ABSTRACT
PURPOSE: 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.
Subject(s)
Myocardial Infarction/drug therapy , Streptokinase/therapeutic use , Acute Disease , Female , Humans , Male , Middle Aged , Pilot Projects , Streptokinase/adverse effects , Thrombolytic Therapy , Treatment Outcome , Vascular Patency/drug effectsABSTRACT
PURPOSE: 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 106 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 percent men and 92 percent 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 percent (18/25). Partial or complete ST-segment resolution was achieved in 17 patients (68 percent). 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(AU)
PROPÓSITO: Terapia fibrinolítica restablece la permeabilidad coronaria y reduce la mortalidad en pacientes con infarto agudo de miocardio. Albúmina está presente en la mayoría de la estreptoquinasa como la formulación de un estabilizador, pero no se sabe si juega un papel en la eficacia del producto y los perfiles de seguridad. El objetivo de este estudio fue evaluar 90 minutos permeabilidad coronaria de un nuevo albúmina libre de la estreptoquinasa recombinante (RSK) formulación. MÉTODOS. Los pacientes con dolor torácico y elevación del segmento ST, a menos de 12 horas después de los síntomas de inicio, sin contraindicaciones para la terapia fibrinolítica, se incluyeron para recibir 1,5 x 106 UI de RSK en una hora en perfusión intravenosa. Angiografía se realizó 90 minutos después de permeabilidad coronaria y se clasifican de acuerdo con el flujo TIMI escalas. RESULTADOS. El estudio reclutó 25 pacientes, 59,4 ± 9,2 años, 88 por ciento hombres y 92 por ciento blanco. La media de intervalo de tiempo entre la aparición de los síntomas y RSK perfusión fue de 3,0 ± 2,0 horas. Tasa de permeabilidad (TIMI 2-3) de los buques relacionados con el infarto fue del 72 por ciento (18/25). Parcial o completa del segmento ST resolución se logró en 17 pacientes (68 por ciento). Hipotensión y náuseas fueron los acontecimientos adversos más frecuentes. Hemorragia en el hospital o no se informaron muertes. CONCLUSIONES. Este estudio sugiere que la albúmina intravenosa sin RSK es un tratamiento seguro y apropiado para obtener temprano (90 minutos) permeabilidad coronaria en pacientes con infarto agudo de miocardio
