title: Pharmacologic reperfusion therapy with indigenous tenecteplase in 15,222 patients with ST elevation myocardial infarction - the Indian Registry.
abstract: OBJECTIVE
  To study the efficacy and safety of single intravenous bolus administration of indigenously developed tenecteplase (TNK-tPA) in the management of patients with ST-elevation myocardial infarction (STEMI) in clinical practice.
  
  
  METHODS
  Observational, prescription-event monitoring study.
  
  
  RESULTS
  Data of 15,222 patients who had STEMI and received weight adjusted TNK injection was analyzed. Overall 95.43% patients had clinically successful thrombolysis (CST). In the different subgroups, hypertensives, diabetics, smokers and hyperlipidemic patients had CST rates comparable to the general patient data. CST rates were significantly lower in the elderly patients (>70 years; 92.11%; p < 0.0001), in patients with history of Ischemic Heart Disease (IHD, 93.86%; p = 0.0004) and in patients receiving delayed treatment (>6 h after onset of chest pain; 85.38%; p < 0.0001). CST was significantly higher in patients who received an early thrombolysis (<3 h after onset of chest pain; 96.54%; p = 0.006). Overall mortality was 1.69%, while it was significantly higher in the elderly (4.42%), patients with history of IHD (2.67%), females (2.93%) and in those who received delayed treatment (4.98%). The overall incidences of intracranial hemorrhage (ICH), bleeding excluding ICH, stroke and ventricular tachyarrhythmia were 0.39%, 2.01%, 0.16% and 2.35% respectively. Age >70 years, diabetes, hyperlipidemia and history of IHD were associated with a higher incidence of heart failure, myocardial re-infarction or ventricular tachyarrhythmias. However, incidence of ICH and bleeding other than ICH was comparable amongst all patient subgroups.
  
  
  CONCLUSIONS
  This study confirms the safety and efficacy of indigenous tenecteplase in Indian patients with STEMI, including high risk subgroups. It also highlights the fact that delayed treatment denotes denial of benefits of pharmacologic reperfusion therapy.
authors.affiliation: Head, Department of Cardiology, Manipal Heart Institute, Bangalore 56001, India. Electronic address: ssiyengar1945@gmail.com.
authors.forename: S S
authors.initials: SS
authors.lastname: Iyengar
authors.forename: T
authors.initials: T
authors.lastname: Nair
authors.forename: J S
authors.initials: JS
authors.lastname: Hiremath
authors.forename: U
authors.initials: U
authors.lastname: Jadhav
authors.forename: V K
authors.initials: VK
authors.lastname: Katyal
authors.forename: D
authors.initials: D
authors.lastname: Kumbla
authors.forename: I
authors.initials: I
authors.lastname: Sathyamurthy
authors.forename: R K
authors.initials: RK
authors.lastname: Jain
authors.forename: M
authors.initials: M
authors.lastname: Srinivasan
mesh_terms: D000368:Aged; D015897:Comorbidity; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use*; D006801:Humans; D015994:Incidence; D007194:India / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy* / Q000453:epidemiology; D012042:Registries; D000077785:Tenecteplase; D010959:Tissue Plasminogen Activator / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator; D000077785:Tenecteplase
keywords: Prescription-event monitoring; STEMI; Tenecteplase