May 15, 2015 — Prasugrel (Effient) is more likely to be given to lower-risk heart disease patients undergoing percutaneous coronary intervention (PCI) compared to clopidogrel, according to a new study. Results of the PROMETHEUS study, which examined how the two drugs are used across academic medical centers in the United States, were presented as a late-breaking clinical trial at the Society for Cardiovascular Angiography and Interventions (SCAI) 2015 Scientific Sessions in San Diego.
As newer antiplatelet medications become available, little is known about the actual use of the drugs in clinical practice. Prasugrel was approved by the U.S. Food and Drug Administration (FDA) in 2009 to treat acute coronary syndrome (ACS) patients undergoing PCI. Compared to clopidogrel, studies showed prasugrel reduces the risk of thrombotic events but is associated with an increased risk of bleeding.
For the new study, researchers reviewed data in 19,914 heart disease patients undergoing PCI with stenting at eight U.S. academic medical centers between January 2010 and June 2013. For patients receiving either prasugrel or clopidogrel, researchers reviewed data on major adverse cardiac events (MACE; including death, heart attack, stroke or unplanned revascularization) and bleeding requiring hospitalization within 90 days of PCI.
“Data examining the use, safety and efficacy of these drugs in ‘real-world’patients not enrolled in randomized trials remains limited. Results from our study provide insight on both clinical decision-making and the risk/benefit profile surrounding prasugrel use at the time of PCI in ACS patients,” said Usman Baber, M.D., MS, assistant professor of cardiology at Mount Sinai Hospital in New York, and co-principal investigator.
Data showed 4,058 patients (20.4 percent) received prasugrel at the time of PCI. These patients tended to be younger, more often male, and had less renal dysfunction and anemia than patients (n=15,856) receiving clopidogrel. On the other hand, they also were more likely to present with ST-elevation myocardial infarction (STEMI; a more serious heart attack) and to receive longer stents.
After 90 days, patients receiving prasugrel had lower rates of adverse events (9.6 percent vs. 5.7 percent, p<0.001), translating to a large (42 percent) relative reduction favoring prasugrel. After adjusting for baseline differences, however, his reduction was attenuated to a more modest and non-significant 11 percent benefit. Analogously, adjusted bleeding rates were not significantly different between groups.
“Overall we found substantial differences in patient profiles receiving prasugrel as compared to clopidogrel. Risk factors for both ischemic and hemorrhagic complications were much lower in prasugrel-treated patients. Used in this manner, the benefit of prasugrel in lowering ischemic events was attenuated while harm in terms of bleeding risk was also minimized,” said Baber.
Baber reported no relevant disclosures.
For more information: www.scai.org