Efficacy & safety of tenecteplase in 6000 patients with ST-elevation myocardial infarction from the Elaxim Indian Registry.

To study the efficacy and safety of single intravenous bolus administration of indigenously developed tenecteplase in the management of patients presenting with ST-elevation myocardial infarction in clinical practice.Post-licensure, observational, prescription-event monitoring study.Data of 6000 patients who had ST-elevation myocardial infarction and received weight-adjusted tenecteplase injection was analyzed. Overall 90.93% patients had clinically successful thrombolysis, with highest success rate (93.2%) in patients treated within 3 hours. Overall mortality was 3.23%. The elderly (< or = 65 yrs; 24.58%) and diabetics (38.2%) had clinically successful thrombolysis of 87.73% and 90.49% respectively. Female patients (16.38%) had success rates comparable to males but with higher (6.41%) mortality. The overall incidences of intracranial hemorrhage (ICH), severe bleeding, stroke and ventricular tachyarrhythmia were 0.62%, 3.18%, 0.12% and 3.07% respectively and were not significantly different in females, diabetics and elderly patients. Delay in treatment beyond 6 hours was associated with increased incidence of heart failure, ventricular tachyarrhythmia and mortality.This study confirms the efficacy and safety of indigenous tenecteplase in the management of patients with ST-elevation myocardial infarction.