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| | | ![]() Aspirin Plus Clopidogrel After TIA or Minor Stroke Confers Significant Bleeding Risk in Aspirin-Naïve Patients: Presented at ESC By Judith Moser, MD STOCKHOLM, Sweden -- May 28, 2009 -- Following a minor stroke or transient ischaemic attack (TIA), a 30- to 90-day treatment course of aspirin plus clopidogrel results in a significant risk of life-threatening and major bleeding in aspirin-naïve patients, according to an analysis presented here at the 18th European Stroke Conference (ESC). Some evidence for aspirin plus clopidogrel was provided by the Fast Assessment of Stroke and Transient Ischaemic Attack to Prevent Early Recurrence (FASTER) study and the Early Use of Existing Preventive Strategies for Stroke (EXPRESS) trials as well as some cardiology trials. "The FASTER trial showed an increased risk of bleeding in the aspirin plus clopidogrel group compared with the treatment with aspirin alone," said Olivia C. Geraghty, MD, Stroke Prevention Research Unit, Department of Clinical Neurology, University of Oxford, Oxford, United Kingdom, who presented the study on May 26. "This was true on all levels of severity." The aim of the present study was to determine the short-term risk of bleeding in the EXPRESS clinic population (all referrals from 2002-2008) in relation to the antiplatelet regimen. "We validated our findings using data from the FASTER Pilot," Dr. Geraghty explained. Patients were stratified in 2 groups according to the antiplatelet regimen (aspirin alone, n = 386; aspirin plus clopidogrel, n = 247). The participants in the combination group had a higher prevalence of premorbid vascular risk factors including hypertension, hyperlipidaemia, and prior history of myocardial infarction. TIA and stroke were equally represented (54% and 46%, respectively). The vast majority of patients (93%) had a National Institutes of Health Stroke Scale score of 0 to 3. "As for the bleeding event rates at 90 days, we found a significantly higher risk in the group that received aspirin plus clopidogrel," said Dr. Geraghty. The rate was 3.2% combination group versus 1.0% in the aspirin-only group (P = .047). This finding pertained to all levels of severity and was mirrored in the FASTER Pilot, which showed rates of 3.0% versus 0%. The excess bleeds occurred only in aspirin-naïve patients. According to the pooled data from EXPRESS and FASTER, the crude 90-day risk of life-threatening or major bleeding on aspirin plus clopidogrel was 3.7% in aspirin-naïve patients compared with 0.5% in the patients who had received a prior aspirin treatment (P = .009). In some cases, the treatment with aspirin plus clopidogrel was continued to 90 days. "The pooled 90-day actuarial risk of life-threatening or major bleeding on this treatment was 4.8% in the aspirin-naïve group," Dr. Geraghty pointed out. In order to determine the balance of risk and benefit after acute TIA and minor stroke, more trials of short-term aspirin plus clopidogrel versus aspirin alone are required. "Care should be taken in all trials of combination antiplatelet treatment to monitor risk specifically in aspirin-naïve patients," Dr. Geraghty cautioned. Presentation title: High Risk of Bleeding on Aspirin Plus Clopidogrel in Aspirin-Naïve Patients in the Acute Phase After TIA or Minor Ischaemic Stroke
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