FDA Approves Prasugrel for PCI Patients
The Food and Drug Administration approved the antiplatelet agent prasugrel to reduce the risk of clotting during percutaneous coronary intervention, with labeling that includes a boxed warning about the potential for significant and sometimes fatal bleeding. Prasugrel, a thienopyridine, was approved for reducing thrombotic cardiovascular events, including stent thrombosis, in the following patients with acute coronary syndrome who will be managed with percutaneous coronary intervention (PCI): those with unstable angina or non-ST elevation myocardial infarction (NSTEMI) and those with ST-elevation MI (STEMI), when managed with either primary or delayed PCI.
In the pivotal phase III trial of 13,608 patients with a threatened or actual myocardial infarction who were about to undergo angioplasty, prasugrel (Effient) was more effective than clopidogrel (Plavix) at reducing subsequent nonfatal myocardial infarction (9.1% vs. 7%). Patients with a history of stroke were more likely to have a repeat stroke on prasugrel, however. There was also a greater risk of significant bleeding events with prasugrel. Prasugrel's labeling includes a boxed warning about the bleeding, which advises against using the drug in patients with active pathologic bleeding, a history of transient ischemic attacks or stroke, or urgent need for surgery, including coronary artery bypass graft surgery.