<?xml version="1.0" encoding="ISO-8859-1"?><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance">
<front>
<journal-meta>
<journal-id>1688-0420</journal-id>
<journal-title><![CDATA[Revista Uruguaya de Cardiología]]></journal-title>
<abbrev-journal-title><![CDATA[Rev.Urug.Cardiol.]]></abbrev-journal-title>
<issn>1688-0420</issn>
<publisher>
<publisher-name><![CDATA[Sociedad Uruguaya de Cardiología]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S1688-04202024000101202</article-id>
<article-id pub-id-type="doi">10.29277/cardio.39.1.4</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Anticoagulación precoz con warfarina en pacientes sometidos a sustitución valvular aórtica por bioprótesis. Ensayo prospectivo randomizado. Análisis interino]]></article-title>
<article-title xml:lang="en"><![CDATA[Early anticoagulation with warfarin in patients undergoing bioprosthetic aortic valve replacement. Randomized prospective trial. Interim analysis]]></article-title>
<article-title xml:lang="pt"><![CDATA[Anticoagulação precoce com varfarina em pacientes submetidos à troca valvar aórtica por bioprótese. Ensaio prospectivo randomizado. Análise provisória]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Fernández]]></surname>
<given-names><![CDATA[Amparo]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Loza]]></surname>
<given-names><![CDATA[Gimena]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Arocena]]></surname>
<given-names><![CDATA[María José]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Canessa]]></surname>
<given-names><![CDATA[Martín]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Dayan]]></surname>
<given-names><![CDATA[Víctor]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
<xref ref-type="aff" rid="Aaf"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Instituto Nacional de Cirugía Cardíaca  ]]></institution>
<addr-line><![CDATA[ ]]></addr-line>
</aff>
<aff id="Af2">
<institution><![CDATA[,Hospital de Clínicas Centro Cardiovascular Universitario ]]></institution>
<addr-line><![CDATA[ ]]></addr-line>
<country>Uruguay</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>00</month>
<year>2024</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>00</month>
<year>2024</year>
</pub-date>
<volume>39</volume>
<numero>1</numero>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://www.scielo.edu.uy/scielo.php?script=sci_arttext&amp;pid=S1688-04202024000101202&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.edu.uy/scielo.php?script=sci_abstract&amp;pid=S1688-04202024000101202&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.edu.uy/scielo.php?script=sci_pdf&amp;pid=S1688-04202024000101202&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[Resumen:  Introducción: aunque las bioprótesis son menos trombogénicas que las válvulas mecánicas; la trombosis de estas es una entidad cada vez más reconocida como causa de disfunción protésica potencialmente reversible. No está definido el beneficio de la anticoagulación rutinaria versus antiagregación plaquetaria luego de la sustitución valvular aórtica (SVA) por bioprótesis. La anticoagulación precoz podría asociarse a menores gradientes transprotésicos con similar riesgo de complicaciones.  Objetivos:  el objetivo primario es determinar si existe una diferencia significativa en la variación del gradiente transprotésico medio al año de la SVA entre las dos estrategias de tratamiento antitrombótico. Los objetivos secundarios son la comparación de la variación del gradiente máximo y del área valvular aórtica, y parámetros clínicos que incluyen la Clase Funcional de la New York Heart Association, las tasas de sangrado mayor y menor y la incidencia de eventos embólicos. Este trabajo representa el análisis interino a 3 meses de un proyecto a más largo plazo, y se propone mostrar los resultados preliminares de los puntos finales previamente definidos.  Métodos: se presenta el análisis interino de un ensayo randomizado multicéntrico. Todos los pacientes sometidos a SVA por bioprótesis porcinas fueron sucesivamente reclutados en dos centros de cirugía cardíaca desde el 01/01/2019 hasta el 01/09/2019. El grupo anticoagulación recibió warfarina durante los primeros 3 meses y ambos recibieron aspirina a largo plazo. Se realizaron instancias de seguimiento clínicas y ecocardiográficas antes del alta, a los 3 meses y al año.  Resultados:  se reclutaron 107 pacientes; 46% de ellos fueron randomizados al grupo anticoagulación y 54% al grupo control. No existieron diferencias en las características basales. Tampoco existieron diferencias significativas entre ambos grupos en la variación entre el alta y los 3 meses del área valvular protésica, coeficiente de obstrucción, gradiente máximo ni gradiente medio ni en la clase funcional. En cuanto a las complicaciones, no existieron eventos embólicos y los sangrados no difirieron significativamente entre ambos grupos.  Conclusiones: la anticoagulación no modificó la variación de los gradientes transprotésicos a los 3 meses. Asimismo, no produjo mayor incidencia de efectos adversos. Todavía no está dilucidado si la anticoagulación precoz con warfarina luego de la SVA tiene impacto en los resultados a largo plazo.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[Abstract:  Introduction: although bioprostheses are less thrombogenic than mechanical valves, bioprosthesis valve thrombosis is an increasingly recognized entity that can cause potentially reversible prosthetic valve dysfunction. There is a lack of consensus whether to use anticoagulation after aortic valve replacement (AVR) or antiplatelet therapy. Our hypothesis is that early anticoagulation is associated with lower transprosthetic gradients with similar risk of complications.  Objective:  primary objective is to determine if there is a significant difference in the variation of the mean transprosthetic gradient (&#916;Gm) one year after SVA between the two antithrombotic treatment strategies. Secondary objectives are the comparison of the variation of maximum gradient and aortic valve area, and clinical parameters including NYHA functional class, major and minor bleeding rates, and the incidence of embolic events. This work represents the 3-month interim analysis of a longer-term project, and is intended to show the preliminary results of the previously defined end points.  Methods:  this is an interim analysis of a multicenter randomized trial. All patients who underwent AVR by porcine bioprostheses were successively recruited in two cardiac surgery centers in Montevideo between 01/01/2019 and 01/09/2019. The anticoagulation group received warfarin for 3 months. Both groups received aspirin. Clinical and echocardiographic follow-up consultations were performed before discharge, at 3 months, and at 1 year. Results: 107 patients were recruited, 46% were randomized to the anticoagulation group and 54% to the control group. There were no differences in baseline characteristics. There were no significant differences between the two groups in the variation between discharge and 3 months of effective orifice area, doppler velocity index, peak gradient and mean gradient. There were also no differences between both groups in functional class. Regarding complications, there were no embolic events and bleeding did not differ significantly.  Conclusions:  in this study, anticoagulation did not modify the variation of transprosthetic gradients at 3 months. Likewise, it did not produce a higher incidence of adverse effects. It remains unclear whether early anticoagulation with warfarin after AVR has an impact on long-term outcomes.]]></p></abstract>
<abstract abstract-type="short" xml:lang="pt"><p><![CDATA[Resumo:  Introdução:  embora as biopróteses sejam menos trombogênicas que as mecânicas, a trombose de biopróteses é uma entidade cada vez mais reconhecida como causa de disfunção protética potencialmente reversível. A anticoagulação de rotina após a substituição da valva aórtica por bioprótese (SVA) não está definida. Nossa hipótese é que a anticoagulação precoce está associada a menores gradientes transprotéticos com risco semelhante de complicações.  Objetivo:  o objetivo principal é determinar se há uma diferença significativa na variação do gradiente transprotético médio (&#916;Gm) um ano após SVA entre as duas estratégias de tratamento antitrombótico. Os objetivos secundários são a comparação da variação do gradiente máximo e da área valvar aórtica e parâmetros clínicos, incluindo NYHA CF, taxas de sangramento maior e menor e incidência de eventos embólicos. Este trabalho representa a análise intercalar de 3 meses de um projeto de longo prazo, e pretende mostrar os resultados preliminares dos pontos finais previamente definidos.  Métodos: apresenta-se a análise interina de um estudo multicêntrico randomizado. Todos os pacientes submetidos a SVA por biopróteses suínas foram sucessivamente recrutados em dois centros de cirurgia cardíaca em Montevidéu, durante um período de recrutamento de 1/1/2019 a 1/9/2019. O grupo de anticoagulação recebeu warfarina por 3 meses. Ambos os grupos receberam aspirina. Foram realizadas consultas médicas clínicas e ecocardiográficas antes da alta, aos 3 meses e ao 1 ano.  Resultados: foram recrutados 107 pacientes, 46% foram randomizados para o grupo anticoagulação e 54% para o grupo controle. Não houve diferenças nas características basais. Não houve diferenças significativas entre os dois grupos da variação entre alta e 3 meses na área valvar, coeficiente de obstrução, gradiente máximo ou gradiente médio. Também não houve diferenças entre os dois grupos na classe funcional. Em relação às complicações, não houve eventos embólicos e sangramentos não diferiram significativamente.  Conclusões: neste estudo, a anticoagulação não modificou a variação dos gradientes transprotéticos aos 3 meses. Da mesma forma, não produziu maior incidência de efeitos adversos. Ainda não está claro se a anticoagulação precoce com varfarina após SVA tem impacto nos resultados a longo prazo.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[SUSTITUCIÓN VALVULAR AÓRTICA]]></kwd>
<kwd lng="es"><![CDATA[BIOPRÓTESIS]]></kwd>
<kwd lng="es"><![CDATA[ANTICOAGULACIÓN]]></kwd>
<kwd lng="es"><![CDATA[TROMBOSIS DE LA BIOPRÓTESIS]]></kwd>
<kwd lng="es"><![CDATA[TROMBOEMBOLIA]]></kwd>
<kwd lng="es"><![CDATA[ECOCARDIOGRAMA]]></kwd>
<kwd lng="en"><![CDATA[AORTIC VALVE REPLACEMENT]]></kwd>
<kwd lng="en"><![CDATA[BIOPROSTHESIS]]></kwd>
<kwd lng="en"><![CDATA[ANTICOAGULATION]]></kwd>
<kwd lng="en"><![CDATA[BIOPROSTHETIC VALVE THROMBOSIS]]></kwd>
<kwd lng="en"><![CDATA[THROMBOEMBOLISM]]></kwd>
<kwd lng="en"><![CDATA[ECHOCARDIOGRAM]]></kwd>
<kwd lng="pt"><![CDATA[SUBSTITUIÇÃO VALVAR AÓRTICA]]></kwd>
<kwd lng="pt"><![CDATA[BIOPRÓTESE]]></kwd>
<kwd lng="pt"><![CDATA[ANTICOAGULAÇÃO]]></kwd>
<kwd lng="pt"><![CDATA[TROMBOSE DE BIOPRÓTESES]]></kwd>
<kwd lng="pt"><![CDATA[EVENTOS EMBÓLICOS]]></kwd>
<kwd lng="pt"><![CDATA[ECOCARDIOGRAMA]]></kwd>
</kwd-group>
</article-meta>
</front><back>
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