This approval is big news in the cardiology community. We have been waiting for this for some time.
Preasugrel is an anti-platelet drug (like Plavix) and is vital when used after a stent placement to prevent stent thrombosis (clotting within the stent).
We have been excited about its approval ever since the publication of the TRITON-TIMI 38 trial.
That trial showed a 19% reduction in composite cardiovascular death, MI, and stroke compared with clopidogrel (9.9% versus 12.1%, P<0.001).
The number of patients who had a subsequent nonfatal MI dropped to 7.0% with prasugrel compared with 9.1% with clopidogrel.
However, there are some safety concerns as well. In that trial, major bleeding events occurred in 2.4% of prasugrel patients compared with 1.8% of those in the clopidogrel arm.
Most of the bleeing was in patients over 75 years of age, those frail and very thin and those with a history of a stroke.
Therefore, while the drug is not for everyone, it will give use another tool to help lower the risk of major cardiac events after stenting.
Ted
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