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Presenter report 
Valgimigli, Marco (Italy)
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Inhibition of platelet aggregation following an intake of aspirin or clopidogrel varies greatly among patients, and previous studies have shown that poor response to oral antiplatelet agents increases the risk of thrombotic events, especially after coronary angioplasty. It was previously unknown if this reflected suboptimal platelet inhibition per se, which might benefit from alternative or more potent antiplatelet agents. |
Enrolled in the study were 263 patients (out of 1277 who were initially screened) who were poor responders to aspirin and/or clopidogrel, based on a point-of-care assay, who underwent elective coronary angioplasty at ten European sites for stable or low-risk unstable coronary artery disease. Patients were randomly assigned in a double blind manner to receive either high-dose bolus (HDB) tirofiban or placebo on top of standard aspirin and clopidogrel therapy.
The primary end point was the occurrence of periprocedural myocardial infarction, as defined by an increase in Troponin I or T greater than 3 times the upper limit of normal within 48 hours, which is in keeping with the universal definition of myocardial infarction consensus document. This was attained in 20.4 percent of patients treated with HDB tirofiban, compared to 35.1 percent of patient treated with placebo. This resulted in a significant reduction of major adverse cardiovascular events within 30 days in the HDB tirofiban group compared to the placebo group (21.2 percent versus 36.6 percent, respectively; p=0.0065). The incidence of bleeding was low and did not differ between the two groups.
These findings are significant in that we demonstrate a proof of concept for a new treatment strategy in a patient segment whose needs have so far remained unaddressed – managing for the increased risk of thrombotic events due to non-responsiveness of patients to standard oral antiplatelets such as aspirin or clopidogrel.