title: Three vs twelve months of dual antiplatelet therapy after zotarolimus-eluting stents: the OPTIMIZE randomized trial.
abstract: OBJECTIVE
  The current recommendation is for at least 12 months of dual antiplatelet therapy after implantation of a drug-eluting stent. However, the optimal duration of dual antiplatelet therapy with specific types of drug-eluting stents remains unknown.
  
  
  OBJECTIVE
  To assess the clinical noninferiority of 3 months (short-term) vs 12 months (long-term) of dual antiplatelet therapy in patients undergoing percutaneous coronary intervention (PCI) with zotarolimus-eluting stents.
  
  
  METHODS
  The OPTIMIZE trial was an open-label, active-controlled, 1:1 randomized noninferiority study including 3119 patients in 33 sites in Brazil between April 2010 and March 2012. Clinical follow-up was performed at 1, 3, 6, and 12 months. Eligible patients were those with stable coronary artery disease or history of low-risk acute coronary syndrome (ACS) undergoing PCI with zotarolimus-eluting stents.
  
  
  METHODS
  After PCI with zotarolimus-eluting stents, patients were prescribed aspirin (100-200 mg daily) and clopidogrel (75 mg daily) for 3 months (n = 1563) or 12 months (n = 1556), unless contraindicated because of occurrence of an end point.
  
  
  METHODS
  The primary end point was net adverse clinical and cerebral events (NACCE; a composite of all-cause death, myocardial infarction [MI], stroke, or major bleeding); the expected event rate at 1 year was 9%, with a noninferiority margin of 2.7%. Secondary end points were major adverse cardiac events (MACE; a composite of all-cause death, MI, emergent coronary artery bypass graft surgery, or target lesion revascularization) and Academic Research Consortium definite or probable stent thrombosis.
  
  
  RESULTS
  NACCE occurred in 93 patients receiving short-term and 90 patients receiving long-term therapy (6.0% vs 5.8%, respectively; risk difference, 0.17 [95% CI, -1.52 to 1.86]; P = .002 for noninferiority). Kaplan-Meier estimates demonstrated MACE rates at 1 year of 8.3% (128) in the short-term group and 7.4% (114) in the long-term group (HR, 1.12 [95% CI, 0.87-1.45]). Between 91 and 360 days, no statistically significant association was observed for NACCE (39 [2.6%] vs 38 [2.6%] for the short- and long-term groups, respectively; HR, 1.03 [95% CI, 0.66-1.60]), MACE (78 [5.3%] vs 64 [4.3%]; HR, 1.22 [95% CI, 0.88-1.70]), or stent thrombosis (4 [0.3%] vs 1 [0.1%]; HR, 3.97 [95% CI, 0.44-35.49]).
  
  
  CONCLUSIONS
  In patients with stable coronary artery disease or low-risk ACS treated with zotarolimus-eluting stents, 3 months of dual antiplatelet therapy was noninferior to 12 months for NACCE, without significantly increasing the risk of stent thrombosis.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT01113372.
authors.affiliation: Instituto Dante Pazzanese de Cardiologia, São Paulo, São Paulo, Brazil.
authors.forename: Fausto
authors.initials: F
authors.lastname: Feres
authors.affiliation: Instituto Dante Pazzanese de Cardiologia, São Paulo, São Paulo, Brazil.
authors.forename: Ricardo A
authors.initials: RA
authors.lastname: Costa
authors.affiliation: Instituto Dante Pazzanese de Cardiologia, São Paulo, São Paulo, Brazil.
authors.forename: Alexandre
authors.initials: A
authors.lastname: Abizaid
authors.affiliation: New York Presbyterian Medical Center, Columbia University Medical Center, and the Cardiovascular Research Foundation, New York, New York.
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
authors.affiliation: University of São Paulo, Ribeirão Preto, São Paulo, Brazil.
authors.forename: J Antônio
authors.initials: JA
authors.lastname: Marin-Neto
authors.affiliation: Instituto do Coração do Triângulo Mineiro, Uberlândia, Minas Gerais, Brazil.
authors.forename: Roberto V
authors.initials: RV
authors.lastname: Botelho
authors.affiliation: Saint Joseph's Medical Group, Atlanta, Georgia.
authors.forename: Spencer B
authors.initials: SB
authors.lastname: King
authors.affiliation: Medtronic CardioVascular, Santa Rosa, California.
authors.forename: Manuela
authors.initials: M
authors.lastname: Negoita
authors.affiliation: Medtronic CardioVascular, Santa Rosa, California.
authors.forename: Minglei
authors.initials: M
authors.lastname: Liu
authors.affiliation: Unicor de Linhares, Linhares, Espírito Santo, Brazil.
authors.forename: J Eduardo T
authors.initials: JE
authors.lastname: de Paula
authors.affiliation: Hospital Beneficência Portuguesa de São Paulo, São Paulo, São Paulo, Brazil.
authors.forename: José A
authors.initials: JA
authors.lastname: Mangione
authors.affiliation: Hospital Público Estadual de São Paulo, São Paulo, São Paulo, Brazil.
authors.forename: George X
authors.initials: GX
authors.lastname: Meireles
authors.affiliation: Hospital Bandeirantes, São Paulo, São Paulo, Brazil.
authors.forename: Hélio J
authors.initials: HJ
authors.lastname: Castello
authors.affiliation: Emcor Emergências do Coração, Piracicaba, São Paulo, Brazil.
authors.forename: Eduardo L
authors.initials: EL
authors.lastname: Nicolela
authors.affiliation: Hospital Santa Marcelina, São Paulo, Brazil.
authors.forename: Marco A
authors.initials: MA
authors.lastname: Perin
authors.affiliation: Hospital Padre Albino-FIPA, Catanduva, São Paulo, Brazil.
authors.forename: Fernando S
authors.initials: FS
authors.lastname: Devito
authors.affiliation: Santa Casa de Misericórdia de Marilia, Marilia, São Paulo, Brazil.
authors.forename: André
authors.initials: A
authors.lastname: Labrunie
authors.affiliation: Hospital Beneficência Portuguesa de São Paulo, São Paulo, São Paulo, Brazil.
authors.forename: Décio
authors.initials: D
authors.lastname: Salvadori
authors.affiliation: Hospital Agamenon Magalhães, Recife, Pernambuco, Brazil.
authors.forename: Marcos
authors.initials: M
authors.lastname: Gusmão
authors.affiliation: Instituto Dante Pazzanese de Cardiologia, São Paulo, São Paulo, Brazil.
authors.forename: Rodolfo
authors.initials: R
authors.lastname: Staico
authors.affiliation: Instituto Dante Pazzanese de Cardiologia, São Paulo, São Paulo, Brazil.
authors.forename: J Ribamar
authors.initials: JR
authors.lastname: Costa
authors.affiliation: Cardiovascular Research Center, São Paulo, São Paulo, Brazil.
authors.forename: Juliana P
authors.initials: JP
authors.lastname: de Castro
authors.affiliation: Cardiovascular Research Center, São Paulo, São Paulo, Brazil.
authors.forename: Andrea S
authors.initials: AS
authors.lastname: Abizaid
authors.affiliation: VA Boston Healthcare System, Brigham and Women's Hospital, and Harvard Medical School, Boston, Massachusetts.
authors.forename: Deepak L
authors.initials: DL
authors.lastname: Bhatt
mesh_terms: D054058:Acute Coronary Syndrome / Q000628:therapy*; D000368:Aged; D001241:Aspirin / Q000008:administration & dosage* / Q000009:adverse effects; D000077144:Clopidogrel; D003324:Coronary Artery Disease / Q000628:therapy*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D054855:Drug-Eluting Stents; D005260:Female; D006470:Hemorrhage; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D012306:Risk; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives; D020521:Stroke; D013927:Thrombosis; D013988:Ticlopidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*
chemical_list: D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; C489443:zotarolimus; D013988:Ticlopidine; D001241:Aspirin; D020123:Sirolimus