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  <front>
    <journal-meta>
      <journal-id journal-id-type="publisher-id">abc</journal-id>
      <journal-title-group>
        <journal-title>Arquivos Brasileiros de Cardiologia</journal-title>
        <abbrev-journal-title abbrev-type="publisher">Arq. Bras. Cardiol.</abbrev-journal-title>
      </journal-title-group>
      <issn pub-type="ppub">0066-782X</issn>
      <issn pub-type="epub">1678-4170</issn>
      <publisher>
        <publisher-name>Sociedade Brasileira de Cardiologia - SBC</publisher-name>
        <publisher-loc>S&#227;o Paulo, SP, Brazil</publisher-loc>
      </publisher>
    </journal-meta>
    <article-meta>
      <article-id pub-id-type="publisher-id" specific-use="scielo-v3">K9WK3hZgmFkMhLS9Sfv9FyC</article-id>
      <article-id pub-id-type="other">00007</article-id>
      <article-id pub-id-type="publisher-id" specific-use="scielo-v2">S0066-782X2007000500007</article-id>
      <article-id pub-id-type="publisher-id" specific-use="scielo-v1">S0066-782X(07)08800507</article-id>
      <article-id pub-id-type="doi">10.1590/S0066-782X2007000500007</article-id>
      <article-categories>
        <subj-group subj-group-type="heading">
          <subject>Artigos Originais</subject>
        </subj-group>
      </article-categories>
      <title-group>
        <article-title>Qualidade de vida ap&#243;s revasculariza&#231;&#227;o cir&#250;rgica do mioc&#225;rdio, angioplastia ou tratamento cl&#237;nico</article-title>
      </title-group>
      <contrib-group>
        <contrib contrib-type="author">
          <name>
            <surname>Takiuti</surname>
            <given-names>Myrthes Emy</given-names>
          </name>
          <xref ref-type="aff" rid="aff01"/>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Hueb</surname>
            <given-names>Whady</given-names>
          </name>
          <xref ref-type="aff" rid="aff01"/>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Hiscock</surname>
            <given-names>Shirley Borghetti</given-names>
          </name>
          <xref ref-type="aff" rid="aff01"/>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Nogueira</surname>
            <given-names>C&#233;lia Regina Sim&#245;es da Rocha</given-names>
          </name>
          <xref ref-type="aff" rid="aff01"/>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Girardi</surname>
            <given-names>Priscyla</given-names>
          </name>
          <xref ref-type="aff" rid="aff01"/>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Fernandes</surname>
            <given-names>Fabio</given-names>
          </name>
          <xref ref-type="aff" rid="aff01"/>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Favarato</surname>
            <given-names>Desiderio</given-names>
          </name>
          <xref ref-type="aff" rid="aff01"/>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Lopes</surname>
            <given-names>Neuza</given-names>
          </name>
          <xref ref-type="aff" rid="aff01"/>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Borges</surname>
            <given-names>Jorge Chiquie</given-names>
          </name>
          <xref ref-type="aff" rid="aff01"/>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>G&#243;is</surname>
            <given-names>A&#233;cio Fl&#225;vio Teixeira de</given-names>
          </name>
          <xref ref-type="aff" rid="aff01"/>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Ramires</surname>
            <given-names>Jos&#233; Antonio Franchini</given-names>
          </name>
          <xref ref-type="aff" rid="aff01"/>
        </contrib>
      </contrib-group>
      <aff id="aff01">
        <addr-line>
          <named-content content-type="city">S&#227;o Paulo</named-content>
          <named-content content-type="state">S&#227;o Paulo</named-content>
        </addr-line>
        <institution content-type="orgname">Universidade de S&#227;o Paulo</institution>
        <institution content-type="orgdiv1">FM </institution>
        <institution content-type="orgdiv2">Hospital das Cl&#237;nicas</institution>
        <country country="BR">Brazil</country>
      </aff>
      <pub-date date-type="collection" publication-format="electronic">
        <month>05</month>
        <year>2007</year>
      </pub-date>
      <volume>88</volume>
      <issue>5</issue>
      <fpage>537</fpage>
      <lpage>544</lpage>
      <history>
        <date date-type="received">
          <day>15</day>
          <month>09</month>
          <year>2006</year>
        </date>
        <date date-type="rev-recd">
          <day>15</day>
          <month>09</month>
          <year>2006</year>
        </date>
        <date date-type="accepted">
          <day>26</day>
          <month>01</month>
          <year>2007</year>
        </date>
      </history>
      <permissions>
        <license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by-nc/4.0/" xml:lang="en">
          <license-p>This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.</license-p>
        </license>
      </permissions>
      <abstract>
        <p>FUNDAMENTO: Ainda que os benef&#237;cios cl&#237;nicos das interven&#231;&#245;es coronarianas parecem confirmados, seus efeitos na qualidade de vida (QV) permanecem pouco estudados. OBJETIVO: Avaliar a qualidade de vida (QV) na doen&#231;a multiarterial coronariana em pacientes submetidos randomicamente a cirurgia, angioplastia ou tratamento cl&#237;nico. M&#201;TODOS: Foi utilizando Short-Form Health Survey (SF36) questionnaire em 483 pacientes. Desses, 161 foram revascularizados; 166 receberam angioplastia e 153 tiveram tratamento cl&#237;nico. RESULTADOS: Na interna&#231;&#227;o, 86% referiam angina; 34%, infarto; e 32% fumavam. Tratamento cl&#237;nico: 12 pacientes (7,7%) tiveram infarto agudo do mioc&#225;rdio (IAM); 24 (15,3%) receberam cirurgia; e 19 (12,1%) morreram. Al&#233;m disso, cinco (3,2%) sofreram AVC e 40 (25,6%) tinham angina. No componente mental, 64,1% melhoram e 30,8% pioram a condi&#231;&#227;o. No componente f&#237;sico, 70,5% melhoram e 27,6% pioram a condi&#231;&#227;o. Cirurgia: 13 pacientes (8,1%) tiveram IAM, dois (1,2%) receberam cirurgia; 12 (7,4%) morreram. Em adi&#231;&#227;o, nove (5,6%) sofreram AVC e 30 (18,6%) sofriam angina. No componente mental, 72,7% melhoram e 25,5% pioram a condi&#231;&#227;o. No componente f&#237;sico, 82,6% melhoram e 16,1% pioram a condi&#231;&#227;o. Angioplastia: 18 pacientes (10,9%) tiveram IAM, 51 (30,7%) receberam interven&#231;&#245;es e 18 (19,9%) morreram. Al&#233;m disso, seis (3,6%) sofreram AVC e 35 (21%) relatavam angina. No componente mental, 66,9% melhoram e 26,5% pioram a condi&#231;&#227;o No componente f&#237;sico, 77,1% melhoram e 20,5% pioram a condi&#231;&#227;o. CONCLUS&#195;O: Observou-se melhora em todos os dom&#237;nios e nas tr&#234;s op&#231;&#245;es terap&#234;uticas. Comparativamente, a cirurgia ofereceu melhor qualidade de vida ap&#243;s quatro anos de seguimento.</p>
      </abstract>
      <kwd-group xml:lang="pt" kwd-group-type="author-generated">
        <kwd>Qualidade de vida</kwd>
        <kwd>doen&#231;a arterial coronariana</kwd>
        <kwd>angina de peito</kwd>
        <kwd>angioplastia</kwd>
        <kwd>revasculariza&#231;&#227;o mioc&#225;rdica</kwd>
      </kwd-group>
      <pub-date publication-format="electronic" date-type="pub">
        <day>15</day>
        <month>06</month>
        <year>2007</year>
      </pub-date>
    </article-meta>
  </front>
  <body>
    <p>
      <bold>ARTIGO ORIGINAL</bold>
    </p>
    <p>
      <bold>Qualidade de vida ap&#243;s revasculariza&#231;&#227;o cir&#250;rgica do mioc&#225;rdio, angioplastia ou tratamento cl&#237;nico</bold>
    </p>
    <p>
      <bold>Myrthes Emy Takiuti; Whady Hueb; Shirley Borghetti Hiscock; C&#233;lia Regina Sim&#245;es da Rocha Nogueira; Priscyla Girardi; Fabio Fernandes; Desiderio Favarato; Neuza Lopes; Jorge Chiquie Borges; A&#233;cio Fl&#225;vio Teixeira de G&#243;is; Jos&#233; Antonio Franchini Ramires</bold>
    </p>
    <p>Instituto do Cora&#231;&#227;o do Hospital das Cl&#237;nicas - FMUSP - S&#227;o Paulo, SP</p>
    <p>
      <xref ref-type="corresp" rid="end">Correspond&#234;ncia</xref>
    </p>
    <p>
      <bold>RESUMO</bold>
    </p>
    <p><bold>FUNDAMENTO: </bold>Ainda que os benef&#237;cios cl&#237;nicos das interven&#231;&#245;es coronarianas parecem confirmados, seus efeitos na qualidade de vida (QV) permanecem pouco estudados. </p>
    <p><bold>OBJETIVO: </bold>Avaliar a qualidade de vida (QV) na doen&#231;a multiarterial coronariana em pacientes submetidos randomicamente a cirurgia, angioplastia ou tratamento cl&#237;nico. </p>
    <p><bold>M&#201;TODOS: </bold>Foi utilizando <italic>Short-Form Health Survey (SF36) questionnaire</italic> em 483 pacientes. Desses, 161 foram revascularizados; 166 receberam angioplastia e 153 tiveram tratamento cl&#237;nico. </p>
    <p><bold>RESULTADOS: </bold>Na interna&#231;&#227;o, 86% referiam angina; 34%, infarto; e 32% fumavam. Tratamento cl&#237;nico: 12 pacientes (7,7%) tiveram infarto agudo do mioc&#225;rdio (IAM); 24 (15,3%) receberam cirurgia; e 19 (12,1%) morreram. Al&#233;m disso, cinco (3,2%) sofreram AVC e 40 (25,6%) tinham angina. No componente mental, 64,1% melhoram e 30,8% pioram a condi&#231;&#227;o. No componente f&#237;sico, 70,5% melhoram e 27,6% pioram a condi&#231;&#227;o. Cirurgia: 13 pacientes (8,1%) tiveram IAM, dois (1,2%) receberam cirurgia; 12 (7,4%) morreram. Em adi&#231;&#227;o, nove (5,6%) sofreram AVC e 30 (18,6%) sofriam angina. No componente mental, 72,7% melhoram e 25,5% pioram a condi&#231;&#227;o. No componente f&#237;sico, 82,6% melhoram e 16,1% pioram a condi&#231;&#227;o. Angioplastia: 18 pacientes (10,9%) tiveram IAM, 51 (30,7%) receberam interven&#231;&#245;es e 18 (19,9%) morreram. Al&#233;m disso, seis (3,6%) sofreram AVC e 35 (21%) relatavam angina. No componente mental, 66,9% melhoram e 26,5% pioram a condi&#231;&#227;o No componente f&#237;sico, 77,1% melhoram e 20,5% pioram a condi&#231;&#227;o. </p>
    <p><bold>CONCLUS&#195;O: </bold>Observou-se melhora em todos os dom&#237;nios e nas tr&#234;s op&#231;&#245;es terap&#234;uticas. Comparativamente, a cirurgia ofereceu melhor qualidade de vida ap&#243;s quatro anos de seguimento.</p>
    <p><bold>Palavras-chave: </bold>Qualidade de vida, doen&#231;a arterial coronariana, angina de peito, angioplastia, revasculariza&#231;&#227;o mioc&#225;rdica.</p>
    <p>
      <bold>Introdu&#231;&#227;o</bold>
    </p>
    <p>Estudos recentes sobre qualidade de vida (QV) t&#234;m sido realizados em pacientes portadores de v&#225;rias condi&#231;&#245;es m&#243;rbidas objetivando aferir as diferentes medidas terap&#234;uticas destinadas a melhorar as condi&#231;&#245;es cl&#237;nicas e tamb&#233;m a qualidade de vida dos pacientes<sup>1</sup>. Inclu&#237;da nessa condi&#231;&#227;o, a doen&#231;a arterial coronariana (DAC), considerada uma das mais importantes causas de morbidade e mortalidade na popula&#231;&#227;o adulta, tem um cen&#225;rio com probabilidades de n&#227;o se modificar nos pr&#243;ximos anos<sup>2</sup>.</p>
    <p>Enfermidade baseada em fatores de risco pass&#237;veis de modifica&#231;&#245;es, tais como dislipemia, tabagismo, diabete melito e hipertens&#227;o arterial, a DAC pode sofrer interven&#231;&#245;es em sua trajet&#243;ria e com isso reduzir a probabilidade de risco de um evento coronariano e, conseq&#252;entemente, melhorar a (QV) dos pacientes<sup>3</sup>.</p>
    <p>Essas interven&#231;&#245;es contribuem, por um lado, com um aumento da sobreviv&#234;ncia, e, por outro, com o prolongamento das poss&#237;veis co-morbidades desencadeadas por essa doen&#231;a<sup>4,5</sup>. Assim essas a&#231;&#245;es poder&#227;o interferir no estado emocional, f&#237;sico, social e, principalmente, na qualidade de vida como um todo. Al&#233;m disso, o uso continuado de medicamentos, tais como o &#225;cido acetilsalis&#237;lico, os betabloqueadores, as estatinas e os inibidores da enzima conversora da angiotensina, &#233; exemplo de interven&#231;&#227;o capaz de interferir no prolongamento das poss&#237;veis co-morbidades cardiovasculares<sup>6-8</sup>. Dessa forma, com o crescimento da popula&#231;&#227;o idosa e com o aumento da longevidade, as doen&#231;as do aparelho circulat&#243;rio continuar&#227;o a liderar o progressivo surgimento de diferentes formas de interven&#231;&#245;es terap&#234;uticas e farmacol&#243;gicas empregadas para modificar essas estat&#237;sticas<sup>9,10</sup>. </p>
    <p>Estudos randomizados que objetivaram comparar os efeitos na sobreviv&#234;ncia e incid&#234;ncia de eventos cardiovasculares no tratamento da DAC, e tamb&#233;m seus efeitos na qualidade de vida em longo prazo, resultaram conclus&#245;es conflitantes<sup>11-13</sup>. Essas diferen&#231;as deveram-se principalmente pelos diferentes momentos em que foram conduzidos, pelos recursos terap&#234;uticos dispon&#237;veis e tamb&#233;m pelas diferentes ferramentas utilizadas na avalia&#231;&#227;o da qualidade de vida dos pacientes.</p>
    <p>Objetivando comparar as tr&#234;s op&#231;&#245;es terap&#234;uticas dispon&#237;veis, empregadas no controle dos sintomas da DAC, e a sua respectiva interfer&#234;ncia na qualidade de vida dos pacientes, o MASS II (The Medicine, Angioplasty or Surgery Study II) foi desenvolvido para avaliar os resultados dos principais eventos cl&#237;nicos, da sobreviv&#234;ncia em longo prazo, e da qualidade de vida de pacientes que se submeteram aos tratamentos cl&#237;nico, cirurgia ou por angioplastia<sup>14</sup>. </p>
    <p>
      <bold>M&#233;todos</bold>
    </p>
    <p>Detalhes do desenho do MASS II, protocolo de estudo, sele&#231;&#227;o de pacientes e crit&#233;rios para inclus&#227;o foram publicados previamente<sup>14</sup>. Em breve sum&#225;rio, pacientes com DAC multiarterial sintom&#225;tica documentada por meio de angiogramas, isquemia mioc&#225;rdica, relatada por meio de sintomas ou identificadas por teste ergom&#233;trico, foram considerados apropriados para inclus&#227;o. A angina de peito foi graduada pela <italic>Canadian Cardiovascular Society</italic> (CCS) (classe II ou III)<sup>15</sup>.</p>
    <p>Este estudo vem sendo desenvolvido no Instituto do Cora&#231;&#227;o (InCor) do Hospital das Cl&#237;nicas da Faculdade de Medicina da Universidade de S&#227;o Paulo (FMUSP), envolvendo a Unidade Cl&#237;nica de Coronariopatia Cr&#244;nica, e demais unidades interligadas para exames e procedimentos, com aprova&#231;&#227;o da Comiss&#227;o Cient&#237;fica do Instituto do Cora&#231;&#227;o sob o n&#186;. 946/94/56, e da Comiss&#227;o de &#201;tica do Hospital das Cl&#237;nicas da Faculdade de Medicina da Universidade de S&#227;o Paulo sob o n&#186;. 264/94/11.</p>
    <p><italic>Sele&#231;&#227;o de pacientes - </italic>No per&#237;odo de maio 1995 a maio de 2000, foram cadastrados em um banco de dados 20.769 pacientes, submetidos a cineangiocoronariografia, por apresentarem suspeita cl&#237;nica de DAC. Desse total, 18.693 pacientes foram exclu&#237;dos por n&#227;o preencherem os crit&#233;rios espec&#237;ficos do protocolo. Dos 2.076 pacientes restantes, adequados para as tr&#234;s formas habituais de tratamento, 1.465 pacientes n&#227;o foram inclu&#237;dos por n&#227;o aceitarem participar de um estudo randomizado. Os 611 pacientes restantes formaram assim a amostra do presente estudo. Os pacientes foram inclu&#237;dos e randomizados no caso de concord&#226;ncia de cirurgi&#245;es, hemodinamicistas ou m&#233;dicos cl&#237;nicos quanto &#224; possibilidade de qualquer uma das op&#231;&#245;es de tratamento. Assim foram alocados: para revasculariza&#231;&#227;o cir&#250;rgica do mioc&#225;rdio (203 pacientes), angioplastia (205 pacientes), tratamento cl&#237;nico (203 pacientes). Os participantes, ap&#243;s receberem informa&#231;&#245;es detalhadas do estudo e sanarem suas d&#250;vidas, assinaram o Termo de Consentimento Livre e Esclarecido. </p>
    <p><italic>Instrumentos - </italic>Utilizou-se o question&#225;rio gen&#233;rico de avalia&#231;&#227;o da qualidade de vida, o <italic>Medical Outcomes Study 36-Item Short-Form Health Survey</italic> (SF-36), idealizado por Ware e Sherboune<sup>16</sup> e validado para o portugu&#234;s por Ciconelli<sup>17</sup>. Esse question&#225;rio &#233; uma ferramenta que pode ser aplicada em pessoas a partir dos 12 anos de idade, e que objetiva pesquisar o estado de sa&#250;de f&#237;sica e mental na pr&#225;tica cl&#237;nica individualmente, e na popula&#231;&#227;o geral.</p>
    <p>O question&#225;rio &#233; composto por 36 quest&#245;es que abordam oito dom&#237;nios (ou dimens&#245;es) em dois grandes componentes: o componente f&#237;sico que envolve a capacidade funcional, a dor, o estado geral de sa&#250;de e o aspecto f&#237;sico. O componente mental abrange a sa&#250;de mental, o aspecto emocional, o aspecto social e a vitalidade, que &#233; avaliada por 35 quest&#245;es. Al&#233;m disso, h&#225; mais uma quest&#227;o comparativa entre a sa&#250;de atual e a do ano anterior. A finalidade das quest&#245;es foi transformar medidas subjetivas em dados objetivos, que permitissem ser analisadas de forma espec&#237;fica, global e reprodut&#237;vel (<xref ref-type="table" rid="tab01">tab. 1</xref>).</p>
    <table-wrap id="tab01">
      <graphic xlink:href="1678-4170-abc-88-05-0537-00007-gt01.jpg"/></table-wrap>
    <p>Para avalia&#231;&#227;o dos resultados, utilizou-se um escore pr&#243;prio de cada quest&#227;o, onde o escore num&#233;rico baixo reflete a m&#225; percep&#231;&#227;o da sa&#250;de, a perda da fun&#231;&#227;o e a presen&#231;a de dor, enquanto o escore num&#233;rico alto reflete a boa percep&#231;&#227;o da sa&#250;de, fun&#231;&#227;o preservada e aus&#234;ncia de dor.</p>
    <p>O SF-36 foi elaborado para ser um instrumento auto-administr&#225;vel, podendo, entretanto, ser aplicado no formato de entrevistas, Esse recurso foi aplicado em nosso estudo, visando uniformizar a conduta, visto que detectou variabilidade de escolaridade entre nossos pacientes. As entrevistas foram aplicadas na admiss&#227;o do estudo, seis, doze, 24, 36 e 48 meses de seguimento.</p>
    <p>Todas as entrevistas foram realizadas de maneira interpessoal, e pelo mesmo investigador, contudo, a aplica&#231;&#227;o do SF-36 por meio de telefonemas, entrevistas ou pela forma auto-administr&#225;vel n&#227;o revela diferen&#231;as entre os resultados obtidos em estudo pr&#233;vio<sup>18</sup>.</p>
    <p>O question&#225;rio de investiga&#231;&#227;o do perfil demogr&#225;fico abrangeu perguntas sobre escolaridade, estado conjugal, vida profissional e rela&#231;&#227;o com o trabalho. Buscou-se, tamb&#233;m, avaliar a ocorr&#234;ncia de mudan&#231;as relacionadas &#224; doen&#231;a, na esfera do trabalho, da situa&#231;&#227;o econ&#244;mica nas perspectivas profissionais, bem como a influ&#234;ncia das mudan&#231;as do ponto de vista do paciente.</p>
    <p><italic>An&#225;lise estat&#237;stica - </italic>As vari&#225;veis mensuradas em mais de uma condi&#231;&#227;o (pr&#233;-, 6, 12, 24, 36, 48 meses), foram apresentadas em gr&#225;ficos, contendo m&#233;dias e erro padr&#227;o. As m&#233;dias foram avaliadas com an&#225;lise de vari&#226;ncia para medidas repetitivas, em que as seguintes hip&#243;teses b&#225;sicas foram testadas:</p>
    <p>&#149; Ho1: Os perfis de m&#233;dias s&#227;o paralelos, ou seja, os grupos t&#234;m o mesmo comportamento; </p>
    <p>&#149; Ho2: Os perfis de m&#233;dias s&#227;o coincidentes, ou seja, n&#227;o existe efeito de grupo;</p>
    <p>&#149; Ho3: N&#227;o existe efeito de tempo, ou seja, os perfis s&#227;o paralelos ao eixo das abscissas.</p>
    <p>Para avaliar os escores no momento 48 meses utilizou-se o modelo linear generalizado. Os valores de p&lt;0,05 foram considerados estatisticamente significantes.</p>
    <p>
      <bold>Resultados</bold>
    </p>
    <p>Dos 611 pacientes randomizados que compuseram a amostra deste estudo para seguimento cl&#237;nico de longo prazo, 483 pacientes foram acompanhados para avalia&#231;&#245;es da qualidade de vida e question&#225;rio de perfil demogr&#225;fico. Esses pacientes formaram os seguintes grupos terap&#234;uticos: revasculariza&#231;&#227;o cir&#250;rgica do mioc&#225;rdio (RCM) 161 pacientes, (33,3%), angioplastia coronariana percut&#226;nea (PCI) 166 pacientes (34,3%) e tratamento m&#233;dico (TM) 153 pacientes (32,4%) sendo acompanhados periodicamente. Os 128 pacientes restantes foram exclu&#237;dos por apresentarem dificuldades no entendimento do question&#225;rio, por recusa em participar nessa pesquisa ou por morte durante o seguimento, dentre outros. O estado vital de todos os pacientes foi conclu&#237;do em maio de 2004. O tempo m&#237;nimo de dura&#231;&#227;o da pesquisa foi de quatro anos para todos os pacientes. Os grupos terap&#234;uticos formaram caracter&#237;sticas cl&#237;nicas e demogr&#225;ficas balanceadas relacionadas a importantes fatores progn&#243;sticos da enfermidade. Assim, os pacientes das tr&#234;s op&#231;&#245;es terap&#234;uticas foram similares quando relacionados &#224;s condi&#231;&#245;es cl&#237;nicas, angiogr&#225;ficas, uso de medica&#231;&#245;es, exames laboratoriais, dentre outros. Dos pacientes em seguimento, 86% apresentavam, na admiss&#227;o do estudo, sintomas anginosos classe II ou III (CCS); 34% referiram ocorr&#234;ncia de infarto do mioc&#225;rdio pr&#233;vio; 32% eram tabagistas como exposto na <xref ref-type="table" rid="tab02">tabela 2</xref>. Todos os pacientes recebiam medica&#231;&#245;es espec&#237;ficas para o comprometimento card&#237;aco e demais co-morbidades.</p>
    <table-wrap id="tab02">
      <graphic xlink:href="1678-4170-abc-88-05-0537-00007-gt02.jpg"/></table-wrap>
    <p><italic>Tratamento cl&#237;nico - </italic>Ap&#243;s o per&#237;odo de quatro anos de seguimento, dos 153 pacientes encaminhados para o tratamento cl&#237;nico, 12 (7,7%) foram vitimados de infarto agudo do mioc&#225;rdio, 24 (15,3%) foram submetidos a cirurgia de revasculariza&#231;&#227;o do mioc&#225;rdio e 19 (12,1%) evolu&#237;ram para &#243;bito. Al&#233;m disso, cinco pacientes (3,1%) sofreram epis&#243;dio de acidente vascular cerebral e 40 (25,6%) relataram sintomas de angina de peito. Em rela&#231;&#227;o &#224; qualidade de vida, observamos importantes modifica&#231;&#245;es tanto no componente f&#237;sico quanto no componente mental. Assim, no dom&#237;nio da capacidade funcional, 104 pacientes (68%) apresentaram melhora, 13 pacientes (8,5%) mantiveram-se na mesma condi&#231;&#227;o, enquanto 36 (23,5%) revelaram piora da capacidade funcional. No aspecto f&#237;sico, 74 (48,5%) pacientes apresentaram melhora, 54 (35%) mantiveram-se na mesma condi&#231;&#227;o, e 25 (16,5%) revelaram piora da condi&#231;&#227;o. Em rela&#231;&#227;o &#224; dor, 68 pacientes (44,5%) relataram melhora, 48 (25,5%) referiram piora, e 37 (24%) mantiveram-se na mesma condi&#231;&#227;o. Na avalia&#231;&#227;o do estado geral de sa&#250;de, 90 pacientes (59%) apresentaram melhora, 44 pacientes (28,5%) relataram piora, e 19 pacientes (12,5%) mantiveram a mesma condi&#231;&#227;o. </p>
    <p>Al&#233;m disso, a avalia&#231;&#227;o do estado vital revelou melhora em 87 pacientes (57%), piora em 20 pacientes (13%) e manuten&#231;&#227;o da mesma condi&#231;&#227;o nos 46 pacientes restantes (30%). O aspecto social melhorou em 74 pacientes (49%), piorou em 40 pacientes (25,5%) e manteve-se inalterado em 39 pacientes (25,5%) desse dom&#237;nio. As modifica&#231;&#245;es do aspecto emocional revelaram melhora em 63 pacientes (41%), piora em 33 pacientes (21,5%) e manuten&#231;&#227;o do quadro em 57 pacientes (37,5%). Por fim, em rela&#231;&#227;o &#224; sa&#250;de mental, observou-se melhora em 101 pacientes (66%), piora em 42 pacientes (27,5%) e inalterado em 10 pacientes (6,5%). </p>
    <p><italic>Tratamento cir&#250;rgico - </italic>Nesse per&#237;odo de seguimento, dos 161 pacientes encaminhados para o tratamento cir&#250;rgico 13 (8,1%) foram vitimados de infarto agudo do mioc&#225;rdio, cinco (3,1%) foram submetidos a revasculariza&#231;&#227;o do mioc&#225;rdio, e 12 (7,4%) evolu&#237;ram para &#243;bito. Al&#233;m disso, nove (5,6%) sofreram epis&#243;dio de acidente vascular cerebral e 30 (18,6%) relataram padecer de sintomas de angina de peito. Foram observadas, al&#233;m disso, modifica&#231;&#245;es na qualidade de vida relativas aos componentes f&#237;sico e mental. Em rela&#231;&#227;o ao dom&#237;nio capacidade funcional, 130 pacientes (83,5%) apresentaram melhora, oito pacientes (5%) mantiveram-se na mesma condi&#231;&#227;o, enquanto 18 (11,5%) revelaram piora da capacidade funcional. No aspecto f&#237;sico, 102 pacientes (65,5%) apresentaram melhora, 38 (24,5%) mantiveram-se na mesma condi&#231;&#227;o, e 16 (10 %) revelaram piora da condi&#231;&#227;o. Em rela&#231;&#227;o &#224; dor, 87 pacientes (56%) relataram melhora, 41 (26%) referiram piora, e 28 (18%) mantiveram-se na mesma condi&#231;&#227;o. Na avalia&#231;&#227;o do estado geral de sa&#250;de, 116 pacientes (74,5%) apresentaram melhora, 31 pacientes (20%) relataram piora, e 9 pacientes (5,5%) mantiveram a mesma condi&#231;&#227;o. </p>
    <p>Al&#233;m disso, a avalia&#231;&#227;o do estado vital revelou melhora em 109 pacientes (70%), piora em 36 (23%) pacientes, e manuten&#231;&#227;o da mesma condi&#231;&#227;o nos 11 pacientes restantes (7 %). O aspecto social melhorou em 94 pacientes (60%), piorou em 31 pacientes (20%), e manteve-se inalterado em 31 pacientes (20%) desse dom&#237;nio. As modifica&#231;&#245;es do aspecto emocional revelaram melhora em 82 pacientes (52,5%), piora em 25 pacientes (16%), e manuten&#231;&#227;o do quadro em 49 pacientes (31,5%). Por fim, em rela&#231;&#227;o &#224; sa&#250;de mental, observou-se melhora em 105 pacientes (67,5%), piora em 40 pacientes (25,5%) e inalterado nos 11 pacientes restantes (7%).</p>
    <p><italic>Angioplastia - </italic>Na avalia&#231;&#227;o dos quatro anos de seguimento dos 166 pacientes submetidos a angioplastia, 18 (10,9%) foram vitimados de infarto agudo do mioc&#225;rdio, 15 (9,0%) foram submetidos a revasculariza&#231;&#227;o cir&#250;rgica do mioc&#225;rdio, 36 (21,7%) foram submetidos a nova angioplastia, e 18 (10,9%) evolu&#237;ram para &#243;bito. Al&#233;m disso, seis (3,6%) foram vitimados de acidente vascular cerebral, e 35 (21%) referiram sintomas de angina de peito. Foi observado, al&#233;m disso, modifica&#231;&#245;es na qualidade de vida, relativos aos dois componentes analisados: o f&#237;sico e o mental. Assim, no dom&#237;nio da capacidade funcional, 119 pacientes (73,5%) apresentaram melhora, 13 pacientes (8%) mantiveram-se na mesma condi&#231;&#227;o, enquanto 30 (18%) revelaram piora da capacidade funcional. No aspecto f&#237;sico, 92 pacientes (57%) apresentaram melhora, 49 (30%) mantiveram-se na mesma condi&#231;&#227;o, e 21 (13%) revelaram piora da condi&#231;&#227;o. Em rela&#231;&#227;o &#224; dor, 79 (48,5%) pacientes relataram melhora, 41 (25,5%) referiram piora, e 42 (26%) mantiveram-se na mesma condi&#231;&#227;o. Na avalia&#231;&#227;o do estado geral de sa&#250;de, 102 pacientes (63%) apresentaram melhora, 42 pacientes (26%) relataram piora, e 18 pacientes (11%) mantiveram a mesma condi&#231;&#227;o. </p>
    <p>Al&#233;m disso, a avalia&#231;&#227;o do estado vital revelou melhora em 94 pacientes (58%), piora em 45 (28%), e manuten&#231;&#227;o da mesma condi&#231;&#227;o nos 23 (14%) pacientes restantes. O aspecto social melhorou em 90 pacientes (55,5%), piora em 32 pacientes (19,5%), e inalterado em 40 pacientes (25%) desse dom&#237;nio. As modifica&#231;&#245;es do aspecto emocional revelaram melhora em 76 pacientes (47%), piora em 19 pacientes (11,5%), e manuten&#231;&#227;o do quadro em 67 pacientes (41,5%). Por fim, em rela&#231;&#227;o &#224; sa&#250;de mental, observou-se melhora em 108 pacientes (67%), piora em 40 pacientes (24,5%), e inalterado nos 14 pacientes restantes (8,5%). Quando se analisaram os principais eventos cl&#237;nicos durante o seguimento de quatro anos, observou-se significativo aumento da necessidade de reinterven&#231;&#245;es nos pacientes submetidos a angioplastia; necessidade de angioplastia nos pacientes do grupo cl&#237;nico, bem como expressivo n&#250;mero de pacientes com sintomas de angina em todos os grupos terap&#234;uticos (<xref ref-type="table" rid="tab03">tab. 3</xref>). </p>
    <table-wrap id="tab03">
      <graphic xlink:href="1678-4170-abc-88-05-0537-00007-gt03.jpg"/></table-wrap>
    <p>A an&#225;lise das varia&#231;&#245;es de todos os dom&#237;nios observados na admiss&#227;o e no final do seguimento, comparando com as tr&#234;s op&#231;&#245;es terap&#234;uticas, &#233; mostrada na <xref ref-type="fig" rid="a07fig01">figura 1</xref> Al&#233;m disso, a compara&#231;&#227;o entre o tratamento cl&#237;nico com os tratamentos intervencionistas, ambos (cirurgia e angioplastia), revelou melhora significativa nos dom&#237;nios emocional, funcional, mental e estado geral (<xref ref-type="fig" rid="fig02">fig. 2</xref>). Quando se analisaram nesses mesmos tratamentos os resultados dos dois grandes componentes (o componente f&#237;sico e o componente mental), cada um com os seus quatro dom&#237;nios, encontramos significativa melhora desses componentes quando o tratamento foi intervencionista. A compara&#231;&#227;o entre o tratamento cl&#237;nico e o tratamento cir&#250;rgico revelou acentuada melhora dos oito dom&#237;nios nos pacientes submetidos a cirurgia (<xref ref-type="fig" rid="fig03">fig. 3</xref>). Foi observado, tamb&#233;m, melhora nos pacientes cir&#250;rgicos nos seus dois grandes componentes. Al&#233;m disso, quando comparamos o tratamento cir&#250;rgico com a angioplastia, observamos, com exce&#231;&#227;o do dom&#237;nio emocional, significativa vantagem do tratamento cir&#250;rgico em todos os outros dom&#237;nios (<xref ref-type="fig" rid="fig04">fig. 4</xref>). </p>
    <p content-type="asset">
      <fig id="a07fig01">
        <graphic xlink:href="1678-4170-abc-88-05-0537-00007-gf01.jpg"/></fig>
    </p>
    <fig id="fig02">
      <graphic xlink:href="1678-4170-abc-88-05-0537-00007-gf02.jpg"/></fig>
    <fig id="fig03">
      <graphic xlink:href="1678-4170-abc-88-05-0537-00007-gf03.jpg"/></fig>
    <fig id="fig04">
      <graphic xlink:href="1678-4170-abc-88-05-0537-00007-gf04.jpg"/></fig>
    <p>O mesmo comportamento foi notado nos componentes f&#237;sico e mental na compara&#231;&#227;o entre esses dois tratamentos. Por fim, quando se comparou o tratamento cl&#237;nico com a angioplastia, notou-se, com exce&#231;&#227;o do dom&#237;nio da dor, uma significativa melhora nos pacientes submetidos a angioplastia em todos os dom&#237;nios restantes (<xref ref-type="fig" rid="fig05">fig. 5</xref>). Al&#233;m disso, foi notada uma significativa melhora nos dois grandes componentes (f&#237;sico e mental) entre os pacientes submetidos a angioplastia, quando comparados com o tratamento cl&#237;nico. A an&#225;lise multivariada de co-morbidades e tamb&#233;m de dados demogr&#225;ficos, corrigidos para vari&#225;veis tais como idade, escolaridade, g&#234;nero, tabagismo, diabetes, hipertens&#227;o, infarto e estado anginoso, mostrou que, exceto no dom&#237;nio sa&#250;de mental, houve significativa melhora no final das tr&#234;s formas terap&#234;uticas aplicadas.</p>
    <fig id="fig05">
      <graphic xlink:href="1678-4170-abc-88-05-0537-00007-gf05.jpg"/></fig>
    <p>
      <bold>Discuss&#227;o</bold>
    </p>
    <p>Instrumentos de avalia&#231;&#227;o de sa&#250;de f&#237;sica ou mental s&#227;o usados para mensurar poss&#237;veis modifica&#231;&#245;es na qualidade de vida de determinadas interven&#231;&#245;es m&#233;dicas, em estudos controlados ou tamb&#233;m em estudos populacionais<sup>19</sup>. Observamos, contemporaneamente, o crescente surgimento de ensaios cl&#237;nicos planejados para avaliar, especificamente a seguran&#231;a e a efetividade de diferentes procedimentos ou t&#233;cnicas<sup>20</sup>, ou ent&#227;o testes farmacol&#243;gicos incorporando a eles, instrumentos de qualidade de vida<sup>21</sup>. Os modelos usados nessas medidas necessitam ser adequados para cada tipo de popula&#231;&#227;o, de tratamento ou de interven&#231;&#227;o, posto que o conceito de qualidade de vida pode ser aplicado de maneira especifica para mensurar os m&#250;ltiplos aspectos de sa&#250;de f&#237;sica ou mental. A maioria dos ensaios cl&#237;nicos com uso de f&#225;rmacos ou ent&#227;o de tratamento intervencionista aplica question&#225;rios auto-administr&#225;veis dispon&#237;veis para objetivos espec&#237;ficos<sup>22</sup> e outros para uma grande variedade de doen&#231;as, principalmente as cr&#244;nicas<sup>23-25</sup>.</p>
    <p>Aplicando o <italic>Medical Outcomes Study 36-Item Short-Form Helth Survey</italic> (SF-36), o presente estudo observou melhora de todos os componentes, f&#237;sico ou mental, no final do estudo. Essa melhora, entretanto, foi mais acentuada nos pacientes submetidos a cirurgia. Quando se analisaram os diferentes dom&#237;nios dos componentes f&#237;sicos ou mentais na admiss&#227;o do estudo, observou-se que os pacientes designados para o tratamento cir&#250;rgico apresentavam pior avalia&#231;&#227;o nesses quesitos em rela&#231;&#227;o aos outros tipos de tratamento. Entretanto, esse mesmo grupo de tratamento foi o que melhor qualidade de vida apresentou no final do estudo. Esse resultado confirma de maneira direta os melhores resultados da cirurgia na evolu&#231;&#227;o dos sintomas anginosos, na incid&#234;ncia de novos infartos e na necessidade de novas interven&#231;&#245;es. </p>
    <p>Ainda que o tratamento por meio da angioplastia tenha necessitado de significativo n&#250;mero de novas interven&#231;&#245;es em rela&#231;&#227;o a outros tratamentos, os pacientes desse grupo apresentaram melhora na qualidade de vida quando comparados ao tratamento cl&#237;nico no final do estudo. Por fim, pacientes que receberam somente tratamento medicamentoso tamb&#233;m melhoraram a qualidade de vida no final da avalia&#231;&#227;o. Relevante salientar que o continuado acompanhamento peri&#243;dico dos pacientes, a intensa administra&#231;&#227;o de f&#225;rmacos, o rigoroso controle dos fatores de risco em pacientes portadores de enfermidade potencialmente grave tenham contribu&#237;do para esses resultados. Nesse contexto, a manuten&#231;&#227;o da mesma equipe multiprofissional teve papel fundamental na boa evolu&#231;&#227;o dos pacientes deste estudo. Al&#233;m disso, cabe ainda salientar que o instrumento foi aplicado por meio de entrevistas, sempre pelo mesmo investigador, o que confere maior estabilidade de relacionamento entre o paciente e o profissional de sa&#250;de. </p>
    <p>Em estudos de avalia&#231;&#227;o de qualidade de vida em pacientes submetidos aos tratamentos intervencionistas (cirurgia <italic>versus</italic> angioplastia), aplicando o mesmo instrumento de qualidade de vida (SF-36), por&#233;m de maneira auto-administr&#225;vel, observou-se que ao final de tr&#234;s anos de seguimento os estados anginosos e a volta ao trabalho tiveram importante melhora nas duas formas de tratamento. Os sintomas anginosos foram menos acentuados no tratamento cir&#250;rgico do que no tratamento por angioplastia<sup>13</sup>. Contudo, a volta ao trabalho foi mais r&#225;pida nos pacientes tratados com angioplastia. </p>
    <p>Conclui-se, por fim, que houve melhora semelhante na qualidade de vida em ambas as formas terap&#234;uticas. Esse mesmo grupo de estudos avaliando pacientes submetidos a tratamento cl&#237;nico ou por meio da angioplastia, aplicando tamb&#233;m o SF-36, de forma auto-administr&#225;vel, indicou que o grupo angioplastia apresentou melhora substancial na qualidade de vida especialmente na vitalidade e nos componente f&#237;sico, quando comparado ao tratamento clinico. Esses resultados foram atribu&#237;dos &#224; maior presen&#231;a de sintomas de angina e tamb&#233;m de dispn&#233;ia, relatada pelos pacientes do grupo cl&#237;nico no final do estudo<sup>11</sup>.</p>
    <p>Um outro estudo destinado a comparar a qualidade de vida dos pacientes designados para os tratamentos cl&#237;nico ou cir&#250;rgico durante 10 anos de seguimento revelou que a melhora na qualidade de vida, a diminui&#231;&#227;o de sintomas anginosos, o aumento da atividade f&#237;sica e a redu&#231;&#227;o no uso de drogas antianginosas foi superior nos pacientes tratados por cirurgia somente nos primeiros anos de acompanhamento. No final do estudo, observou-se retorno dos sintomas de angina nos pacientes do grupo cir&#250;rgico, comprometendo, assim, a qualidade de vida desses pacientes<sup>26</sup>. </p>
    <p>Neste estudo, o SF-36 n&#227;o foi aplicado, e sim, um question&#225;rio gen&#233;rico. Um question&#225;rio auto-administr&#225;vel n&#227;o-especificado, avaliando atividade f&#237;sica e bem-estar geral, foi aplicado em pacientes submetidos a angioplastia e a tratamento medicamentoso. Neste estudo os pacientes tratados pela angioplastia apresentaram melhora significante das performances f&#237;sicas e mentais. Essa melhora foi relacionada aos pacientes que tiveram melhor desempenho nos testes de esfor&#231;o<sup>27</sup>. H&#225; de considerar que os pacientes deste estudo eram portadores de doen&#231;a coronariana uniarterial, angina est&#225;vel e fun&#231;&#227;o ventricular preservada, o que confere um excelente progn&#243;stico cl&#237;nico em longo prazo. Usando o Notthinghan Health Profile<sup>28</sup>, um instrumento de avalia&#231;&#227;o auto-administr&#225;vel, o <italic>Coronary Angioplasty versus Bypass Revascularization</italic> (CABRI) trial n&#227;o observou diferen&#231;a na qualidade de vida entre as duas formas terap&#234;uticas; contudo, ap&#243;s um ano de seguimento houve melhora na percep&#231;&#227;o da vitalidade entre os dois grupos de pacientes estudados<sup>29</sup>. </p>
    <p><italic>Considera&#231;&#245;es finais - </italic>Os estudos citados foram realizados em m&#250;ltiplos centros, em alguns, e em v&#225;rios paises, em outros. Considerando as diferen&#231;as socioculturais de cada centro de pesquisa, das diferentes amostras de pacientes estudadas, e tamb&#233;m dos diferentes instrumentos de qualidade de vida aplicados, h&#225; de ponderar a exist&#234;ncia de algum grau de vi&#233;s nos resultados obtidos nesses estudos. Por usa vez, a homogeneiza&#231;&#227;o da nossa amostra, considerada de pacientes est&#225;veis, apropriada simultaneamente, para qualquer tipo de tratamento ou interven&#231;&#227;o, teve implica&#231;&#245;es positivas no resultado final do estudo. Al&#233;m disso, o acompanhamento desses enfermos, realizado pela mesma equipe m&#233;dica que iniciou o tratamento, assim como as entrevistas de qualidade de vida feita pelo mesmo pesquisador contribu&#237;ram para melhor fidelidade dos resultados. Dessa forma, a melhora cl&#237;nica e tamb&#233;m na qualidade de vida, observada por todos os pacientes, deve ser considerada em um contexto de continuo acompanhamento e cuidados multiprofissionais, inclusive de programas de reabilita&#231;&#227;o espec&#237;fica. </p>
    <p>A significativa superioridade na qualidade de vida, em seus dois grandes componentes, e tamb&#233;m, em v&#225;rios dom&#237;nios, observada nos pacientes submetidos a cirurgia em rela&#231;&#227;o aos demais grupos terap&#234;uticos deve ser refletida, considerando-se toda a variabilidade cl&#237;nica, as co-morbidades, os aspectos f&#237;sicos e emocionais, as expectativas antes da interven&#231;&#227;o, e tamb&#233;m pela indica&#231;&#227;o terap&#234;utica randomizada admitida pelo paciente, como efetiva e definitiva.</p>
    <p>
      <bold>Potencial Conflito de Interesses</bold>
    </p>
    <p>Declaro n&#227;o haver conflitos de interesses pertinentes.</p>
    <p>
      <fn id="end" fn-type="corresp">
        <label>
          <bold>Correspond&#234;ncia:</bold>
        </label>
        <p> Neuza Lopes </p>
        <p> Av. Dr. En&#233;as Carvalho de Aguiar 44 ab sala 114 </p>
        <p> 05403-000 &#150; S&#227;o Paulo, SP </p>
        <p> E-mail: </p>
        <p>
          <email xlink:href="mass@incor.usp.br">mass@incor.usp.br</email>
        </p>
      </fn>
    </p>
    <p> Artigo recebido em 15/09/06; revisado recebido em 15/09/06; aceito em 26/01/07.</p>
  </body>
  <back>
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  <sub-article article-type="translation" id="TRen" xml:lang="en">
    <front-stub>
      <article-categories>
        <subj-group subj-group-type="heading">
          <subject>Original Articles</subject>
        </subj-group>
      </article-categories>
      <title-group>
        <article-title xml:lang="en">Quality of life after surgical myocardial revascularization, angioplasty or medical treatment</article-title>
      </title-group>
      <abstract xml:lang="en">
        <p>BACKGROUND: Although the clinical benefits of coronary interventions seem to be confirmed, their effects on quality of life (QoL) are still scarcely studied. OBJECTIVE: To assess the QoL in multivessel coronary disease in patients randomly undergoing surgery, angioplasty or medical treatment. METHODS: The Short-Form Health Survey (SF-36) questionnaire was answered by 483 patients. Of these, 161 underwent surgical revascularization, 166 underwent angioplasty, and 153 were medically treated. RESULTS: At baseline, 86% of the patients referred angina, 34% referred infarction, and 32% were smokers. Medical Treatment: 12 patients (7.7%) had AMI, 24 (15.3%) underwent surgery, and 19 (12.1%) died. In addition, 5 (3.2%) had stroke, and 40 (25.6%) had angina. As regards the mental component, 64.1% and 30.8% had their condition improved and worsened, respectively. As regards the physical component, 70.5% and 27.6% had their condition improved and worsened, respectively. Surgery: 13 patients (8.1%) had AMI, 2 (1.2%) underwent surgery, and 12(7.4%) died. Also, 9 (5.6%) had stroke and 30 (18.6%) had angina. As regards the mental component, 72.7 % and 25.5% had their condition improved and worsened, respectively. As regards the physical component, 82.6% and 16.1% had their condition improved and worsened, respectively. Angioplasty: 18 patients (10.9%) had AMI, 51 (30.7%) underwent interventions, and 18 (19.9%) died. Additionally, six (3.6%) presented stroke and 35 (21%) reported angina. As regards the mental component, 66.9% and 26.5% had their condition improved and worsened, respectively. As regards the physical component, 77.1% and 20.5% had their condition improved and worsened, respectively. CONCLUSION: Improvement was observed in all domains and in the three therapeutic modalities. Comparatively, surgery had provided a better quality of life after a four-year follow-up.</p>
      </abstract>
      <kwd-group xml:lang="en">
        <kwd>Quality of life</kwd>
        <kwd>coronary artery disease</kwd>
        <kwd>angina pectoris</kwd>
        <kwd>angioplasty</kwd>
        <kwd>myocardial revascularization</kwd>
      </kwd-group>
    </front-stub>
    <body>
      <p>
        <bold>ORIGINAL ARTICLE</bold>
      </p>
      <p>
        <bold>Quality of life after surgical myocardial revascularization, angioplasty or medical treatment</bold>
      </p>
      <p>
        <bold>Myrthes Emy Takiuti; Whady Hueb; Shirley Borghetti Hiscock; C&#233;lia Regina Sim&#245;es da Rocha Nogueira; Priscyla Girardi; Fabio Fernandes; Desiderio Favarato; Neuza Lopes; Jorge Chiquie Borges; A&#233;cio Fl&#225;vio Teixeira de G&#243;is; Jos&#233; Antonio Franchini Ramires</bold>
      </p>
      <p>Instituto do Cora&#231;&#227;o do Hospital das Cl&#237;nicas - FMUSP - S&#227;o Paulo, SP - Brazil</p>
      <p>
        <xref ref-type="corresp" rid="end-body2">Mailing address</xref>
      </p>
      <p>
        <bold>SUMMARY</bold>
      </p>
      <p><bold>BACKGROUND: </bold>Although the clinical benefits of coronary interventions seem to be confirmed, their effects on quality of life (QoL) are still scarcely studied.</p>
      <p><bold>OBJECTIVE: </bold>To assess the QoL in multivessel coronary disease in patients randomly undergoing surgery, angioplasty or medical treatment.</p>
      <p><bold>METHODS: </bold>The Short-Form Health Survey (SF-36) questionnaire was answered by 483 patients. Of these, 161 underwent surgical revascularization, 166 underwent angioplasty, and 153 were medically treated.</p>
      <p><bold>RESULTS: </bold>At baseline, 86% of the patients referred angina, 34% referred infarction, and 32% were smokers. Medical Treatment: 12 patients (7.7%) had AMI, 24 (15.3%) underwent surgery, and 19 (12.1%) died. In addition, 5 (3.2%) had stroke, and 40 (25.6%) had angina. As regards the mental component, 64.1% and 30.8% had their condition improved and worsened, respectively. As regards the physical component, 70.5% and 27.6% had their condition improved and worsened, respectively. Surgery: 13 patients (8.1%) had AMI, 2 (1.2%) underwent surgery, and 12(7.4%) died. Also, 9 (5.6%) had stroke and 30 (18.6%) had angina. As regards the mental component, 72.7 % and 25.5% had their condition improved and worsened, respectively. As regards the physical component, 82.6% and 16.1% had their condition improved and worsened, respectively. Angioplasty: 18 patients (10.9%) had AMI, 51 (30.7%) underwent interventions, and 18 (19.9%) died. Additionally, six (3.6%) presented stroke and 35 (21%) reported angina. As regards the mental component, 66.9% and 26.5% had their condition improved and worsened, respectively. As regards the physical component, 77.1% and 20.5% had their condition improved and worsened, respectively.</p>
      <p><bold>CONCLUSION: </bold>Improvement was observed in all domains and in the three therapeutic modalities. Comparatively, surgery had provided a better quality of life after a four-year follow-up.</p>
      <p><bold>Key words: </bold>Quality of life, coronary artery disease, angina pectoris, angioplasty, myocardial revascularization.</p>
      <p>
        <bold>Introduction</bold>
      </p>
      <p>Recent studies on quality of life (QoL) have been conducted in patients with several morbid conditions, with the purpose of assessing the different therapeutic measures aimed at improving the patients&#146; medical conditions, as well as their quality of life<sup>1</sup>. Included in this condition, coronary artery disease (CAD), which is considered one of the major causes of morbidity and mortality in the adult population, has a scenario that will probably not change in the coming years<sup>2</sup>.</p>
      <p>A disease based on risk factors such as dyslipidemia, smoking, diabetes mellitus and hypertension, which are subject to changes, the CAD may undergo interventions throughout its progression, with a consequent reduction in the risk of a coronary event, and, therefore, improvement of the patients&#146; quality of life (QoL)<sup>3</sup>.</p>
      <p>On one hand, these interventions contribute to an increase in survival and, on the other hand, to the progression of possible comorbidities triggered by this disease<sup>4,5</sup>. Thus, these interventions will interfere with the emotional, physical and social status, and mainly with the quality of life as a whole. Also, the continuous use of medications such as acetylsalicylic acid, beta-blockers, statins, and angiotensin-converting-enzyme inhibitors is an example of an intervention able to interfere with the progression of possible cardiovascular comorbidities<sup>6-8</sup>. Thus, with the growth of the elderly population and increase in longevity, diseases of the circulatory system will continue to lead the progressive development of different forms of therapeutic and pharmacological interventions aimed at changing these statistics<sup>9,10</sup>.</p>
      <p>Randomized studies with the objective of comparing the effects of CAD treatment on the survival and incidence of cardiovascular events, as well as on the long-term quality of life, resulted in conflicting conclusions<sup>11-13</sup>. These differences were mainly due to the different moments when the studies were conducted and to the therapeutic resources available, as well as to the different tools used to assess the patients&#146; quality of life.</p>
      <p>With the purpose of comparing the three therapeutic modalities available for the control of CAD symptoms and their respective interference on the patients&#146; quality of life, the MASS II (The Medicine, Angioplasty or Surgery Study II) was developed to evaluate the outcomes of the major clinical events, of long-term survival, and of the quality of life of patients undergoing medical treatment, surgery or angioplasty<sup>14</sup>.</p>
      <p>
        <bold>Methods</bold>
      </p>
      <p>Details of the Mass II study design, study protocol, patient selection and inclusion criteria have been previously published<sup>14</sup>. Briefly, patients with symptomatic multivessel CAD documented with angiograms, and myocardial ischemia identified by symptoms or exercise test were considered eligible for inclusion. Angina pectoris was classified according to the Canadian Cardiovascular Society (CCS) (class II or III)<sup>15</sup>.</p>
      <p> This study has been conducted in the <italic>Instituto do Cora&#231;&#227;o</italic> (InCor) <italic>do Hospital das Cl&#237;nicas da Faculdade de Medicina da Universidade de S&#227;o Paulo</italic> (FMUSP), and also in the Medical Unit of Chronic Coronary Artery Disease and other units interlinked for tests and procedures, with approval by the <italic>Instituto do Cora&#231;&#227;o</italic>&#146;s Scientific Commission under no. 946/94/56, and by the <italic>Hospital das Cl&#237;nicas da Faculdade de Medicina da Universidade de S&#227;o Paulo</italic>&#146;s Ethics Committee under no. 264/94/11. </p>
      <p><italic>Patient selection - </italic>From May, 1995 to May, 2000, 20769 patients undergoing coronary angiography due to a clinical suspicion of CAD were registered in a database. Of these, 18693 patients were excluded because they did not meet the specific protocol criteria. Of the remaining 2076 who were eligible for the three usual treatment modalities, 1465 patients were not included for not accepting to participate in a randomized study. Thus, the present study sample is comprised by the remaining 611 patients. The patients would be included and randomized if surgeons, hemodynamicists and clinicians simultaneously agreed on the possibility of any of the treatment modalities. Thus, 203 patients were assigned to surgical myocardial revascularization, 205 to angioplasty, and 203 to medical treatment. Awritten informed consent was obtained from all patients after they received detailed information on the study and had their questions answered. </p>
      <p><italic>Instruments - </italic>We used the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), a generic questionnaire for quality of life assessment conceived by Ware and Sherbourne<sup>16</sup> with the Portuguese version validated by Ciconelli<sup>17</sup>. This questionnaire is a tool that may be administered to persons from 12 years of age, and its objective is to assess the physical and mental health in the clinical practice both individually and in the general population. </p>
      <p>The questionnaire comprises 36 questions addressing eight domains (or dimensions) in two major components: the physical component that includes physical functioning, bodily pain, general health, and role physical; and the mental component that encompasses mental health, role emotional, social functioning, and vitality, and is assessed through 35 questions. Also, there is one additional question comparing their current health with that of the previous year. The purpose of the questions was to turn subjective measures into objective data that could be analyzed in a specific, global and reproducible manner (<xref ref-type="table" rid="tab01-body2">Table 1</xref>).</p>
      <table-wrap id="tab01-body2">
        <graphic xlink:href="1678-4170-abc-88-05-0537-00007-gt01-en.jpg"/></table-wrap>
      <p>A specific score for each question was used to analyze the results. A low numeric score reflected a poor perception of health, loss of function, and presence of bodily pain, whereas a high numeric score reflected a favorable perception of health, preserved function, and absence of bodily pain.</p>
      <p>The SF-36 was constructed to be a self-administered instrument; however it can also be administered in the interview format, which was used in our study with the purpose of standardizing the management, since a variation in the educational attainment was detected among our patients. The interviews were administered at baseline and at six, 12, 24, 36, and 48 months of follow-up.</p>
      <p>All interviews were conducted interpersonally and by the same investigator. However, in a previous study, when the SF-36 was administered via phone calls or interviews, or was self-administered, no differences were observed between the results obtained<sup>18</sup>.</p>
      <p>The demographic profile investigation questionnaire included questions on educational attainment, marital status, professional life, and relationship with work. We also sought to evaluate the occurrence of changes in the work environment related to the disease; of the economic situation in the professional prospects; and also of the influence of these changes from the patient&#146;s point of view. </p>
      <p><italic>Statistical analysis -</italic> The variables measured at more than one time point (baseline, 6, 12, 24, 36, 48 months) are shown in graphs containing means and standard error. The means were evaluated using analysis of variance for repetitive measures, where the following basic hypotheses were tested: </p>
      <p>Ho1: The mean profiles are parallel, that is, the groups have the same behavior; </p>
      <p>Ho2: The mean profiles are coincident, that is, there is no group effect; </p>
      <p>Ho3: There is no time effect, that is, the profiles are parallel to the abscissa axis. </p>
      <p>The generalized linear model was used to evaluate the scores at the 48-month time point. P values &lt; 0.005 were considered statistically significant. </p>
      <p>
        <bold>Results</bold>
      </p>
      <p>Of the 611 randomized patients comprising this study sample for long-term clinical follow-up, 483 were followed up for quality of life assessments and demographic profile questionnaire. These patients comprised the following therapeutic groups: surgical myocardial revascularization (SMR), 161 patients (33.3%); percutaneous coronary angioplasty (PCA), 166 patients (34.3%); and medical treatment (MT), 153 patients (32.4%), periodically followed up. The remaining 128 patients were excluded for finding it difficult to understand the questionnaire, for refusing to participate in this study, or for dying during follow-up, among other reasons. The vital status of all patients was concluded in May, 2004. The minimum duration of the research was 4 years for all patients. The therapeutic groups had well-balanced clinical and demographic characteristics related to significant prognostic factors of the disease. Thus, the patients in the three therapeutic modalities were similar as regards medical conditions, angiographic conditions, medication use, laboratory tests, and others. At baseline, 86% of the patients followed-up presented with class II or III (CCS) anginal symptoms, 34% reported previous myocardial infarction, and 32% were smokers, as shown in <xref ref-type="table" rid="tab02-body2">Table 2</xref>. All patients were using specific medications for their heart conditions and other comorbidities.</p>
      <table-wrap id="tab02-body2">
        <graphic xlink:href="1678-4170-abc-88-05-0537-00007-gt02-en.jpg"/></table-wrap>
      <p><italic>Medical treatment - </italic>After the four-year follow-up, of the 153 patients assigned for medical treatment, 12 (7.7%) had acute myocardial infarction, 24 (15.3%) underwent surgical myocardial revascularization, and 19 (12.1%) died. Also, five patients (3.1%) had a stroke and 40 (25.6%) reported symptoms of angina pectoris. Regarding quality of life, we observed significant changes both in the physical and in the mental components. Thus, as for the physical functioning domain, 104 patients (68%) improved, 13 patients (8.5%) remained unchanged, whereas 36 (23.5%) worsened. As for the role physical domain, 74 (48.5%) patients improved, 54 (35%) remained unchanged, and 25 (16.5%) worsened. In relation to bodily pain, 68 patients (44.5%) reported improvement, 48 (35.5%) reported worsening, and 37 (24%) remained unchanged. In the assessment of the general health, 90 patients (59%) improved, 44 patients (28.5%) worsened, and 19 patients (12.5%) remained unchanged. </p>
      <p>Also, the vitality assessment showed improvement in 87 patients (557%), worsening in 20 patients (13%), and an unchanged condition in the remaining 46 patients (30%). The social functioning improved in 74 patients (49%), worsened in 40 patients (25.5%), and remained unchanged in 39 patients (25.5%). The role emotional domain improved in 63 patients (41%), worsened in 33 patients (21.5), and remained unchanged in 57 patients (37.5%). Finally, as regards mental health, improvement was observed in 101 patients (66%), worsening in 42 patients (27.5%), and unchanged condition in 10 patients (6.5%).</p>
      <p><italic>Surgical treatment - </italic>During the follow-up period, of the 161 patients referred for surgical treatment, 13 (8.1%) had myocardial infarction, five (3.1%) underwent myocardial revascularization, and 12 (7.4%) died. Also, nine (5.6%) patients had a stroke, and 30 (18.6%) reported anginal symptoms. Changes in quality of life regarding the physical and mental components were also observed. Regarding the physical functioning domain, 130 patients (83.5%) showed improvement, eight patients (5%) remained unchanged, whereas 18 (11.5%) worsened. Regarding the role physical domain, 102 patients (65.5%) showed improvement, 38 (24.5%) remained unchanged, and 16 (10%) worsened. In relation to bodily pain, 87 patients (56%) reported improvement, 41 (26%) reported worsening, and 28 (18%) remained unchanged. In the assessment of general health, 116 patients (74.5%) showed improvement, 31 patients (20%) reported worsening and nine patients (5.5%) remained unchanged. Also, the assessment of vitality revealed improvement in 109 patients (70%), worsening in 36 patients (23%), and an unchanged condition in the remaining 11 patients (7%). Social functioning improved in 94 patients (60%), worsened in 31patients (20%), and remained unchanged in 31 patients (20%). The changes in the emotional role domain revealed improvement in 82 patients (52.5%), worsening in 25 patients (16%), and an unchanged condition in 49 patients (31.5%). Finally, in relation to mental health, improvement was observed in 105 patients (67.5%), worsening in 40 patients (25.5%), and no change in the 11 remaining patients (7%).</p>
      <p><italic>Angioplasty - </italic>During the four-year follow-up of the 166 patients undergoing angioplasty, 18 (10.9%) had acute myocardial infarction, 15 (9.0%) underwent surgical myocardial revascularization, 36 (21.7%) underwent repeat angioplasty, and 18 (10.9%) died. Also, six (3.6%) had stroke, and 35 (21%) referred symptoms of angina pectoris. Changes in quality of life regarding the two components analyzed &#150; the physical and the mental components, were also observed. Thus, in the physical functioning domain, 119 patients (73.5%) showed improvementand 13 patients (8%) remained unchanged, whereas 30 (18%) worsened. In the role physical domain, 92 patients (57%) showed improvement, 49 (30%) remained unchanged, and 21 (13%) worsened. As regards bodily pain, 79 patients (48.5%) reported improvement, 41 (25.5%) reported worsening, and 42 (26%) remained unchanged. In the general health assessment, 102 patients (63%) showed improvement, 42 patients (26%) reported worsening, and 18 patients (11%) remained unchanged.</p>
      <p>Also, the assessment of vitality showed improvement in 94 patients (58%), worsening in 45 (28%), and no change in the 23 (14%) remaining patients. Social functioning improved in 90 patients (55.5%), worsened in 32 patients (19.5%), and remained unchanged in 40 patients (25%). The changes in the role emotional domain showed improvement in 76 patients (47%), worsening in 19 patients (11.5%), and no change in 67 patients (41.5%). Finally, in relation to mental health, improvement was observed in 108 patients (67%), worsening in 40 patients (24.5%), and no change in the 14 remaining patients (8.5%). When the major clinical events were analyzed during the 4-year follow-up, a significant increase in the need for repeat interventions in patients undergoing angioplasty and need for angioplasty in the patients of the medical group, as well as a significant number of patients with anginal symptoms in all treatment groups were observed (<xref ref-type="table" rid="tab03-body2">Table 3</xref>).</p>
      <table-wrap id="tab03-body2">
        <graphic xlink:href="1678-4170-abc-88-05-0537-00007-gt03-en.jpg"/></table-wrap>
      <p>The analysis of the changes in all domains as observed at baseline and end of the follow-up comparing the three treatment modalities are shown in <xref ref-type="fig" rid="en_a07fig01-body2">Figure 1</xref>. Also, the comparison between medical treatment and both intervention treatments (surgery and angioplasty) showed a significant improvement in the role emotional, physical functioning, mental health, and general health domains (<xref ref-type="fig" rid="fig02-body2">Figure 2</xref>). When the results of the two major components (the physical and the mental components) - each with their four domains- were analyzed within these treatment groups, we found a significant improvement of these components with the intervention treatments. Comparison between the medical and the surgical treatment showed marked improvement of the eight domains in the patients undergoing surgery (<xref ref-type="fig" rid="fig03-body2">Figure 3</xref>). Improvement of the two major components was also observed in the surgical patients. Also, when the surgical treatment was compared with angioplasty, we observed a significant advantage of the surgical treatment in all but the emotional domain (<xref ref-type="fig" rid="fig04-body2">Figure 4</xref>). The same occurred in relation to the physical and mental components when these two treatments were compared. Finally, the comparison between medical treatment and angioplasty showed a significant improvement in the patients undergoing angioplasty in all but the bodily pain domain (<xref ref-type="fig" rid="fig05-body2">Figure 5</xref>). Significant improvement was also observed in the two major components (physical and mental) among the patients undergoing angioplasty in comparison with those undergoing medical treatment. The multivariate analysis of comorbidities as well as of the demographic data corrected for variables such as age, educational attainment, gender, smoking, diabetes, hypertension, infarction and angina status showed that, except for the mental health domain, a significant improvement was observed at the end of the three treatment modalities used.</p>
      <p content-type="asset">
        <fig id="en_a07fig01-body2">
          <graphic xlink:href="1678-4170-abc-88-05-0537-00007-gf01-en.jpg"/></fig>
      </p>
      <fig id="fig02-body2">
        <graphic xlink:href="1678-4170-abc-88-05-0537-00007-gf02-en.jpg"/></fig>
      <fig id="fig03-body2">
        <graphic xlink:href="1678-4170-abc-88-05-0537-00007-gf03-en.jpg"/></fig>
      <fig id="fig04-body2">
        <graphic xlink:href="1678-4170-abc-88-05-0537-00007-gf04-en.jpg"/></fig>
      <fig id="fig05-body2">
        <graphic xlink:href="1678-4170-abc-88-05-0537-00007-gf05-en.jpg"/></fig>
      <p>
        <bold>Discussion</bold>
      </p>
      <p>Physical or mental health assessment instruments are used to measure possible changes in quality of life resulting from certain medical interventions in controlled studies and also in population-based studies<sup>19</sup>. We currently observe the increasing frequency of clinical trials designed to specifically evaluate the safety and effectiveness of different procedures or techniques<sup>20</sup>, or pharmacological tests incorporating quality of life instruments<sup>21</sup>. The models used in these measurements have to be adequate to each type of population, treatment, or intervention, since the concept of quality of life may be specifically applied to measure the multiple aspects of physical or mental health. Most of the clinical trials using drugs or intervention treatments use self-administered questionnaires available for specific purposes<sup>22</sup>, and others for a great variety of diseases, mainly the chronic ones<sup>23-25</sup>.</p>
      <p>By administering the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), we observed improvement of all components, both physical and mental, at the end of the present study. This improvement, however, was more significant among patients undergoing surgery. The analysis of the different domains of the physical or mental components at baseline showed that the patients assigned for surgical treatment had a worse evaluation for these items in relation to the patients assigned for the other types of treatment. On the other hand, the surgical group was the one with the best quality of life at the end of the study. This result directly corroborates the better results of surgery in the progression of anginal symptoms, in the incidence of reinfarction, and in the need for additional interventions. On the other hand, although patients undergoing angioplasty required a significantly greater number of additional interventions in relation to the other types of treatment, they presented improvement in their quality of life at the end of the study when compared to patients of the medical group. Finally, patients who underwent medical treatment only also experienced improvement in their quality of life at the end of the study. It is important to point out that the continued periodic patient follow-up, the intense administration of drugs, and the strict control of risk factors in patients with potentially severe conditions may have contributed to these results. In this context, the maintenance of the same multiprofessional team had a key role in the favorable outcome of the patients in this study. Also, it is also worth pointing out that the instrument was administered using interviews, always by the same investigator, which provides a higher stability in the relationship between the patient and the health professional. Studies assessing the quality of life of patients undergoing intervention treatment (surgery vs. angioplasty) that used the same quality of life instrument (SF-36), although in a self-administered form, showed that by the end of three years of follow-up the angina status and return to work had a significant improvement in both forms of treatment. Anginal symptoms were less significant in the patients undergoing surgical treatment than in those undergoing angioplasty<sup>13</sup>. However, return to work was faster among the patients treated with angioplasty. In conclusion, similar improvement in the quality of life was observed in both treatment modalities. These studies that assessed patients undergoing medical treatment or angioplasty using the self-administered SF-36 showed that the angioplasty group had a significant improvement in the quality of life especially as regards vitality and the physical component, in comparison to the medical group. These results were attributed to the higher frequency of anginal symptoms and dyspnea reported by the patients of the medical group at the end of the study<sup>11</sup>. On the other hand, another study aiming at comparing the quality of life of patients assigned to medical or surgical treatment during a 10-year follow-up showed that the improvement in quality of life, decrease in anginal symptoms, increase in physical activity, and reduction in the use of anti-angina drugs were higher among the patients treated with surgery only in the first few years of follow-up. At the end of the study, patients in the surgical group had a recurrence of the anginal symptoms, which affected their quality of life<sup>26</sup>. In this study, not the SF-36, but a generic questionnaire was administered. A non-specified self-administered questionnaire assessing physical activity and general well being was administered in patients undergoing angioplasty and medical treatment. In this study, the patients treated with angioplasty had a significant improvement ofin their physical and mental performances. This improvement was related to the patients who had a better performance in the exercise tests<sup>27</sup>. We have to consider that the patients in this study had single-vessel coronary disease, stable angina, and preserved ventricular function, which provide an excellent clinical prognosis in the long term. Using the Nottingham Health Profile<sup>28</sup>, a self-administered assessment instrument, the Coronary Angioplasty versus Bypass Revascularization Trial (CABRI) did not show differences in quality of life between the two treatment modalities; however, after one year of follow-up, improvement in the vitality perception was observed between the two groups of patients studied<sup>29</sup>.</p>
      <p><italic>Final considerations - </italic>Some of the studies previously mentioned were conducted in multiple centers whereas others, in several countries. Given the social and cultural differences of each research center, the different patient samples studied, and also the different quality of life instruments used, some degree of bias in the results obtained in these studies has to be considered. On the other hand, the homogeneity of our sample, deemed as comprised of stable patients, and simultaneously appropriate for any type of treatment or intervention, had positive implications in the final result of the study. Also, the follow-up of these patients performed by the same medical team that started the treatment, as well as the quality of life interviews conducted by the same researcher, contributed to a better reliability of the results. Thus, the clinical and quality of life improvement experienced by all patients should be considered within a context of continuous follow-up and multiprofessional care, including specific rehabilitation programs. The significantly higher quality of life in its two major components and also in various domains observed among the patients undergoing surgery in relation to those of the other treatment groups should be analyzed considering the whole clinical variability, comorbidities, physical and emotional aspects, expectations prior to the intervention, as well as the randomized treatment indication deemed by the patients as effective and definitive. </p>
      <p>
        <bold>Potential Conflict of Interest</bold>
      </p>
      <p>No potential conflict of interest relevant to this article was reported.</p>
      <p>
        <bold>References</bold>
      </p>
      <p>
        <fn id="end-body2" fn-type="corresp">
          <label>
            <bold>Mailing address:</bold>
          </label>
          <p> Neuza Lopes</p>
          <p> Av. Dr. En&#233;as Carvalho de Aguiar 44 ab sala 114 </p>
          <p> 05403-000 &#150; S&#227;o Paulo, SP - Brazil</p>
          <p> E-mail: </p>
          <p>
            <email xlink:href="mass@incor.usp.br">mass@incor.usp.br</email>
          </p>
        </fn>
      </p>
      <p>Manuscript received September 15, 2006; revised manuscript received September 15, 2006; accepted January 26, 2007.</p>
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