Summary
Various diagnostic and prognostic performance measures have been used to describe
the clinical usefulness of platelet function testing in the evaluation and management
of patients taking P2Y12 inhibitors, which reduce the risk for thrombosis due to their action on the platelet
P2Y12 receptor. Platelet function tests are used to confirm the presence of an antiplatelet
effect of a P2Y12 inhibitor, and confirmation that the pharmacodynamic effect is associated with a
reduction in the rate of thrombosis. Despite this clear association, enthusiasm for
the clinical usefulness of platelet function testing has been tempered based on observed
sensitivity, specificity, and positive predictive value for the detection of future
thrombotic events. However, evaluating the prognostic utility of a test based on diagnostic
performance indicators is not appropriate because prognostic tests are not used to
diagnose which patients will have events; instead, they are used to assist in risk
stratification. Therefore, when evaluating the usefulness of platelet function testing,
diagnostic performance measures such as sensitivity, specificity, and predictive values
should focus on diagnostic performance in identifying a pharmacodynamic effect, and
prognostic performance should be evaluated using prognostic performance measures such
as hazard ratios and net reclassification improvement, which are comparable to other
well-established risk factors for cardiovascular events.
Keywords
Platelet function testing - antiplatelet agents - test statistics - platelet reactivity