Optimized duration of clopidogrel therapy following treatment with the Endeavor zotarolimus-eluting stent in real-world clinical practice (OPTIMIZE) trial: rationale and design of a large-scale, randomized, multicenter study
Am Heart J
; 164: 810-819, 2012.
Artigo
em Inglês
| Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP
| ID: biblio-1059425
Biblioteca responsável:
BR79.1
Localização: BR79.1
ABSTRACT
Background Current recommendations for antithrombotic therapy after drug-eluting stent (DES) implantation includeprolonged dual antiplatelet therapy (DAPT) with aspirin and clopidogrel ≥12 months. However, the impact of such a regimen for all patients receiving any DES system remains unclear based on scientific evidence available to date. Also, several other shortcomings have been identified with prolonged DAPT, including bleeding complications, compliance, and cost. The second-generation Endeavor zotarolimus-eluting stent (E-ZES) has demonstrated efficacy and safety, despite short durationDAPT (3 months) in the majority of studies. Still, the safety and clinical impact of short-term DAPT with E-ZES in the real world is yet to be determined.Methods The OPTIMIZE trial is a large, prospective, multicenter, randomized (11) non-inferiority clinical evaluation of short-term (3 months) vs long-term (12-months) DAPT in patients undergoing E-ZES implantation in daily clinical practice.Overall, 3,120 patients were enrolled at 33 clinical sites in Brazil. The primary composite endpoint is death (any cause),myocardial infarction, cerebral vascular accident, and major bleeding at 12-month clinical follow-up post-index procedure.Conclusions The OPTIMIZE clinical trial will determine the clinical implications of DAPT duration with the secondgeneration E-ZES in real-world patients undergoing percutaneous coronary intervention.
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Coleções:
Bases de dados nacionais
/
Brasil
Base de dados:
Sec. Est. Saúde SP
/
SESSP-IDPCPROD
Assunto principal:
Stents Farmacológicos
/
Hiperplasia
Tipo de estudo:
Ensaio clínico controlado
/
Guia de prática clínica
Idioma:
Inglês
Revista:
Am Heart J
Ano de publicação:
2012
Tipo de documento:
Artigo
Instituição/País de afiliação:
Cardiologia Catanduva/BR
/
Center for Interventional Vascular Therapy/US
/
Emcor Emergências doCoração/BR
/
Hospital Bandeirantes/BR
/
Hospital Santa Marcelina/BR
/
Hospital dasClínicas da Universidade de São Paulo de Ribeirão Preto/BR
/
HospitalAgamenon Magalhães/BR
/
Instituto Dante Pazzanese de Cardiologia/BR
/
Institutodo Coração do Triângulo/BR
/
Real eBenemérita Sociedade Portuguesa de Beneficência/BR