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    "titulo" => "Coment&#225;rio a &#171;Preven&#231;&#227;o da hemorragia em doentes com fibrilha&#231;&#227;o auricular submetidos a interven&#231;&#227;o coron&#225;ria percut&#226;nea &#40;estudo PIONEER&#41;&#187;"
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall"><elsevierMultimedia ident="tb0005"></elsevierMultimedia></p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Abstract</span><p id="par0020" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Background&#58;</span> In patients with atrial fibrillation undergoing percutaneous coronary intervention &#40;PCI&#41; with placement of stents&#44; standard anticoagulation with a vitamin K antagonista plus dual antiplatelet therapy &#40;DAPT&#41; with a P2Y12 inhibitor and aspirin reduces the risk of thrombosis and stroke but increases the risk of bleeding&#46; The effectiveness and safety of anticoagulation with rivaroxaban plus either one or two antiplatelet agents are uncertain&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Methods&#58;</span> We randomly assigned 2124 participants with nonvalvular atrial fibrillation who had undergone PCI with stenting to receive&#44; in a 1&#58;1&#58;1 ratio&#44; low&#8208;dose rivaroxaban &#40;15<span class="elsevierStyleHsp" style=""></span>mg once daily&#41; plus a P2Y12 inhibitor for 12 months &#40;group 1&#41;&#44; very&#8208;low&#8208;dose rivaroxaban &#40;2&#46;5<span class="elsevierStyleHsp" style=""></span>mg twice daily&#41; plus DAPT for 1&#44; 6&#44; or 12 months &#40;group 2&#41;&#44; or standard therapy with a dose&#8208;adjusted vitamin K antagonist &#40;once daily&#41; plus DAPT for 1&#44; 6&#44; or 12 months &#40;group 3&#41;&#46; The primary safety outcome was clinically significant bleeding &#40;a composite of major bleeding or minor bleeding according to Thrombolysis in Myocardial Infarction &#91;TIMI&#93; criteria or bleeding requiring medical attention&#41;&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Results&#58;</span> The rates of clinically significant bleeding were lower in the two groups receiving rivaroxaban than in the group receiving standard therapy &#40;16&#46;8&#37; in group 1&#44; 18&#46;0&#37; in group 2&#44; and 26&#46;7&#37; in group 3&#59; hazard ratio for group 1 vs&#46; group 3&#44; 0&#46;59&#59; 95&#37; confidence interval &#91;CI&#93;&#44; 0&#46;47 to 0&#46;76&#59; P<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;001&#59; hazard ratio for group 2 vs&#46; Group 3&#44; 0&#46;63&#59; 95&#37; CI&#44; 0&#46;50 to 0&#46;80&#59; P<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;001&#41;&#46; The rates of death from cardiovascular causes&#44; myocardial infarction&#44; or stroke were similar in the three groups &#40;Kaplan&#8211;Meier estimates&#44; 6&#46;5&#37; in group 1&#44; 5&#46;6&#37; in group 2&#44; and 6&#46;0&#37; in group 3&#59; P values for all comparisons were nonsignificant&#41;&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Conclusions&#58;</span> In participants with atrial fibrillation undergoing PCI with placement of stents&#44; the administration of either low&#8208;dose rivaroxaban plus a P2Y12 inhibitor for 12 months or very&#8208;low&#8208;dose rivaroxaban plus DAPT for 1&#44; 6&#44; or 12 months was associated with a lower rate of clinically significant bleeding than was standard therapy with a vitamin K antagonist plus DAPT for 1&#44; 6&#44; or 12 months&#46; The three groups had similar efficacy rates&#44; although the observed broad confidence intervals diminish the surety of any conclusions regarding efficacy&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Coment&#225;rio</span><p id="par0040" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleDisplayedQuote" id="dsq0005"><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">&#8220;Now this is not the end&#46; It is not even the beginning of the end&#46; But it is&#44; perhaps&#44; the end of the beginning&#8221;&#46;</p><span class="elsevierStyleSource">Winston Churchill&#44; novembro 1942&#46;</span></span></p><p id="par0045" class="elsevierStylePara elsevierViewall">O tratamento do doente com fibrilha&#231;&#227;o auricular submetido a interven&#231;&#227;o coron&#225;ria percut&#226;nea permanece um dos maiores desafios da cardiologia contempor&#226;nea&#46; As atuais recomenda&#231;&#245;es aconselham a utiliza&#231;&#227;o de terap&#234;utica antitromb&#243;tica tripla&#44; por um per&#237;odo de tempo vari&#225;vel&#44; conforme a apresenta&#231;&#227;o cl&#237;nica do doente e o tipo de <span class="elsevierStyleItalic">stent</span> implantado<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">1</span></a>&#46; Contudo&#44; a evid&#234;ncia para a utiliza&#231;&#227;o da terap&#234;utica tripla &#233; emp&#237;rica e&#44; por isso&#44; estas recomenda&#231;&#245;es n&#227;o s&#227;o baseadas em evid&#234;ncia&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">Sabemos hoje que a terap&#234;utica antitromb&#243;tica tripla n&#227;o &#233; in&#243;cua&#44; levando a um aumento marcado do risco relativo de hemorragia fatal e n&#227;o fatal&#44; com uma taxa de hemorragias de 22&#44;6 por 100 pessoas&#8208;ano<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">2</span></a>&#46; Mesmo a utiliza&#231;&#227;o de terap&#234;utica tripla durante um curto per&#237;odo de tempo &#40;por exemplo&#44; um m&#234;s&#41; n&#227;o &#233; segura&#44; uma vez que a maioria destas hemorragias ocorrem logo no primeiro m&#234;s ap&#243;s a introdu&#231;&#227;o da terap&#234;utica tripla<a class="elsevierStyleCrossRefs" href="#bib0055"><span class="elsevierStyleSup">2&#44;3</span></a>&#44; que assim exerce o efeito de um teste de <span class="elsevierStyleItalic">stress</span> hemorr&#225;gico&#46; Apesar de tradicionalmente os cardiologistas n&#227;o estarem muito preocupados com os riscos da hemorragia&#44; que encaravam como eventos &#171;trat&#225;veis&#187;&#44; sabemos hoje que a hemorragia piora significativamente o progn&#243;stico&#44; podendo aumentar a mortalidade cerca de cinco vezes<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">4</span></a>&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">Recentemente&#44; o paradigma do tratamento destes doentes come&#231;ou a mudar ap&#243;s dois importantes ensaios cl&#237;nicos&#58; o ISAR&#8208;TRIPLE<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">3</span></a> e o WOEST<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">5</span></a>&#46; Estes estudos mostraram&#44; pela primeira vez&#44; que a terap&#234;utica dupla &#40;antiagregante plaquet&#225;rio<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>hipocoagula&#231;&#227;o com antagonista da vitamina K&#41; reduzia de forma marcada o risco de hemorragia&#44; mantendo aparentemente a mesma efic&#225;cia&#46; Apesar de nenhum destes estudos ter poder estat&#237;stico para avaliar eventos tromb&#243;ticos&#44; observou&#8208;se tamb&#233;m uma tend&#234;ncia para a redu&#231;&#227;o dos eventos cardiovasculares<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">6</span></a> e da mortalidade total<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">5</span></a>&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">O rec&#233;m&#8208;publicado estudo PIONEER<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">7</span></a> traz nova informa&#231;&#227;o clinicamente relevante&#44; que ir&#225; certamente alterar a forma como tratamos estes doentes&#46; Em resumo&#44; mostrou que comparativamente &#224; terap&#234;utica tripla cl&#225;ssica&#44; a utiliza&#231;&#227;o de um regime de rivaroxaban 15<span class="elsevierStyleHsp" style=""></span>mg<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>clopidogrel 75<span class="elsevierStyleHsp" style=""></span>mg&#44; ou de um regime de aspirina 100<span class="elsevierStyleHsp" style=""></span>mg<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>clopidogrel 75<span class="elsevierStyleHsp" style=""></span>mg<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>rivaroxaban 2&#44;5<span class="elsevierStyleHsp" style=""></span>mg 2<span class="elsevierStyleHsp" style=""></span>id estava associada a uma redu&#231;&#227;o marcada das complica&#231;&#245;es hemorr&#225;gicas&#44; com um <span class="elsevierStyleItalic">number needed to treat</span> para prevenir um evento hemorr&#225;gico de apenas 11 e 12 doentes&#44; respetivamente&#46; Apesar de n&#227;o ser um estudo com poder estat&#237;stico para analisar efic&#225;cia &#40;apenas para seguran&#231;a&#41;&#44; n&#227;o se observou um aumento significativo do risco de eventos cardiovasculares &#40;MACE&#41; com a simplifica&#231;&#227;o do regime terap&#234;utico&#46; Al&#233;m disso&#44; numa suban&#225;lise deste estudo entretanto publicada<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">8</span></a>&#44; observou&#8208;se uma redu&#231;&#227;o das hospitaliza&#231;&#245;es de causa cardiovascular&#44; para al&#233;m da redu&#231;&#227;o das hospitaliza&#231;&#245;es por hemorragia&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">Dada a relev&#226;ncia destes resultados&#44; importa discutir a sua aplica&#231;&#227;o na pr&#225;tica cl&#237;nica&#46; Em primeiro lugar&#44; este ensaio cl&#237;nico mostra&#44; uma vez mais&#44; que a terap&#234;utica antitromb&#243;tica tripla cl&#225;ssica se associa um risco muito elevado de hemorragia &#40;26&#44;7&#37;&#41;<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">7</span></a>&#46; Observou&#8208;se tamb&#233;m neste estudo que&#44; mesmo um curto per&#237;odo de terap&#234;utica tripla &#40;por exemplo&#44; um m&#234;s&#41;&#44; se associa a um aumento significativo da hemorragia&#44; ocorrendo uma diverg&#234;ncia das curvas logo ao fim de alguns dias de utiliza&#231;&#227;o da terap&#234;utica&#46; Deste modo&#44; com base nos dados que dispomos&#44; deixa de estar aconselhada a utiliza&#231;&#227;o de terap&#234;utica tripla como rotina na grande maioria dos doentes com fibrilha&#231;&#227;o auricular submetidos a interven&#231;&#227;o coron&#225;ria percut&#226;nea&#46; Na realidade portuguesa&#44; n&#227;o dispomos atualmente da formula&#231;&#227;o de rivaroxaban 2&#44;5<span class="elsevierStyleHsp" style=""></span>mg que foi usada num dos bra&#231;os do estudo&#44; apesar dos dados promissores tamb&#233;m demonstrados nos estudos ATLAS ACS&#8208;2 TIMI51 e COMPASS&#46; Por isso&#44; a implementa&#231;&#227;o destes dados na pr&#225;tica cl&#237;nica passar&#225; pela utiliza&#231;&#227;o da combina&#231;&#227;o rivaroxaban 15<span class="elsevierStyleHsp" style=""></span>mg<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>clopidogrel 75<span class="elsevierStyleHsp" style=""></span>mg&#46; De recordar que&#44; em caso de altera&#231;&#227;o da fun&#231;&#227;o renal &#40;<span class="elsevierStyleItalic">clearance</span><span class="elsevierStyleHsp" style=""></span>da creatinina 30&#8208;50<span class="elsevierStyleHsp" style=""></span>ml&#47;min&#41;&#44; a dose de rivaroxaban dever&#225; ser reduzida para 10<span class="elsevierStyleHsp" style=""></span>mg&#44; numa toma &#250;nica di&#225;ria e que este estudo excluiu os doentes com <span class="elsevierStyleItalic">clearance</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>30<span class="elsevierStyleHsp" style=""></span>m&#47;min&#46; Este estudo incluiu um n&#250;mero muito reduzido de doentes com outros antiplaquet&#225;rios &#40;5&#44;6&#37;&#41;&#44; nomeadamente com ticagrelor ou prasugrel&#44; pelo que n&#227;o se podem extrapolar os dados para estes regimes terap&#234;uticos&#46; Finalmente&#44; em casos selecionados de angioplastias complexas haver&#225; certamente lugar para a individualiza&#231;&#227;o da terap&#234;utica&#44; podendo ser necess&#225;ria uma intensifica&#231;&#227;o transit&#243;ria do tratamento antitromb&#243;tico&#46;</p><p id="par0070" class="elsevierStylePara elsevierViewall">Est&#227;o atualmente em curso mais tr&#234;s estudos de grande dimens&#227;o&#44; que v&#227;o tamb&#233;m avaliar esta quest&#227;o da redu&#231;&#227;o do n&#250;mero de agentes antitromb&#243;ticos neste grupo de doentes&#58; o estudo RE&#8208;DUAL PCI &#40;com dabigatran&#41;&#44; o estudo AUGUSTUS &#40;com apixaban&#41; e o ENTRUST&#8208;AF&#8208;PCI &#40;com edoxaban&#41;&#46; Curiosamente&#44; todos eles ser&#227;o estudos de seguran&#231;a e nenhum ter&#225; poder estat&#237;stico para avaliar efic&#225;cia<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">9</span></a>&#46;</p><p id="par0075" class="elsevierStylePara elsevierViewall">Em conclus&#227;o&#44; com base na evid&#234;ncia atual&#44; a maioria dos doentes com fibrilha&#231;&#227;o auricular submetidos a interven&#231;&#227;o coron&#225;ria percut&#226;nea poder&#225; ser tratada de forma eficaz e segura com o regime rivaroxaban 15<span class="elsevierStyleHsp" style=""></span>mg<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>clopidogrel 75<span class="elsevierStyleHsp" style=""></span>mg&#44; durante o primeiro ano&#46; Aguardamos com expetativa os dados dos outros estudos&#44; mas claramente&#44; como dizia Winston Churchill&#44; este n&#227;o ser&#225; o fim desta hist&#243;ria&#44; mas &#233; o fim do in&#237;cio de uma nova era no tratamento do doente com fibrilha&#231;&#227;o auricular e doen&#231;a coron&#225;ria&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Conflito de interesses</span><p id="par0080" class="elsevierStylePara elsevierViewall">RFC recebeu honor&#225;rios de orador da Bayer&#44; BMS&#47;Pfizer&#44; Daiichi&#8208;Sankyo e Boehringer&#8208;Ingelheim&#46;</p></span></span>"
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          "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0010" class="elsevierStylePara elsevierViewall">C&#46; Michael Gibson&#44; Roxana Mehran&#44; Christoph Bode&#44; Jonathan Halperin&#44; Freek W&#46; Verheugt&#44; Peter Wildgoose&#44; Mary Birmingham&#44; Juliana Ianus&#44; Paul Burton&#44; Martin van Eickels&#44; Serge Korjian&#44; Yazan Daaboul&#44; Gregory Y&#46;H&#46; Lip&#44; Marc Cohen&#44; Steen Husted&#44; Eric D&#46; Peterson&#44; Keith A&#46; Fox&#46; N Engl J Med&#46; 2016&#59;375&#58;2423&#8208;34</p></span>"
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Artigo Recomendado do Mês
Comentário a «Prevenção da hemorragia em doentes com fibrilhação auricular submetidos a intervenção coronária percutânea (estudo PIONEER)»
Comment on “Prevention of bleeding in patients with atrial fibrillation undergoing PCI”
Ricardo Fontes Carvalhoa,b,c
a Serviço de Cardiologia, Centro Hospitalar de Vila Nova de Gaia/Espinho, Vila Nova de Gaia, Portugal
b Serviço de Cirurgia e Fisiologia, Faculdade de Medicina do Porto, Porto, Portugal
c Membro do Corpo Redatorial da Revista Portuguesa de Cardiologia, Portugal
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall"><elsevierMultimedia ident="tb0005"></elsevierMultimedia></p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Abstract</span><p id="par0020" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Background&#58;</span> In patients with atrial fibrillation undergoing percutaneous coronary intervention &#40;PCI&#41; with placement of stents&#44; standard anticoagulation with a vitamin K antagonista plus dual antiplatelet therapy &#40;DAPT&#41; with a P2Y12 inhibitor and aspirin reduces the risk of thrombosis and stroke but increases the risk of bleeding&#46; The effectiveness and safety of anticoagulation with rivaroxaban plus either one or two antiplatelet agents are uncertain&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Methods&#58;</span> We randomly assigned 2124 participants with nonvalvular atrial fibrillation who had undergone PCI with stenting to receive&#44; in a 1&#58;1&#58;1 ratio&#44; low&#8208;dose rivaroxaban &#40;15<span class="elsevierStyleHsp" style=""></span>mg once daily&#41; plus a P2Y12 inhibitor for 12 months &#40;group 1&#41;&#44; very&#8208;low&#8208;dose rivaroxaban &#40;2&#46;5<span class="elsevierStyleHsp" style=""></span>mg twice daily&#41; plus DAPT for 1&#44; 6&#44; or 12 months &#40;group 2&#41;&#44; or standard therapy with a dose&#8208;adjusted vitamin K antagonist &#40;once daily&#41; plus DAPT for 1&#44; 6&#44; or 12 months &#40;group 3&#41;&#46; The primary safety outcome was clinically significant bleeding &#40;a composite of major bleeding or minor bleeding according to Thrombolysis in Myocardial Infarction &#91;TIMI&#93; criteria or bleeding requiring medical attention&#41;&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Results&#58;</span> The rates of clinically significant bleeding were lower in the two groups receiving rivaroxaban than in the group receiving standard therapy &#40;16&#46;8&#37; in group 1&#44; 18&#46;0&#37; in group 2&#44; and 26&#46;7&#37; in group 3&#59; hazard ratio for group 1 vs&#46; group 3&#44; 0&#46;59&#59; 95&#37; confidence interval &#91;CI&#93;&#44; 0&#46;47 to 0&#46;76&#59; P<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;001&#59; hazard ratio for group 2 vs&#46; Group 3&#44; 0&#46;63&#59; 95&#37; CI&#44; 0&#46;50 to 0&#46;80&#59; P<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;001&#41;&#46; The rates of death from cardiovascular causes&#44; myocardial infarction&#44; or stroke were similar in the three groups &#40;Kaplan&#8211;Meier estimates&#44; 6&#46;5&#37; in group 1&#44; 5&#46;6&#37; in group 2&#44; and 6&#46;0&#37; in group 3&#59; P values for all comparisons were nonsignificant&#41;&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Conclusions&#58;</span> In participants with atrial fibrillation undergoing PCI with placement of stents&#44; the administration of either low&#8208;dose rivaroxaban plus a P2Y12 inhibitor for 12 months or very&#8208;low&#8208;dose rivaroxaban plus DAPT for 1&#44; 6&#44; or 12 months was associated with a lower rate of clinically significant bleeding than was standard therapy with a vitamin K antagonist plus DAPT for 1&#44; 6&#44; or 12 months&#46; The three groups had similar efficacy rates&#44; although the observed broad confidence intervals diminish the surety of any conclusions regarding efficacy&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Coment&#225;rio</span><p id="par0040" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleDisplayedQuote" id="dsq0005"><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">&#8220;Now this is not the end&#46; It is not even the beginning of the end&#46; But it is&#44; perhaps&#44; the end of the beginning&#8221;&#46;</p><span class="elsevierStyleSource">Winston Churchill&#44; novembro 1942&#46;</span></span></p><p id="par0045" class="elsevierStylePara elsevierViewall">O tratamento do doente com fibrilha&#231;&#227;o auricular submetido a interven&#231;&#227;o coron&#225;ria percut&#226;nea permanece um dos maiores desafios da cardiologia contempor&#226;nea&#46; As atuais recomenda&#231;&#245;es aconselham a utiliza&#231;&#227;o de terap&#234;utica antitromb&#243;tica tripla&#44; por um per&#237;odo de tempo vari&#225;vel&#44; conforme a apresenta&#231;&#227;o cl&#237;nica do doente e o tipo de <span class="elsevierStyleItalic">stent</span> implantado<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">1</span></a>&#46; Contudo&#44; a evid&#234;ncia para a utiliza&#231;&#227;o da terap&#234;utica tripla &#233; emp&#237;rica e&#44; por isso&#44; estas recomenda&#231;&#245;es n&#227;o s&#227;o baseadas em evid&#234;ncia&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">Sabemos hoje que a terap&#234;utica antitromb&#243;tica tripla n&#227;o &#233; in&#243;cua&#44; levando a um aumento marcado do risco relativo de hemorragia fatal e n&#227;o fatal&#44; com uma taxa de hemorragias de 22&#44;6 por 100 pessoas&#8208;ano<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">2</span></a>&#46; Mesmo a utiliza&#231;&#227;o de terap&#234;utica tripla durante um curto per&#237;odo de tempo &#40;por exemplo&#44; um m&#234;s&#41; n&#227;o &#233; segura&#44; uma vez que a maioria destas hemorragias ocorrem logo no primeiro m&#234;s ap&#243;s a introdu&#231;&#227;o da terap&#234;utica tripla<a class="elsevierStyleCrossRefs" href="#bib0055"><span class="elsevierStyleSup">2&#44;3</span></a>&#44; que assim exerce o efeito de um teste de <span class="elsevierStyleItalic">stress</span> hemorr&#225;gico&#46; Apesar de tradicionalmente os cardiologistas n&#227;o estarem muito preocupados com os riscos da hemorragia&#44; que encaravam como eventos &#171;trat&#225;veis&#187;&#44; sabemos hoje que a hemorragia piora significativamente o progn&#243;stico&#44; podendo aumentar a mortalidade cerca de cinco vezes<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">4</span></a>&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">Recentemente&#44; o paradigma do tratamento destes doentes come&#231;ou a mudar ap&#243;s dois importantes ensaios cl&#237;nicos&#58; o ISAR&#8208;TRIPLE<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">3</span></a> e o WOEST<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">5</span></a>&#46; Estes estudos mostraram&#44; pela primeira vez&#44; que a terap&#234;utica dupla &#40;antiagregante plaquet&#225;rio<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>hipocoagula&#231;&#227;o com antagonista da vitamina K&#41; reduzia de forma marcada o risco de hemorragia&#44; mantendo aparentemente a mesma efic&#225;cia&#46; Apesar de nenhum destes estudos ter poder estat&#237;stico para avaliar eventos tromb&#243;ticos&#44; observou&#8208;se tamb&#233;m uma tend&#234;ncia para a redu&#231;&#227;o dos eventos cardiovasculares<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">6</span></a> e da mortalidade total<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">5</span></a>&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">O rec&#233;m&#8208;publicado estudo PIONEER<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">7</span></a> traz nova informa&#231;&#227;o clinicamente relevante&#44; que ir&#225; certamente alterar a forma como tratamos estes doentes&#46; Em resumo&#44; mostrou que comparativamente &#224; terap&#234;utica tripla cl&#225;ssica&#44; a utiliza&#231;&#227;o de um regime de rivaroxaban 15<span class="elsevierStyleHsp" style=""></span>mg<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>clopidogrel 75<span class="elsevierStyleHsp" style=""></span>mg&#44; ou de um regime de aspirina 100<span class="elsevierStyleHsp" style=""></span>mg<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>clopidogrel 75<span class="elsevierStyleHsp" style=""></span>mg<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>rivaroxaban 2&#44;5<span class="elsevierStyleHsp" style=""></span>mg 2<span class="elsevierStyleHsp" style=""></span>id estava associada a uma redu&#231;&#227;o marcada das complica&#231;&#245;es hemorr&#225;gicas&#44; com um <span class="elsevierStyleItalic">number needed to treat</span> para prevenir um evento hemorr&#225;gico de apenas 11 e 12 doentes&#44; respetivamente&#46; Apesar de n&#227;o ser um estudo com poder estat&#237;stico para analisar efic&#225;cia &#40;apenas para seguran&#231;a&#41;&#44; n&#227;o se observou um aumento significativo do risco de eventos cardiovasculares &#40;MACE&#41; com a simplifica&#231;&#227;o do regime terap&#234;utico&#46; Al&#233;m disso&#44; numa suban&#225;lise deste estudo entretanto publicada<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">8</span></a>&#44; observou&#8208;se uma redu&#231;&#227;o das hospitaliza&#231;&#245;es de causa cardiovascular&#44; para al&#233;m da redu&#231;&#227;o das hospitaliza&#231;&#245;es por hemorragia&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">Dada a relev&#226;ncia destes resultados&#44; importa discutir a sua aplica&#231;&#227;o na pr&#225;tica cl&#237;nica&#46; Em primeiro lugar&#44; este ensaio cl&#237;nico mostra&#44; uma vez mais&#44; que a terap&#234;utica antitromb&#243;tica tripla cl&#225;ssica se associa um risco muito elevado de hemorragia &#40;26&#44;7&#37;&#41;<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">7</span></a>&#46; Observou&#8208;se tamb&#233;m neste estudo que&#44; mesmo um curto per&#237;odo de terap&#234;utica tripla &#40;por exemplo&#44; um m&#234;s&#41;&#44; se associa a um aumento significativo da hemorragia&#44; ocorrendo uma diverg&#234;ncia das curvas logo ao fim de alguns dias de utiliza&#231;&#227;o da terap&#234;utica&#46; Deste modo&#44; com base nos dados que dispomos&#44; deixa de estar aconselhada a utiliza&#231;&#227;o de terap&#234;utica tripla como rotina na grande maioria dos doentes com fibrilha&#231;&#227;o auricular submetidos a interven&#231;&#227;o coron&#225;ria percut&#226;nea&#46; Na realidade portuguesa&#44; n&#227;o dispomos atualmente da formula&#231;&#227;o de rivaroxaban 2&#44;5<span class="elsevierStyleHsp" style=""></span>mg que foi usada num dos bra&#231;os do estudo&#44; apesar dos dados promissores tamb&#233;m demonstrados nos estudos ATLAS ACS&#8208;2 TIMI51 e COMPASS&#46; Por isso&#44; a implementa&#231;&#227;o destes dados na pr&#225;tica cl&#237;nica passar&#225; pela utiliza&#231;&#227;o da combina&#231;&#227;o rivaroxaban 15<span class="elsevierStyleHsp" style=""></span>mg<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>clopidogrel 75<span class="elsevierStyleHsp" style=""></span>mg&#46; De recordar que&#44; em caso de altera&#231;&#227;o da fun&#231;&#227;o renal &#40;<span class="elsevierStyleItalic">clearance</span><span class="elsevierStyleHsp" style=""></span>da creatinina 30&#8208;50<span class="elsevierStyleHsp" style=""></span>ml&#47;min&#41;&#44; a dose de rivaroxaban dever&#225; ser reduzida para 10<span class="elsevierStyleHsp" style=""></span>mg&#44; numa toma &#250;nica di&#225;ria e que este estudo excluiu os doentes com <span class="elsevierStyleItalic">clearance</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>30<span class="elsevierStyleHsp" style=""></span>m&#47;min&#46; Este estudo incluiu um n&#250;mero muito reduzido de doentes com outros antiplaquet&#225;rios &#40;5&#44;6&#37;&#41;&#44; nomeadamente com ticagrelor ou prasugrel&#44; pelo que n&#227;o se podem extrapolar os dados para estes regimes terap&#234;uticos&#46; Finalmente&#44; em casos selecionados de angioplastias complexas haver&#225; certamente lugar para a individualiza&#231;&#227;o da terap&#234;utica&#44; podendo ser necess&#225;ria uma intensifica&#231;&#227;o transit&#243;ria do tratamento antitromb&#243;tico&#46;</p><p id="par0070" class="elsevierStylePara elsevierViewall">Est&#227;o atualmente em curso mais tr&#234;s estudos de grande dimens&#227;o&#44; que v&#227;o tamb&#233;m avaliar esta quest&#227;o da redu&#231;&#227;o do n&#250;mero de agentes antitromb&#243;ticos neste grupo de doentes&#58; o estudo RE&#8208;DUAL PCI &#40;com dabigatran&#41;&#44; o estudo AUGUSTUS &#40;com apixaban&#41; e o ENTRUST&#8208;AF&#8208;PCI &#40;com edoxaban&#41;&#46; Curiosamente&#44; todos eles ser&#227;o estudos de seguran&#231;a e nenhum ter&#225; poder estat&#237;stico para avaliar efic&#225;cia<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">9</span></a>&#46;</p><p id="par0075" class="elsevierStylePara elsevierViewall">Em conclus&#227;o&#44; com base na evid&#234;ncia atual&#44; a maioria dos doentes com fibrilha&#231;&#227;o auricular submetidos a interven&#231;&#227;o coron&#225;ria percut&#226;nea poder&#225; ser tratada de forma eficaz e segura com o regime rivaroxaban 15<span class="elsevierStyleHsp" style=""></span>mg<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>clopidogrel 75<span class="elsevierStyleHsp" style=""></span>mg&#44; durante o primeiro ano&#46; Aguardamos com expetativa os dados dos outros estudos&#44; mas claramente&#44; como dizia Winston Churchill&#44; este n&#227;o ser&#225; o fim desta hist&#243;ria&#44; mas &#233; o fim do in&#237;cio de uma nova era no tratamento do doente com fibrilha&#231;&#227;o auricular e doen&#231;a coron&#225;ria&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Conflito de interesses</span><p id="par0080" class="elsevierStylePara elsevierViewall">RFC recebeu honor&#225;rios de orador da Bayer&#44; BMS&#47;Pfizer&#44; Daiichi&#8208;Sankyo e Boehringer&#8208;Ingelheim&#46;</p></span></span>"
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          "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0010" class="elsevierStylePara elsevierViewall">C&#46; Michael Gibson&#44; Roxana Mehran&#44; Christoph Bode&#44; Jonathan Halperin&#44; Freek W&#46; Verheugt&#44; Peter Wildgoose&#44; Mary Birmingham&#44; Juliana Ianus&#44; Paul Burton&#44; Martin van Eickels&#44; Serge Korjian&#44; Yazan Daaboul&#44; Gregory Y&#46;H&#46; Lip&#44; Marc Cohen&#44; Steen Husted&#44; Eric D&#46; Peterson&#44; Keith A&#46; Fox&#46; N Engl J Med&#46; 2016&#59;375&#58;2423&#8208;34</p></span>"
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                      "titulo" => "Bleeding in acute coronary syndromes and percutaneous coronary interventions&#58; position paper by the Working Group on Thrombosis of the European Society of Cardiology"
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                      "titulo" => "Use of clopidogrel with or without aspirin in patients taking oral anticoagulant therapy and undergoing percutaneous coronary intervention&#58; an open&#8208;label&#44; randomised&#44; controlled trial"
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                    0 => array:2 [
                      "titulo" => "When Is a Double Better Than a TRIPLE&#63;&#58; Stenting in Patients With Atrial Fibrillation"
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Article information
ISSN: 21742049
Original language: Portuguese
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Idiomas
Revista Portuguesa de Cardiologia (English edition)
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