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Results of rapid gene trial reported at TCT 2011
Date:11/9/2011

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Existing genetic testing methods are time-consuming, require laboratory expertise and cannot be performed at the clinical bedside. These limitations preclude timely identification of the CYP2C19*2 allele in patients undergoing PCI.

In the RAPID GENE study, which was conducted by a team of investigators at the University of Ottawa Heart Institute, 200 patients undergoing PCI for ACS or stable angina were randomized to a strategy of rapid point-of-care genotyping with selective administration of 10 mg of prasugrel to CYP2C19*2 carriers or to standard therapy with 75 mg of clopidogrel daily.

The study utilized the first point-of-care genetic test in medicine, which overcame many of the previous obstacles that had prevented routine clinical genetic testing. The test featured: A saliva (buccal) swab performed by clinical nurses with no prior training in genetic laboratory techniques A one step insertion of the swab into testing machine Sixty minutes to identify whether individuals carried the at-risk genetic variant.

The primary endpoint was the proportion of CYP2C19*2 carriers with impaired anti-platelet therapy response (high on-treatment platelet reactivity) in the rapid genotyping arm compared to those in the standard therapy arm after seven days. Secondary endpoints included sensitivity and specificity of the point-of-care test compared to conventional genetic testing, other measures of platelet function among CYP2C19*2 carriers and the whole cohort by randomization, MACE, and bleeding risk measured by the TIMI scale.

Enrollment of the study was completed in July 2011. In total, 187 patients completed follow-up with 91 patients in the rapid genotyping group and 96 patients in the standard therapy group.

The primary endpoint showed that the proportion of CYP219*2 carriers with high on-treatment platelet reactivity (PRU> 234) was 0% in the rapid genotyping group compared with 30.4% in the standard the
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Contact: Judy Romero
jromero@crf.org
Cardiovascular Research Foundation
Source:Eurekalert

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