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ESTUDIO ISIS 2

Randomización trial de la intervención de estreptoquinasa,


aspirina oral, juntas o ninguno entre 17187 casos esperados
de infarto agudo de miocardio.
Segundo Estudio Internacional de la Supervivencia
del Infarto.
DISEÑO DEL ESTUDIO

 Internacional, multicéntrico, prospectivo, randomizado

(2x2 Diseño factorial), ensayo controllado con

placebo.
METODOLOGÍA
• Tamaño de la muestra: 17,187 (from 1985 - 1987)

• Intervenciones
• Estreptoquinasa 1.5 MU IV x 1 hr (n = 8592) vs. Placebo (n = 8595)
• Aspirina 162 mg orally (n = 8587) vs Placebo (n = 8600)
• Estreptoquinasa 1.5 MI UV x 1 hr + aspirin 162 mg (n = 4292) vs
Placebo (n= 4300)
METODOLOGÍA

• Seguimiento: Hasta 34 semanas.

• Variable principal: Mortalidad vascular en las 5 primeras semanas

de uso.

• Localización: Europa y USA


RESULTADOS
• Streptokinase alone produced a highly significant reduction in 5-week vascular mortality: 791/8592 (9.2%) vs
1029/8595 (12.0%) with placebo (odds reduction: 25%; 2p < 0.00001)
• Aspirin alone resulted in 804/8587 (9.4%) vascular deaths vs 1016/8600 (11.8%) with placebo (odds reduction: 23%
4; 2p <0.00001).
• The combination of streptokinase and aspirin was significantly (2p less than 0.0001) better than either agent alone.
• Streptokinase was associated with an excess of bleeds requiring transfusion (0.5% vs 0.2%) and of confirmed cerebral
haemorrhage (0.1% vs 0.0%), but with fewer other strokes (0.6% vs 0.8%). These "other" strokes may have included
a few undiagnosed cerebral haemorrhages, but still there was no increase in total strokes (0.7% streptokinase vs 0.8%
placebo infusion).
• Aspirin significantly reduced non-fatal reinfarction (1.0% vs 2.0%) and non-fatal stroke (0.3% vs 0.6%), and was not
associated with any significant increase in cerebral haemorrhage or in bleeds requiring transfusion.
• An excess of non-fatal reinfarction was reported when streptokinase was used alone, but this appeared to be entirely
avoided by the addition of aspirin. Those allocated the combination of streptokinase and aspirin had significantly
fewer reinfarctions (1.8% vs 2.9%), strokes (0.6% vs 1.1%), and deaths (8.0% vs 13.2%) than those allocated neither.
• The differences in vascular and in all-cause mortality produced by streptokinase and by aspirin remain highly
significant (2p < 0.001 for each) after the median of 15 months of follow-up
CONCLUSIONES

• La estreptoquinasa sola y la aspirina sola producen una reducción

significativa de la mortalidad vascular en 5 semanas.