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American Heart Association Late Breaking Clinical Trial Report: Tests Predict Which Patients Are Resistant to Anti-Clotting Therapy During Angioplasty, Stenting
Date:11/15/2009

Study highlights:

-- Three of six platelet reactivity tests predicted a risk of adverse outcomes related to blood clots in patients receiving two anti-clotting drugs following angioplasty (PCI) plus stenting.

-- Three other tests failed to predict excess risk.

-- It may soon be practical to test every PCI-plus-stent patient's response to anti-platelet therapy.

ORLANDO, Fla., Nov. 15 /PRNewswire-USNewswire/ -- Three platelet function tests all identified heart patients who will have blood cells that remain sticky, increasing heart attack risk, despite being pre-treated with two anti-clotting medications 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 (meaning the blood's likelihood to clot) despite anti-clotting medication.

Specifically, it examines which of the many tests available best predicts clot-related (thrombotic) complications, such as heart attack 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 blood clots arising within the stent (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 Plateletworks(TM) 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 Plateletworks(TM) 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 Dade® 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.

Statements and conclusions of study authors that are presented at American Heart Association scientific meetings are solely those of the study authors and do not necessarily reflect association policy or position. The association makes no representation or warranty as to their accuracy or reliability. The association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events. The association has strict policies to prevent these relationships from influencing the science content. Revenues from pharmaceutical and device corporations are available at www.americanheart.org/corporatefunding.

NR09 - 1159 (SS09/POPULAR / Breet and ten Berg)

SOURCE American Heart Association


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SOURCE American Heart Association
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