Abstract 3539: Low Inflammatory Activity Evidenced By hsCRP Predicts A Benefit From Clopidogrel Treatment In Patients With High Risk For Cardiovascular Events. - A Substudy From The CHARISMA Trial
Aims We investigated the impact of clopidogrel treatment on the inflammatory activity as evidenced by a change of hsCRP levels in a broad population of high risk for atherothrombotic events. Further, the prediction of hsCRP levels for a treatment benefit of clopidogrel was explored.
Methods This study included 8021 patients with overt atherosclerotic disease or multiple cardiovascular risk factors enrolled in the CHARISMA trial. Patients were randomized either to clopidogrel plus aspirin or placebo plus aspirin. HsCRP was measured at study entry and at study termination (median 28 months). The predefined primary endpoints were myocardial infarction, stroke and death from cardiovascular causes.
Results There was a stepwise increase in the event rate of the combined primary endpoint with increasing quartiles of hsCRP (4.0%, 6.1%, 7.4% and 8.7% in the highest quartile). In both treatment groups the changes of hsCRP levels over time were identical. In patients with low hsCRP levels (<3 mg/l) clopidogrel treatment was associated with a lower event rate as compared to placebo (4.0% vs. 6.0%, Log-rank p=0.005). In contrast no treatment effect could be observed in patients with high hsCRP levels (8.1% vs. 8.0%, ns).
Conclusions Surpisingly, the reduction of cardiovascular events by antiplatelet treatment with clopidogrel occurred in patients with low levels of hs-CRP