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Trials  2000 

Is clopidogrel superior to aspirin in secondary prevention of vascular disease?

DOI: 10.1186/cvm-1-3-143

Keywords: aspirin, cerebral ischaemia, clopidogrel, myocardial infarction, peripheral artery disease

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A nice bottle of Graves arrived at our offices in early August 2000. The Dutch branch of Sanofi-Synthelabo sent this wine to collaborators of the Clopidogrel versus Aspirin in Patients at Risk of Ischaemic Events (CAPRIE) trial [1] to celebrate the regulation of reimbursement for clopidogrel in the Netherlands on 26 July. The official indication for this novel antiplatelet drug reads: 'secondary prevention in patients with atherosclerotic disease and proven aspirin sensitivity'. Sanofi-Synthelabo appealed against the limitation to patients intolerant to aspirin, but lost the lawsuit [2].What is the background of this legal quarrel? The cornerstone is clinical evidence from the CAPRIE trial, a ran-domised, blinded, international study [1]. Clopidogrel (75 mg daily) and aspirin (325 mg daily) were compared in the prevention of the composite outcome event 'vascular death, nonfatal stroke or nonfatal myocardial infarction'. Clopidogrel reduced the annual risk of such a vascular event from 5.83 to 5.32% in comparison with aspirin, corresponding to a relative risk reduction (RRR) of 8.7%. The 95% confidence interval just kept clear of the neutral value and ranged from 0.3 to 16.5%. The design of the study was based on the paradigm prevalent in the early 1990s: all clinical presentations of atherosclerotic disease should be regarded as different manifestations of a single disorder of the arterial vascular tree. The data of the CAPRIE trial do not necessarily support this paradigm, because the RRR values of the three diagnostic strata (each with over 6000 patients) differed considerably: -3.7% for myocardial infarction, +7.3% for ischaemic stroke, and 23.8% for peripheral arterial disease (P = 0.042). A similar difference between different categories of atherosclerotic disease had been observed by the AntiPlatelet Trialists' Collaboration [3]. The RRR values achieved by aspirin (compared with placebo) ranged from 18% for cerebral ischaemia to 35% for unstable angina.Clopido


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