SAN FRANCISCO, CA – October 31, 2013 – According to a new study of heart attack patients treated with percutaneous coronary intervention (PCI), free access to platelet function testing had only a modest impact on anti-clotting drug selection and dosing. Findings of the TRANSLATE-POPS trial were presented today at the 25th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine.
While previous trials have examined platelet function testing-guided antiplatelet treatment strategies among patients undergoing PCI, little is known regarding how this testing impacts real world practice. The TRANSLATE-POPS trial evaluated whether routine availability of platelet function testing alters clinician selection and dosing of anti-clotting therapy, as well as patient outcomes after acute myocardial infarction treated with PCI. The primary end point was the rate of in-hospital therapeutic adjustments to anti-clotting therapy.
The prospective, cluster randomized trial randomly assigned sites not already routinely testing platelet function (<30 percent use) to either free and routine availability of platelet function testing (device arm) or the standard of care (usual care arm). In the device arm, sites were encouraged to test patients prior to discharge and at least 12 hours after PCI. Test results were available to the care team and all treatment decisions were left up to the care team. In the usual care arm, sites were not provided with routine platelet function testing, but the care team could elect to perform testing if deemed clinically necessary.
A total of 2,013 patients at 50 sites were enrolled in the device arm and 1,853 patients at 50 sites were enrolled in the usual care arm. Platelet function testing was performed in 66 percent of patients in the device arm and 1.4 percent of patients in the usual care arm. Compared to the usual care arm, device arm patients were more likely to have an in-hospital therapeutic adjustment of their antiplatelet regimen (15.9 percent in the device arm vs. 11.6 percent in the usual care arm). The device arm had a higher rate of switching antiplatelet agents (14.5 percent vs. 10.6 percent). The odds ratio for therapeutic adjustment, accounting for clustering effect within a site, was 1.54 for device vs. usual care.
However, after 30 days, patients in the device arm experienced a similar percentage of major adverse cardiac events compared to the usual care arm (4.5 percent vs. 5.1 percent, respectively). Both groups reported a similar rate of bleeding events (4.2 percent in the device arm vs. 4.3 percent in the usual care arm).
"TRANSLATE-POPS demonstrated that accessibility to platelet function testing had only a modest impact on ADP receptor inhibitor selection and dosing," said lead investigator Tracy Wang MD, MHS, MS of the Duke Clinical Research Institute.
"However, access to testing had no observed impact on early bleeding complications or major adverse cardiac events. An investigation of long-term outcomes is ongoing."
The TRANSLATE-POPS trial is funded by Lilly and Daiichi Sankyo. Dr. Wang reported research grants to the Duke Clinical Research Institute from Daiichi Sankyo, Eli Lilly, Gilead Sciences, and GlaxoSmithKline; and honoraria from AstraZeneca and the American College of Cardiology Foundation.
About CRF and TCT
The Cardiovascular Research Foundation (CRF) is an independent, academically focused nonprofit organization dedicated to improving the survival and quality of life for people with cardiovascular disease through research and education. Since its inception in 1991, CRF has played a major role in realizing dramatic improvements in the lives of countless numbers of patients by establishing the safe use of new technologies and therapies in interventional cardiovascular medicine. CRF is the sponsor of the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Celebrating its 25th anniversary this year, TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine. For more information, visit http://www.crf.org and http://www.tctconference.com.
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