TERIMA-2: National extension of thrombolytic treatment with recombinant streptokinase in acute myocardial infarct in Cuba

Aim: The extension of recombinant streptokinase (rSK) use in Cuba and to ev aluate its effect on in-hospital mortality of patients with acute myocardia l infarct (AMI). Method's: A phase IV clinical study was performed in 52 ho spitals from the 14 Cuban provinces. Patients (any age) with ST segment ele vation or bundle branch block were included if they came less than 12 h aft er the onset of AMI symptoms, without contraindications for thrombolytic th erapy. They received 1.5 X 10(6) IU of rSK (Heberkinasa, Heberbiotec, Havan a) intravenously, during one hour. Endpoints were death due to cardiac (pum p failure, wall rupture, arrhythmia) or any cause and cardiovascular events at hospital release. Results: The study included 2923 patients, 22 - 98 ye ars-old, 74.4% men, which represented 37.2% of the total AMI patients atten ded 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 (2 2.3% 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 ma de before rSK treatment was introduced. In a logistic regression analysis, mortality was favored by age, symptoms - infusion time, Killip class, and n ot having taken aspirin or betablockers. Feminine gender was close to the l imit of significance. The more frequent adverse events were arrhythmias and hypotension during infusion. Major bleeding occurred in 27 patients (9 str okes). Conclusion: Local recombinant-DNA biotechnology can influence on a m ajor health problem with favorable cost/ and risk/ benefit balances, not po ssible in a developing country with an imported drug. The further extension of this treatment in the country is feasible and recommended, monitored th rough an appropriate pharmacosurveillance program.