Evolução clínica tardia dos stents farmacológicos: segurança e eficácia até cinco anos do registro DESIRE / Long-term clinical outcomes of drug eluting stents: safety and efficacy up to five years of the DESIRE registry

RESUMO

Fundamentos A expansão das indicações para o uso dos stents farmacológicos liberadores de sirolimus e de paclitaxel lesões de complexidade crescente e populações com perfil clínico muito diferente daquele dos estudos randomizados fundamentais. O registro DESIRE foi idealizado para monitorar a efetividade e a segurança institucional dos stents farmacológicos disponíveis pra uso clínico desde 2002, em nosso meio. Método e Resultados: Entre maio/2002 e março/2007, foram incluídos 2.043 pacientes (P) tratados com maior ou menor Cypher ou Taxus, no Hospital do Coração da Associação do Sanatório Sírio, em São Paulo - SP. A média das idades foi de 63,8 mais ou menos 11,3 anos, 76,6 por cento eram do sexo masculino e 28,49 por cento eram diabéticos. Um total de 2.415 lesõs foram tratadas, sendo implantados 2.983 stents 2.608 Cypher e 375 Taxus. as tromboses agudas/subagudas (menor ou igual 30 dias),...

ABSTRACT

Background: Indications for the implantation of sirolimusand paclitaxel-eluting stents are expanding and include complex lesions and subsets of patients with clinical and demographic characteristics very different from those of early pivotal randomized trials. The DESIRE Registry was planned to monitor the safety of both Cypher® and Taxus® stent available in Brazil since 2002. Methods and Results: From May 2002 through March 2007, 2043 patients treated with one or more than one stent (either Cypher® or Taxus®) at Hospital do Coração da Associação do Sanatório Sírio were included in this Registry. Mean age was 63.8 (11.3) years; 76.6% were male and 28.4% had diabetes. A total of 2,415 lesions were treated and 2,983 stents were implanted 2,608 Cypher® and 375 Taxus®. Acute and subacute (≤30 days); late thrombosis (31 days - 360 days) and very late thrombosis (>360 days) occurred in 0.34%, 0.73% and 0.34% of the patients, adding up to a 1.42% overall rate. Likewise, the major adverse cardiac event rate was low and added up to 8.6% (154 patients), including 45 (2.51%) cardiac deaths; 50 (2.8%) myocardial infarctions and 59 (3.3%) of additional revascularizations...