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Safety of clopidogrel in older patients: a nonrandomized, parallel-group, controlled, two-centre study
Serkan Cay1, Goksel Cagirci, Sinan Aydogdu
1Department of Cardiology, Yuksek Ihtisas Heart-Education and Research Hospital, Ankara, Turkey. cayserkan@yahoo.com
Insights
Elderly patients (≥75 years) on clopidogrel and aspirin after PCI experienced significantly more bleeding complications, including major bleeding events. This increased risk warrants careful consideration in this patient population.
Area of Science:
- Cardiology
- Pharmacology
- Geriatrics
Background:
- Clopidogrel therapy is established for patients with coronary artery disease undergoing percutaneous coronary intervention (PCI).
- The safety and efficacy of clopidogrel in older adults require specific evaluation due to potential age-related differences in drug response and risk profiles.
Purpose of the Study:
- To assess the safety and adverse outcomes of clopidogrel plus aspirin in patients aged 75 years and older undergoing PCI.
- To compare these outcomes against a younger control group (<75 years).
Main Methods:
- A comparative study included 149 patients aged ≥75 years and 298 patients aged <75 years undergoing PCI.
- Both groups received a 600 mg loading dose and 75 mg/day maintenance dose of clopidogrel, plus 300 mg/day aspirin.
- In-hospital safety outcomes (bleeding, thrombocytopenia) and adverse outcomes (cardiovascular death, myocardial infarction, stroke) were monitored.
Main Results:
- Patients aged ≥75 years had a significantly higher incidence of any bleeding (16.1% vs 6.0%) and Thrombolysis in Myocardial Infarction (TIMI) major bleeding (4.0% vs 0.7%).
- The composite outcome of cardiovascular death, myocardial infarction, or stroke was also higher in the older group (12.1% vs 5.4%), driven by an increase in stroke events.
- No significant differences were observed in TIMI minor/minimal bleeding or thrombocytopenia between the groups.
Conclusions:
- Clopidogrel in addition to aspirin therapy is associated with increased rates of any bleeding and TIMI major bleeding in patients aged 75 years and older undergoing PCI.
- The findings highlight a heightened bleeding risk in elderly patients treated with this antiplatelet regimen post-PCI.
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.
Objectives:
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.
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