Angiographic patency study of an albumin-free recombinant streptokinase formulation in acute myocardial infarction.
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.
Llerena
Lorenzo D
LD
Institute for Cardiology and Cardiovascular Surgery, Havana.
Quirós
Juan J
JJ
Sainz
Benito
B
Valdés
José A
JA
Zorio
Biolkys
B
Villanueva
Luis H
LH
Filgueiras
César E
CE
Cabrera
Francisco
F
Echarte
Julio C
JC
Pérez del Todo
Jesús M
JM
Guerrero
Israel
I
López
Leonardo
L
García
Ernesto J
EJ
Nadal
Betty
B
Betancourt
Blas Y
BY
Díaz-Rojo
Gisou
G
García
Ana I
AI
López-Saura
Pedro
P
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
D013300:Streptokinase