title: 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.
abstract: BACKGROUND
  Current recommendations for antithrombotic therapy after drug-eluting stent (DES) implantation include prolonged 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 duration DAPT (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 (1:1) 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 second generation E-ZES in real-world patients undergoing percutaneous coronary intervention.
authors.affiliation: Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.
authors.forename: Fausto
authors.initials: F
authors.lastname: Feres
authors.forename: Ricardo A
authors.initials: RA
authors.lastname: Costa
authors.forename: Deepak L
authors.initials: DL
authors.lastname: Bhatt
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
authors.forename: Roberto V
authors.initials: RV
authors.lastname: Botelho
authors.forename: Spencer B
authors.initials: SB
authors.lastname: King
authors.forename: J Eduardo T
authors.initials: JE
authors.lastname: de Paula
authors.forename: José A
authors.initials: JA
authors.lastname: Mangione
authors.forename: Décio
authors.initials: D
authors.lastname: Salvadori
authors.forename: Marcos O
authors.initials: MO
authors.lastname: Gusmão
authors.forename: Hélio
authors.initials: H
authors.lastname: Castello
authors.forename: Eduardo
authors.initials: E
authors.lastname: Nicolela
authors.forename: Marco A
authors.initials: MA
authors.lastname: Perin
authors.forename: Fernando S
authors.initials: FS
authors.lastname: Devito
authors.forename: J Antônio
authors.initials: JA
authors.lastname: Marin-Neto
authors.forename: Alexandre
authors.initials: A
authors.lastname: Abizaid
mesh_terms: D000328:Adult; D001241:Aspirin / Q000009:adverse effects / Q000627:therapeutic use*; D001938:Brazil; D000077144:Clopidogrel; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000150:complications / Q000401:mortality / Q000628:therapy*; D004359:Drug Therapy, Combination; D054855:Drug-Eluting Stents; D006801:Humans; D062645:Percutaneous Coronary Intervention; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D011184:Postoperative Period; D011446:Prospective Studies; D012107:Research Design; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013988:Ticlopidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; C489443:zotarolimus; D013988:Ticlopidine; D001241:Aspirin; D020123:Sirolimus