Mortality Data Presented for Patients Treated with Efient(R)/Effient(R) (Prasugrel) Who Underwent Isolated Coronary Arte

New results from an observational substudy from TRITON-TIMI 38 presented today at the American Heart Association (AHA) Scientific Sessions annual meeting showed that patients treated with Efient(R)/Effient(R) (prasugrel) prior to coronary artery bypass graft surgery (CABG) had a reduced overall mortality rate compared to patients treated with Plavix(R) (clopidogrel) (2.3 percent versus 8.7 percent respectively, p=0.016). This retrospective analysis involved 346 patients with acute coronary syndrome (ACS) who had received either study drug and subsequently underwent isolated CABG at some point during the 15-month TRITON-TIMI 38 trial.
In addition to all-cause mortality, this same analysis found that the risk-adjusted rate of cardiovascular death at 30 days was also lower in patients treated with prasugrel compared with those receiving clopidogrel (0.6 percent versus 5.8 percent respectively, p=0.038). Prasugrel-treated patients experienced a statistically significantly higher volume of chest tube blood loss at 12 hours post-CABG compared to the clopidogrel-treated patients (655 +/- 580 milliliters with Effient versus 503 +/- 378 milliliters with clopidogrel.
"This analysis showed that prasugrel was associated with a significantly lower mortality rate compared with clopidogrel among these CABG patients but with a significantly higher risk of serious bleeding events," said Peter K. Smith, M.D., professor of surgery and division chief of Cardiovascular and Thoracic Surgery at Duke University Medical Center and lead investigator for the retrospective CABG analysis. "This analysis helps better define the risk of mortality for physicians who care for the ACS patients who may be targeted for PCI but end up undergoing CABG instead."
The prasugrel prescribing information includes a warning and precaution against starting prasugrel in patients likely to undergo urgent CABG surgery. The risk of bleeding is increased in patients receiving prasugrel who undergo CABG. If possible, prasugrel should be discontinued at least 7 days prior to CABG.