Assessment of Prasugrel in Randomized Trials Confirmed in 'Real World'

Issue: March/April 2012

Prasugrel when given to patients who underwent PCI in clinical practice was associated with similar rates of major and minor bleeding as those reported in randomized trials, according to a study conducted in Italy.

Perspective from Gilles Montalescot, MD, PhD

The study included 298 consecutive patients who underwent stent implantation and received 60 mg prasugrel (Effient, Daiichi Sankyo/Eli Lilly). Researchers used TIMI criteria to determine rates of major, minor and minimal bleeding.

After a minimum follow-up of 6 months, major bleeding occurred in 2.7% of patients and minor bleeding in 4.7% of patients. Although the minimal bleeding rate of 15.1% was higher in this study vs. randomized trials, it did not seem to affect adherence to treatment, researchers reported. Independent predictors of bleeding events included low residual platelet reactivity (P=.001) and to a lesser extent female gender (P=.29). Researchers also reported that high residual platelet activity was uncommon during prasugrel therapy, occurring in 3.3% of patients.

For More Information:

Parodi G. Am J Cardiol. 2012;106:214-218.

Perspective

Gilles Montalescot, MD, PhD

This is an interesting paper and we will see more of these reports on the tolerance of the new P2Y12 antagonists in the real world. So far, the experience has been acquired only with prasugrel, and the data presented here reflect well what we and others have observed: This drug is well tolerated; there are no new side effects compared with clopidogrel; the drug is more potent than clopidogrel; and, in some patients, it may lead to minor or minimal bleeding events (bruising or epistaxis), as we had sometimes observed with clopidogrel. It is possibly more frequent but it rarely leads to drug discontinuation. Dr. Parodi and colleagues report also an interesting relationship between low residual platelet reactivity and bleeding, suggesting that the patients with a hyper-response to prasugrel are exposed to bleeding. Similar findings have been reported with the gain of function allele CYP2C19*17 when patients are on clopidogrel. It makes sense and suggests that platelet function monitoring and/or genotyping may help tailor antiplatelet therapy in coronary patients. This is one step further in the evaluation; results from the randomized ARCTIC study are expected later this year.

Gilles Montalescot, MD, PhD

Cardiology Today Intervention Editorial Board Member

Disclosures: Dr. Montalescot has received research grants and consulting or lecture fees from AstraZeneca, Daiichi Sankyo, Eli Lilly, Sanofi-Aventis and The Medicines Company.