NEW YORK (Reuters Health) – Prasugrel helps stop thrombotic events in patients who undergo percutaneous coronary intervention (PCI), but associated “nuisance” bleeding may prompt discontinuation of such therapy, French researchers report in a September 8th on-line paper in the American Journal of Cardiology.
“Patient education,” Dr. Laurent Bonello told Reuters Health by email “is critical to further improve outcome. Minor bleeding should be taken into account more carefully in research trial and practice because it has a great impact on compliance to antiplatelet therapy and potentially on clinical outcome.”
To further investigate the extent of this impact, Dr. Bonello of Universite de la Mediterranee, Marseille and colleagues prospectively studied 396 patients who underwent successful stent implantation for acute coronary syndromes. Dual-antiplatelet therapy was recommended for all patients for a minimum duration of 12 months with aspirin 75 mg/day and prasugrel 10 mg/day.
Follow-up one month after PCI showed 54 patients (13.6%) had bleeding events. Most (96%) were classified as internal or nuisance. Three of internal bleeding patients (16.6%) stopped prasugrel as did 5 (14.7%) of those with nuisance bleeds. Most (79%) did so without medical consultation.
During the month of follow up, a total of 23 patients stopped prasugrel. This was significantly more likely in the internal or nuisance bleeding group (15.3% versus 4.0%).
During the follow-up period, major adverse cardiovascular events were few and there was no difference between groups.
“In light of our results,” the investigators conclude,”it appears critical to inform patients about the potential occurrence of these bleeds and the need to continue the drug despite this minor complication to prevent thrombotic recurrence.”
In the US, the packet insert for the agent (Effient, Daiichi Sankyo and Eli Lilly) carries a boxed warning both of the significant risks of bleeding and the increased risk of cardiovascular events should Effient be stopped. Minor bleeding is referred to in the main text.
Reference:
Rate of Nuisance Bleedings and Impact on Compliance to Prasugrel in Acute Coronary Syndromes
Am J Cardiol 2011.
