title: Safety of clopidogrel in older patients: a nonrandomized, parallel-group, controlled, two-centre study.
abstract: BACKGROUND
  The safety and efficacy of clopidogrel therapy in patients with stable coronary artery disease or acute coronary syndromes undergoing percutaneous coronary intervention (PCI) have been demonstrated.
  
  
  OBJECTIVE
  To evaluate the safety (primary outcome, defined as any bleeding complication or thrombocytopenia) and adverse outcomes (secondary outcomes, defined as death from cardiovascular causes, myocardial infarction or stroke) of clopidogrel therapy in patients aged ≥75 years with stable or unstable coronary artery disease undergoing PCI, and to compare these outcomes with those in younger controls.
  
  
  METHODS
  Patients with both stable coronary heart disease and acute coronary syndromes undergoing PCI were included in the study. Two groups were formed according to age at the time of admission. Patients aged ≥75 years (the study group, n = 149) formed one group; the other group included patients aged <75 years (the control group, n = 298). During an ad hoc PCI procedure, a 600 mg loading and 75 mg/day maintenance dose of clopidogrel in addition to aspirin (acetylsalicylic acid) therapy (300 mg/day) were administrated to both treatment groups. In-hospital outcomes were investigated during a mean ± SD follow-up period of 5.3 ± 3.9 days.
  
  
  RESULTS
  The first safety (primary) outcome of any bleeding event occurred in 16.1% of the patients in the study (older) group and 6.0% of the patients in the control (younger) group (odds ratio [OR] 2.987; 95% CI 1.565, 5.701; p = 0.001). The second safety outcome of TIMI (Thrombolysis in Myocardial Infarction) major bleeding occurred in 4.0% of the patients in the study group and 0.7% of the patients in the control group (OR 6.210; 95% CI 1.238, 31.151; p = 0.012). Other safety outcomes of TIMI minor/minimal bleeding and thrombocytopenia were not different between the two groups. The rate of the first adverse (secondary) outcome of the composite of death from cardiovascular causes, myocardial infarction or stroke was higher in older patients (12.1% vs 5.4%) [OR 2.422; 95% CI 1.197, 4.899; p = 0.012], primarily driven by stroke events (2.0% vs 0%; p = 0.014).
  
  
  CONCLUSIONS
  Any bleeding and TIMI major bleeding complications increase in patients aged ≥75 years treated with clopidogrel in addition to aspirin.
authors.affiliation: Department of Cardiology, Yuksek Ihtisas Heart-Education and Research Hospital, Ankara, Turkey. cayserkan@yahoo.com
authors.forename: Serkan
authors.initials: S
authors.lastname: Cay
authors.forename: Goksel
authors.initials: G
authors.lastname: Cagirci
authors.forename: Sinan
authors.initials: S
authors.lastname: Aydogdu
authors.forename: Yucel
authors.initials: Y
authors.lastname: Balbay
authors.forename: Nihat
authors.initials: N
authors.lastname: Sen
authors.forename: Orhan
authors.initials: O
authors.lastname: Maden
authors.forename: Ahmet D
authors.initials: AD
authors.lastname: Demir
authors.forename: Ali R
authors.initials: AR
authors.lastname: Erbay
mesh_terms: D054058:Acute Coronary Syndrome / Q000188:drug therapy* / Q000628:therapy; D000279:Administration, Cutaneous; D000367:Age Factors; D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D001241:Aspirin / Q000009:adverse effects / Q000627:therapeutic use; D000077144:Clopidogrel; D003324:Coronary Artery Disease / Q000188:drug therapy* / Q000628:therapy; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000139:chemically induced; D011446:Prospective Studies; D015607:Stents; D020521:Stroke / Q000139:chemically induced; D013921:Thrombocytopenia / Q000139:chemically induced; D013988:Ticlopidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin