title: Angiographic patency study of an albumin-free recombinant streptokinase formulation in acute myocardial infarction.
abstract: OBJECTIVE
  Fibrinolytic therapy restores coronary patency and reduces mortality in patients with acute myocardial infarction. Albumin is present in most of the streptokinase formulation as a stabilizer but it is not known whether it plays a role in the product's efficacy and safety profiles. The aim of this study was to assess 90 minutes-coronary patency of a new albumin-free recombinant streptokinase (rSK) formulation. METHODS . Patients with ischemic chest pain and ST-segment elevation, less than 12 hours after symptoms onset, without contraindications for fibrinolytic therapy, were included to receive 1.5 x 10(6) IU of rSK in a one-hour intravenous infusion. Angiography was performed 90 minutes after and coronary patency was classified according to the TIMI flow scales.
  
  
  RESULTS
  The study enrolled 25 patients, 59.4 +/- 9.2 years-old, 88% men and 92% white. The mean time interval between the symptoms onset and rSK infusion was 3.0 +/- 2.0 hours. Patency rate (TIMI 2-3) of the infarct-related vessel was 72% (18/25). Partial or complete ST-segment resolution was achieved in 17 patients (68%). Hypotension and nauseas were the most frequent adverse events. Haemorrhage or in-hospital deaths were not reported.
  
  
  CONCLUSIONS
  This study suggests that intravenous albumin-free rSK is a safe and appropriate therapy to get early (90-minute) coronary patency in patients with acute myocardial infarction.
authors.affiliation: Institute for Cardiology and Cardiovascular Surgery, Havana.
authors.forename: Lorenzo D
authors.initials: LD
authors.lastname: Llerena
authors.forename: Juan J
authors.initials: JJ
authors.lastname: Quirós
authors.forename: Benito
authors.initials: B
authors.lastname: Sainz
authors.forename: José A
authors.initials: JA
authors.lastname: Valdés
authors.forename: Biolkys
authors.initials: B
authors.lastname: Zorio
authors.forename: Luis H
authors.initials: LH
authors.lastname: Villanueva
authors.forename: César E
authors.initials: CE
authors.lastname: Filgueiras
authors.forename: Francisco
authors.initials: F
authors.lastname: Cabrera
authors.forename: Julio C
authors.initials: JC
authors.lastname: Echarte
authors.forename: Jesús M
authors.initials: JM
authors.lastname: Pérez del Todo
authors.forename: Israel
authors.initials: I
authors.lastname: Guerrero
authors.forename: Leonardo
authors.initials: L
authors.lastname: López
authors.forename: Ernesto J
authors.initials: EJ
authors.lastname: García
authors.forename: Betty
authors.initials: B
authors.lastname: Nadal
authors.forename: Blas Y
authors.initials: BY
authors.lastname: Betancourt
authors.forename: Gisou
authors.initials: G
authors.lastname: Díaz-Rojo
authors.forename: Ana I
authors.initials: AI
authors.lastname: García
authors.forename: Pedro
authors.initials: P
authors.lastname: López-Saura
mesh_terms: D000208:Acute Disease; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy*; D010865:Pilot Projects; D013300:Streptokinase / Q000009:adverse effects / Q000627:therapeutic use*; D015912:Thrombolytic Therapy; D016896:Treatment Outcome; D014654:Vascular Patency / Q000187:drug effects
chemical_list: D013300:Streptokinase