FDA approves Medicines Co's antiplatelet drug
- Kengreal (cangrelor), manufactured by the Medicines Company in NJ, has been approved by the FDA for use during percutaneous coronary intervention (PCI).
- Kengreal is approved for use in adults only.
- According to the Centers for Disease Control and Prevention (CDC), PCI is performed on approximately 500,000 people each year in the U.S.
According to guidelines jointly published by the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions, antiplatelet therapy should be used before, during and after PCI in order to reduce the risk of ischemic events. However, in addition to reducing the risk of blood clots, clinicians must control for an increased risk of bleeds.
The most commonly used antiplatelet therapies during PCI are aspirin, Plavix (clopidogrel) and glycoprotein IIb/IIIa inhibitors. Kengreal was compared in clinical trials to Plavix in more than 10,000 patients. Although Kengreal signficiantly reduced the occurence of heart attack during the peri-PCI period, as well as the need for revascularization, it was associated with a higher risk of a serious bleed compared with Plavix. Overall one in 170 Kengreal patients had a serious bleed, compared with one in every 275 Plavix patients.
Despite an increased risk of a serious bleed with Kengreal, an additional antiplatelet option for use during a common procedure bodes well for the overall standard of care associated with cardiovascular surgical procedures. Caution, as always, is warranted.