Streptase - Thrombolytic Therapy for Acute Myocardial Infarction [antikvár]

The GISSI-2 Protocol GISSI-2 (Gruppo Italiano per lo Studio della Soprawi-venza nell' Infarto Miocar-dico) was the first large mortality and morbidity study in which two thrombolytic agents, streptokinase (SK) and recombinant tissue plasminogen activator (rt-PA), were directly compared in treatment of acute myocardial Infarction (AMI)1. 1. GISSI-2 Randomized trial of intravenous alteplase versus intravenous streptokinase in acute myocardial infarction Objectives of the study The objectives of GISSI-2 were: • to estimate the overall mortality and morbidity (congestive heart failure and left ventricular damage) of AMI patients given the available treatments in Coronary Care Units • fo demonstrate how far the pharmacological differences between streptokinase and rt-PA can be translated into clinical benefits • to investigate the role of post-thrombolytic heparin in reducing early ischaemic events (reinfarction) Study Design In GISSI-2 12,490 patients with acute myocardial infarction were randomized within 6 hours after onset of symptoms. Complete data were available for 12,381 patients. The "2x2 factorial" study design allowed the randomization of all the patients to receive either streptokinase or rt-PA and the allocation of half of them to receive heparin (table 1). Treatment Groups The patients were randomly allocated to one of the following treatment groups: • Intravenous infusion of 1,500,000 I.U. of streptokinase within 30-60 min. • Intravenous infusion of 1,500,000 I.U. of streptokinase plus subcutaneous (sc) heparin* (12,500 I.U. every 12 hours during the hospital stay) •Heparin administration started 12 hours • Intravenous infusion of 100 mg of rt-PA over 180 min. • Intravenous infusion of 100 mg of rt-PA plus sc heparin Other Recommended Treatments Along with the study medication, 87% of the patients received oral aspirin (300-325 mg daily) and 45% received atenolol (5-10 mg by slow iv injection). Inclusion Criteria • Chest pain for not more than 6 hours • ST-segment elevation • No contraindications to thrombolytic therapy and/or heparin Exclusion Criteria • Surgery, trauma or other invasive procedures within the last two weeks • Recent or current bleeding • Cerebrovascular accident within the previous 6 months • Severe, uncontrollable hypertension (systolic BPS 200 mm Hg, diastolic BP L 110 mm Hg) • Streptokinase treatment within the last 6 months