ANGIOX
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    ANGIOX

    Bivalirudina

    Coagulación / trombosis

    Angiox es un inhibidor directo de la trombina que se utiliza como anticoagulante en intervención coronaria percutánea (ICP).1

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    Información adicional

    Indicaciones

    Angiox está indicado como un anticoagulante en pacientes adultos que se someten a intervención coronaria percutánea (ICP), incluidos los pacientes con infarto de miocardio con elevación del segmento ST que se someten a intervención coronaria percutánea primaria.2

    Angiox está asimismo indicado para el tratamiento de pacientes adultos con angina inestable/infarto de miocardio sin elevación del segmento ST (AI/ IAMNST) que van a ser sometidos a una intervención de forma urgente o temprana.

    Angiox debe ser administrado junto con ácido acetilsalicílico y clopidogrel.2

    Posología

    Pacientes que se someten a intervención coronaria percutánea (ICP), incluida ICP primaria.
    La dosis recomendada de bivalirudina en pacientes que se someten a ICP es un bolo intravenoso de 0,75 mg/kg de peso corporal seguido de una perfusión intravenosa a una velocidad de 1,75 mg/kg de peso corporal/h durante al menos, el tiempo que dure el procedimiento. Si está clínicamente justificado se puede alargar la perfusión de 1,75 mg/kg de peso corporal/h hasta un máximo de 4 horas tras la intervención coronaria percutánea, y continuarse a una dosis de perfusión reducida de 0,25 mg/kg/h durante 4 – 12 horas, de ser clínicamente necesario.
    Se debe monitorizar cuidadosamente a los pacientes tras la ICP por si presentan signos y síntomas coherentes con isquemia de miocardio.2

    Pacientes con angina inestable/infarto de miocardio sin elevación del segmento ST.
    La dosis inicial recomendada de bivalirudina en pacientes con síndrome coronario agudo (SCA) es un bolo intravenoso de 0,1 mg/kg seguido de una perfusión de 0,25 mg/kg/h. Los pacientes que tienen que ser tratados médicamente pueden continuar la perfusión de 0,25 mg/kg/h hasta 72 horas.
    Si el paciente se somete a una ICP, debe administrarse un bolo adicional de 0,5 mg/kg de bivalirudina antes de la intervención y la perfusión debe incrementarse a 1,75 mg/kg/h el tiempo que dure la intervención.
    Tras la ICP, la dosis de perfusión reducida de 0,25 mg/kg/h puede reanudarse de 4 a 12 horas después si es clínicamente necesario.
    Para los pacientes que se someten a una cirugía mediante by-pass de la arteria coronaria (CBAC) sin bomba de circulación extracorpórea, debe continuarse con la perfusión intravenosa (IV) de bivalirudina hasta el momento de la cirugía. Justo antes de la cirugía, debe administrarse una dosis en forma de bolo de 0,5 mg/kg seguido de una perfusión intravenosa de 1,75 mg/kg/h durante la cirugía.
    Para los pacientes que se someten a cirugía CBAC con bomba de circulación extracorpórea, debe continuarse la perfusión intravenosa de bivalirudina hasta 1 hora antes de la cirugía después de la cual la perfusión debe interrumpirse y tratar al paciente con heparina no fraccionada (HNF).2

    Forma de administración

    Angiox está destinado a uso intravenoso (IV). Angiox debe reconstituirse de modo que proporcione una solución de 50mg/ml de bivalirudina. El producto reconstituido debe diluirse adicionalmente en un volumen total de 50 ml para proporcionar una solución de 5mg/ml de bivalirudina. Antes de la administración del producto reconstituido y diluido debe mezclarse bien. Angiox se administra en un régimen de dosificación determinado por el peso y la función renal.
    La administración de Angiox consiste en un bolo IV inicial (inyección IV rápida), seguido inmediatamente de una perfusión IV continua.2

    A continuación se muestran las tablas de administración según indicación de uso, peso y función renal:

    ICP e ICP Primaria

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    ICP Urgente o Temprana

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    Seguridad

    Angiox está contraindicado en pacientes con: hipersensibilidad al (a los) principio(s) activo(s) o a alguno de los excipientes del producto incluidos en la sección 6.1, o a las hirudinas; hemorragia activa o riesgo elevado de hemorragia debido a trastornos de la hemostasia y/o trastornos de la coagulación irreversibles; hipertensión incontrolada grave; endocarditis bacteriana subaguda; insuficiencia renal grave (velocidad de filtración glomerular <30 ml/min) y en pacientes dependientes de diálisis.2

    Toda la información sobre seguridad del producto puede ser consultada en la Ficha Técnica.

    Presentaciones

    Angiox 250 mg 10 viales polvo para concentrado para solución inyectable y para perfusión (CN: 650319.5)

     

    Referencias

    Stone GW, Witzenbichler B, Guagliumi G, et al. Bivalirudin during primary PCI in acute myocardial infarction. N Engl J Med. 2008;358:2218-2230.
    2 Agencia Española de Medicamentos y Productos Sanitarios. Centro de Información online de Medicamentos de la AEMPS. Ficha técnica ANGIOX® [sede web]. [Actualizado 2015; acceso noviembre 2015].

    Bivalirudin for patients with acute coronary syndromes

    BACKGROUND: Current guidelines for patients with moderate- or high-risk acute coronary syndromes recommend an early invasive approach with concomitant antithrombotic therapy, including aspirin, clopidogrel, unfractionated or low-molecular-weight heparin, and glycoprotein IIb/IIIa inhibitors. We evaluated the role of thrombin-specific anticoagulation with bivalirudin in such patients.

    METHODS: We assigned 13,819 patients with acute coronary syndromes to one of three antithrombotic regimens: unfractionated heparin or enoxaparin plus a glycoprotein IIb/IIIa inhibitor, bivalirudin plus a glycoprotein IIb/IIIa inhibitor, or bivalirudin alone. The primary end points were a composite ischemia end point (death, myocardial infarction, or unplanned revascularization for ischemia), major bleeding, and the net clinical outcome, defined as the combination of composite ischemia or major bleeding.

    RESULTS: Bivalirudin plus a glycoprotein IIb/IIIa inhibitor, as compared with heparin plus a glycoprotein IIb/IIIa inhibitor, was associated with noninferior 30-day rates of the composite ischemia end point (7.7% and 7.3%, respectively), major bleeding (5.3% and 5.7%), and the net clinical outcome end point (11.8% and 11.7%). Bivalirudin alone, as compared with heparin plus a glycoprotein IIb/IIIa inhibitor, was associated with a noninferior rate of the composite ischemia end point (7.8% and 7.3%, respectively; P=0.32; relative risk, 1.08; 95% confidence interval [CI], 0.93 to 1.24) and significantly reduced rates of major bleeding (3.0% vs. 5.7%; P<0.001; relative risk, 0.53; 95% CI, 0.43 to 0.65) and the net clinical outcome end point (10.1% vs. 11.7%; P=0.02; relative risk, 0.86; 95% CI, 0.77 to 0.97).

    CONCLUSIONS: In patients with moderate- or high-risk acute coronary syndromes who were undergoing invasive treatment with glycoprotein IIb/IIIa inhibitors, bivalirudin was associated with rates of ischemia and bleeding that were similar to those with heparin. Bivalirudin alone was associated with similar rates of ischemia and significantly lower rates of bleeding. 

    Stone GW, McLaurin BT, Cox DA et al; for the ACUITY Investigators.
    N Engl J Med 2006;355:2203-16.
    11/2006
    Bivalirudin Started during Emergency Transport for Primary PCI

    BACKGROUND: Bivalirudin, as compared with heparin and glycoprotein IIb/IIIa inhibitors, has been shown to reduce rates of bleeding and death in patients undergoing primary percutaneous coronary intervention (PCI). Whether these benefits persist in contemporary practice characterized by prehospital initiation of treatment, optional use of glycoprotein IIb/IIIa inhibitors and novel P2Y12 inhibitors, and radial-artery PCI access use is unknown.

    METHODS: We randomly assigned 2218 patients with ST-segment elevation myocardial infarction (STEMI) who were being transported for primary PCI to receive either bivalirudin or unfractionated or low-molecular-weight heparin with optional glycoprotein IIb/IIIa inhibitors (control group). The primary outcome at 30 days was a composite of death or major bleeding not associated with coronary-artery bypass grafting (CABG), and the principal secondary outcome was a composite of death, reinfarction, or non-CABG major bleeding.

    RESULTS: Bivalirudin, as compared with the control intervention, reduced the risk of the primary outcome (5.1% vs. 8.5%; relative risk, 0.60; 95% confidence interval [CI], 0.43 to 0.82; P=0.001) and the principal secondary outcome (6.6% vs. 9.2%; relative risk, 0.72; 95% CI, 0.54 to 0.96; P=0.02). Bivalirudin also reduced the risk of major bleeding (2.6% vs. 6.0%; relative risk, 0.43; 95% CI, 0.28 to 0.66; P<0.001). The risk of acute stent thrombosis was higher with bivalirudin (1.1% vs. 0.2%; relative risk, 6.11; 95% CI, 1.37 to 27.24; P=0.007). There was no significant difference in rates of death (2.9% vs. 3.1%) or reinfarction (1.7% vs. 0.9%). Results were consistent across subgroups of patients.

    CONCLUSIONS: Bivalirudin, started during transport for primary PCI, improved 30-day clinical outcomes with a reduction in major bleeding but with an increase in acute stent thrombosis.

    Steg PG, Van't Hof A, Hamm CW et al; EUROMAX Investigators.
    N Engl J Med 2013;369:2207-17.
    12/2013
    Bivalirudin during primary PCI in acute myocardial infarction

    BACKGROUND: Treatment with the direct thrombin inhibitor bivalirudin, as compared with heparin plus glycoprotein IIb/IIIa inhibitors, results in similar suppression of ischemia while reducing hemorrhagic complications in patients with stable angina and non-ST-segment elevation acute coronary syndromes who are undergoing percutaneous coronary intervention (PCI). The safety and efficacy of bivalirudin in high-risk patients are unknown.

    METHODS: We randomly assigned 3602 patients with ST-segment elevation myocardial infarction who presented within 12 hours after the onset of symptoms and who were undergoing primary PCI to treatment with heparin plus a glycoprotein IIb/IIIa inhibitor or to treatment with bivalirudin alone. The two primary end points of the study were major bleeding and combined adverse clinical events, defined as the combination of major bleeding or major adverse cardiovascular events, including death, reinfarction, target-vessel revascularization for ischemia, and stroke (hereinafter referred to as net adverse clinicalevents) within 30 days.

    RESULTS: Anticoagulation with bivalirudin alone, as compared with heparin plus glycoprotein IIb/IIIa inhibitors, resulted in a reduced 30-day rate of net adverse clinical events (9.2% vs. 12.1%; relative risk, 0.76; 95% confidence interval [CI] 0.63 to 0.92; P=0.005), owing to a lower rate of major bleeding (4.9% vs. 8.3%; relative risk, 0.60; 95% CI, 0.46 to 0.77; P<0.001). There was an increased risk of acute stent thrombosis within 24 hours in the bivalirudin group, but no significant increase was present by 30 days. Treatment with bivalirudin alone, as compared with heparin plus glycoprotein IIb/IIIa inhibitors, resulted in significantly lower 30-day rates of death from cardiac causes (1.8% vs. 2.9%; relative risk, 0.62; 95% CI, 0.40 to 0.95; P=0.03) and death from all causes (2.1% vs. 3.1%; relative risk, 0.66; 95% CI, 0.44 to 1.00; P=0.047).

    CONCLUSIONS: In patients with ST-segment elevation myocardial infarction who are undergoing primary PCI, anticoagulation with bivalirudin alone, as compared with heparin plus glycoprotein IIb/IIIa inhibitors, results in significantly reduced 30-day rates of major bleeding and net adverse clinical events.

    Stone GW, Witzenbichler B, Guagliumi G et al; for the HORIZONS-AMI Trial Investigators.
    N Engl J Med. 2008 May 22;358(21):2218-30.
    01/2008

    Noticias

    Última modificación: 19/09/2016