICIPANTS: Patients aged more than 18 years who came within a window period of 4.5 hours from stroke onset and eligible for thrombolysis, after excluding hemorrhage in plain CT head. STUDY DESIGN: Hospital based prospective comparative study Method: Patients were thrombolysed by Tenecteplase 0.25mg/kg body weight(max 20mg) after all exclusion and inclusion criteria, from September 2018 to march 2021 and data obtained was compared with departmental data of patients already thrombolysed by alteplase(0.9mg/kg, max 90mg). RESULTS: 42 and 34 patients were thrombolysed by tenecteplase and alteplase respectively. Early major neurological improvement seen in 28.6% patients in Tenecteplase but in only 11.8% of patients of alteplase group. In Tenecteplase, excellent functional outcome(mRS 0-1) at 3 months was seen in 67.6%, good functional outcome(mRS 0-2) seen in 73% patients. Poor outcome(mRS 4-6) was seen 16.2%. Median mRS at the time of discharge was 4 and after 3 months it was 1. In Alteplase group, excellent functional outcome(mRS 0-1) seen in 48.5%, good functional outcome(mRS 0-2) seen in 72.7% patients. Poor outcome(mRS 4-6) seen in 21.2% of patients. Median mRS at the time of discharge and at 3 months was 3 and 2. Symptomatic intracranial hemorrhage occurred in Alteplase group(3%) only. CONCLUSIONS: Tenecteplase had shown better safety and efficacy as compared to alteplase IMPLICATIONS:Tenecteplase can be used widely especially in low socioeconomic countries considering its ease of administration and cost.

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BACKGROUND: Thrombolysis is the cornerstone of Acute Ischemic Stroke management. Alteplase has its own limitations as low recanalization rates, risk of intracranial hemorrhage, and short half-life, hence Tenecteplase is a more promising alternative. Indian data comparing the efficacy and safety outcomes of tenecteplase and alteplase is scarce. OBJECTIVES: To compare the efficacy and safety profile of tenecteplase with alteplase PARTICIPANTS: Patients aged more than 18 years who came within a window period of 4.5 hours from stroke onset and eligible for thrombolysis, after excluding hemorrhage in plain CT head. STUDY DESIGN: Hospital based prospective comparative study Method: Patients were thrombolysed by Tenecteplase 0.25mg/kg body weight(max 20mg) after all exclusion and inclusion criteria, from September 2018 to march 2021 and data obtained was compared with departmental data of patients already thrombolysed by alteplase(0.9mg/kg, max 90mg). RESULTS: 42 and 34 patients were thrombolysed by tenecteplase and alteplase respectively. Early major neurological improvement seen in 28.6% patients in Tenecteplase but in only 11.8% of patients of alteplase group. In Tenecteplase, excellent functional outcome(mRS 0-1) at 3 months was seen in 67.6%, good functional outcome(mRS 0-2) seen in 73% patients. Poor outcome(mRS 4-6) was seen 16.2%. Median mRS at the time of discharge was 4 and after 3 months it was 1. In Alteplase group, excellent functional outcome(mRS 0-1) seen in 48.5%, good functional outcome(mRS 0-2) seen in 72.7% patients. Poor outcome(mRS 4-6) seen in 21.2% of patients. Median mRS at the time of discharge and at 3 months was 3 and 2. Symptomatic intracranial hemorrhage occurred in Alteplase group(3%) only. CONCLUSIONS: Tenecteplase had shown better safety and efficacy as compared to alteplase IMPLICATIONS:Tenecteplase can be used widely especially in low socioeconomic countries considering its ease of administration and cost.

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Available abstract

BACKGROUND: Thrombolysis is the cornerstone of Acute Ischemic Stroke management. Alteplase has its own limitations as low recanalization rates, risk of intracranial hemorrhage, and short half-life, hence Tenecteplase is a more promising alternative. Indian data comparing the efficacy and safety outcomes of tenecteplase and alteplase is scarce. OBJECTIVES: To compare the efficacy and safety profile of tenecteplase with alteplase PARTICIPANTS: Patients aged more than 18 years who came within a window period of 4.5 hours from stroke onset and eligible for thrombolysis, after excluding hemorrhage in plain CT head. STUDY DESIGN: Hospital based prospective comparative study Method: Patients were thrombolysed by Tenecteplase 0.25mg/kg body weight(max 20mg) after all exclusion and inclusion criteria, from September 2018 to march 2021 and data obtained was compared with departmental data of patients already thrombolysed by alteplase(0.9mg/kg, max 90mg). RESULTS: 42 and 34 patients were thrombolysed by tenecteplase and alteplase respectively. Early major neurological improvement seen in 28.6% patients in Tenecteplase but in only 11.8% of patients of alteplase group. In Tenecteplase, excellent functional outcome(mRS 0-1) at 3 months was seen in 67.6%, good functional outcome(mRS 0-2) seen in 73% patients. Poor outcome(mRS 4-6) was seen 16.2%. Median mRS at the time of discharge was 4 and after 3 months it was 1. In Alteplase group, excellent functional outcome(mRS 0-1) seen in 48.5%, good functional outcome(mRS 0-2) seen in 72.7% patients. Poor outcome(mRS 4-6) seen in 21.2% of patients. Median mRS at the time of discharge and at 3 months was 3 and 2. Symptomatic intracranial hemorrhage occurred in Alteplase group(3%) only. CONCLUSIONS: Tenecteplase had shown better safety and efficacy as compared to alteplase IMPLICATIONS:Tenecteplase can be used widely especially in low socioeconomic countries considering its ease of administration and cost.

Key concepts: Tenecteplase, Thrombolysis, Medicine, Fibrinolytic agent, Tissue plasminogen activator, Inclusion and exclusion criteria, Stroke (engine), Surgery

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TO ASSESS THE EFFICACY AND SAFETY OF TENECTEPLASE IN ACUTE ISCHEMIC STROKE WITHIN TIME WINDOW PERIOD OF THROMBOLYSIS — Research Paper | ScholarLens