POPULAR: Tests predict which patients
are resistant to anti-clotting therapy during angioplasty plus stenting
Three platelet function tests all identified heart patients
who will have high platelet reactivity, increasing heart attack risk, despite
being pre-treated with aspirin and clopidogrel before coronary stenting, researchers
reported at the American Heart Association's Scientific Sessions 2009.
POPULAR (Do platelet function assays predict clinical
outcomes in clopidogrel pre-treated patients undergoing elective PCI) is the first
head-to-head comparison of tests for platelet reactivity despite anti-clotting
medication.
Specifically, it examines which of the many tests available
best predicts thrombotic complications, such as myocardial infarction and stroke,
in patients pre-treated with aspirin and clopidogrel who then undergo percutaneous
coronary intervention (PCI) with stent implantation, said Jurrien M. ten Berg,
M.D., Ph.D., an interventional cardiologist at St. Antonius Hospital, Nieuwegein,
the Netherlands, and senior investigator of the study.
"Only a minority of centers routinely uses platelet reactivity
testing to guide therapy, but it is used extensively as a research tool," he said.
"I think we are on the brink of making platelet reactivity a clinical tool."
Dual antiplatelet therapy with aspirin and clopidogrel
is used for its ability to reduce clot-related complications of PCI. But in some
studies a significant number (30-40 percent) of patients are resistant to the
treatment and are at risk of clot-related complications even after that treatment,
said ten Berg.
Researchers haven't conducted a large study comparing
the many tests that check platelet reactivity, said Nicoline J. Breet, M.D., presenter
of the study and a Ph.D. fellow and cardiologist-in-training at St. Antonius Hospital.
In POPULAR, researchers compared six different tests
of platelet reactivity in 1,069 consecutive patients undergoing angioplasty with
stent placement and included one-year follow-up. The primary endpoint was a composite
of all-cause death, heart attack, urgent revascularization, stroke or stent thrombosis,
ten Berg said.
Patients who had high platelet reactivity (HPR) on three
of the tests -- the Light Transmittance Aggregometry (LTA), the VerifyNow-P2Y12®
-cartridge and the PlateletworksTM assay - had a significantly greater
incidence of the combined primary endpoint (12.1 percent vs. 6 percent) at one
year compared to patients who did not, ten Berg said. Three other tests evaluated
didn't predict outcomes. Of the three predictive tests, the LTA is the most labor-intensive
and can't be performed at bedside, and PlateletworksTM must be done
within 10 minutes of drawing blood, ten Berg said. The third test, VerifyNow-P2Y12®
does not have those limitations, he said.
In conclusion, it is useful to test the response to antiplatelet
therapy in all patients undergoing elective angioplasty plus stent placement to
identify those patients at highest risk for clot-related complications," ten Berg
said.
These results have not yet been extended to demonstrate
that basing additional treatment(s) on the test results would improve patient
outcomes in those at higher risk.
Study sponsor: The study received no funding. Siemens
Healthcare Diagnostics provided the DadeR PFA Collagen/ADP Test Cartridge and
the novel INNOVANCE®
PFA P2Y* free-of-charge.
Co-authors are: Jochem W. van Werkum M.D., Ph.D.; Heleen
J. Bouman MSc; Johannes C. Kelder, M.D.; Henk J.T. Ruven, Ph.D.; Egbert T. Bal,
M.D.; Vera H. Deneer, PharmD, Ph.D.; Ankie M. Harmsze, PharmD; Jan A.S. van der
Heyden, M.D.; Benno J.W.M. Rensing, M.D., Ph.D.; Maarten J. Suttorp, M.D., Ph.D.;
Christian M. Hackeng, Ph.D.; Jurrien M. ten Berg, M.D., Ph.D.
Disclosures: None related to this study.
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