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Combination Clopidogrel Plus Aspirin More Effective Than Aspirin Alone for Preventing Cerebral Microembolism: Presented at ESC

By Michael J. Worthington

MANNHEIM-HEIDELBERG, GERMANY -- May 18, 2004 -- Dual therapy with clopidogrel and aspirin is more effective than aspirin alone in reducing embolism in patients with carotid artery disease, researchers reported here on May 15^th at the 13^th European Stroke Conference.

Dr. Hugh Markus, Department of Clinical Neurosciences, St. George's Hospital Medical School, London, United Kingdom, reporting the findings on behalf of the CARESS (Clopidogrel and AspiRin on silent cerebral microEmboli in patients with non-operated Symptomatic carotid Stenosis) investigators.

The trial was designed to determine whether clopidogrel enhances the anti-embolic effect of aspirin in patients with recently symptomatic carotid stenosis who have developed an active embolism.

"There is a higher risk of early stroke after minor stroke or TIA [transient ischemic attack] then previously reported – 8% to 12% in 7 days," Dr. Markus said. "This early risk is particularly high in carotid stenosis, and aspirin fails to prevent many events."

The researchers enrolled 107 patients with 50% or more carotid stenosis, ipsilateral stroke or TIA within the last 3 months, and silent cerebral microemboli (MES) present on baseline Doppler recording. Fifty-one patients were randomized to treatment with clopidogrel or and 56 to placebo. Patients in the combination therapy arm were given clopidogrel 300 mg on day 1, which was reduced to 75 mg on days 2-7. All patients were treated with aspirin 75 mg from days 2-7.

The researchers recorded MES counts at baseline, on day 1 and day 7. The primary end point was occurrence of 1 or more MES versus none on day 7, and secondary end points were occurrence of 1 or more MES versus none at 24 hours and rate of embolism at 24 hours and at day 7.

On day 7, significantly fewer patients were MES positive in the combination therapy arm than in the aspirin alone arm (45% vs. 72.5%; relative risk reduction [RRR] 37.7%; P =.01). The rate of embolism in patients taking combination therapy was significantly lower than in patients taking aspirin alone, both at 24 hours (22.1% vs. 59.3%, respectively; P <.001) and at day 7 (14.4% vs. 37.1%; P =.001).

There were twice as many recurrent TIA or ischemic stroke events in patients on aspirin than in patients on combination therapy (12 vs. 5 events, respectively). The MES rate per hour was significantly higher in patients with recurrent stroke or TIA than in those without, both at baseline (28.3% vs. 11.1%, P =.0017) and at 24 hours (20.3% vs. 8.9%; P =.0026).

Major and life-threatening bleeding events were absent in both arms. Minor bleeding events occurred in 2 patients in the combination arm and 1 patient in the aspirin alone arm.

"Combination therapy resulted in rapid efficacy, which may be relevant in patients who are acute," Dr. Markum said.


[Presentation title: "The CARESS Trial."]

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