Summary
Aim: The extension of recombinant streptokinase (rSK) use in Cuba and to evaluate its
effect on in-hospital mortality of patients with acute myocardial infarct (AMI). Methods: A phase IV clinical study was performed in 52 hospitals from the 14 Cuban provinces.
Patients (any age) with ST segment elevation or bundle branch block were included
if they came less than 12 h after the onset of AMI symptoms, without contraindications
for thrombolytic therapy. They received 1.5 × 106 IU of rSK (Heberkinasa, Heberbiotec, Havana) intravenously, during one hour. Endpoints
were death due to cardiac (pump failure, wall rupture, arrhythmia) or any cause and
cardiovascular events at hospital release. Results: The study included 2923 patients, 22 – 98 years-old, 74.4% men, which represented
37.2% of the total AMI patients attended at the participating hospitals from November
1992 to May 1995. Aspirin was given to 92.5% and betablockers to 65.3%. AMI was confirmed
in 93.5% of the patients. The mean symptoms – rSK infusion time interval was 5.25
h (22.3% of the patients treated within the first 3 h). 302 patients died, 80.1% of
them due to cardiac causes, 12 attributed to rSK treatment, and 16 to non-cardiac
causes. This 10.4% mortality represents a 4% absolute and a 28.3% relative reduction
(179 lives saved per year) as compared to a survey made before rSK treatment was introduced.
In a logistic regression analysis, mortality was favored by age, symptoms – infusion
time, Killip class, and not having taken aspirin or betablockers. Feminine gender
was close to the limit of significance. The more frequent adverse events were arrhythmias
and hypotension during infusion. Major bleeding occurred in 27 patients (9 strokes).
Conclusion: Local recombinant-DNA biotechnology can influence on a major health problem with
favorable cost/ and risk/ benefit balances, not possible in a developing country with
an imported drug. The further extension of this treatment in the country is feasible
and recommended, monitored through an appropriate pharmacosurveillance program.
Key words
Streptokinase - thrombolysis - acute myocardial infarction
