Accumetrics Obtains CE Mark for Therapeutic Window Claim on the VerifyNow P2Y12 Test
April 16, 2013 — Accumetrics Inc. announced an expansion in the intended use for the CE marked VerifyNow P2Y12 Test. Physicians can now use the test results to assess whether a patient may be at greater risk for both bleeding or ischemic events, as an aid to manage therapeutic treatment decisions and accurately assess the antiplatelet effect from P2Y12 inhibitors (such as clopidogrel, prasugrel and ticagrelor).
The expanded claim was developed based on the ADAPT-DES registry (8500 patients using the VerifyNow system), which validated the existence of a therapeutic window. The data demonstrated that patients with a P2Y12 Reaction Units (PRU) result of ≥208 were at a significantly increased risk of cardiovascular events and patients with a PRU of <95 were receiving virtually no additional protection from cardiovascular events, but at a significantly increased risk of bleeding.
“Balancing efficacy and safety is one of the most critical choices we need to make when selecting a P2Y12 inhibitor for long-term use in our patients,” said Gilles Montalescot, M.D., Ph.D., professor of cardiology for the Institut de Cardiologie at Hospital la Pitié-Salpêtrière in Paris, France. “In the ARCTIC study, we saw signs that a platelet reactivity guided strategy may result in less bleeding. This association was found in ADAPT-DES and suggests that we can use the information provided by the test to assess the bleeding risk of patients on treatment."
Previous studies have demonstrated the association between PRU and increased risk for recurrent ischemic and bleeding events. However, most of those studies were too small to warrant a label change for the VerifyNow P2Y12 Test. With the large number of patients, and real-world patient population represented in ADAPT-DES, there was significant evidence to proceed with a CE marked claim.
“Most prior analyses have focused upon platelet hyporesponsiveness as an established correlate of adverse ischemic events such as stent thrombosis,” stated Ajay J. Kirtane, M.D., SM, chief academic officer of the Center for Interventional Vascular Therapy at Columbia University Medical Center / NewYork-Presbyterian Hospital in New York City, who presented these data at ACC.13. “In this analysis from ADAPT-DES, the demonstration of increased bleeding events at the lowest levels of on-treatment platelet reactivity — independent of other baseline characteristics — suggests that there may be a price to pay for over-aggressive platelet inhibition, which can be measured through a point-of-care assay."
The addition of the therapeutic window claim marks the second major change to the intended use of the CE marked VerifyNow P2Y12 Test in the last two years. With a similar claim currently being reviewed by the U.S. Food and Drug Administration (FADA), Accumetrics is on track to have the first platelet reactivity test with a claim in the United States and the European Union to assess risk of both bleeding and ischemic events.
“The achievement of this new CE marked claim is a very positive step forward for the VerifyNow System and the entire field of platelet reactivity testing,” said Timothy Still, president and CEO of Accumetrics. “The expanded claims will provide greater clarity on how to interpret the VerifyNow P2Y12 and PRU Test results, which will enable an improved quality of care for the millions of patients on antiplatelet therapies.”
The VerifyNow System is currently used in over 1000 facilities in the United States and over 80 countries worldwide where antiplatelet medications are prescribed to reduce the occurrence of future thrombotic events such as heart attack and stroke. Platelet reactivity testing is already included in the following guidelines: European Society of Cardiology NSTE-ACS, ACC/AHA UA/NSTEMI, ACC/AHA/SCAI PCI and Society of Thoracic Surgeons Use of Antiplatelet Drug in Patients Having Cardiac and Non-Cardiac Surgery.
For more information: www.accumetrics.com