TRITON–TIMI 38 substudy shows prasugrel reduces overall mortality rate in ACS patients

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®/Effient® (prasugrel) prior to coronary artery bypass graft surgery (CABG) had a reduced overall mortality rate compared to patients treated with Plavix® (clopidogrel) (2.3 percent versus 8.7 percent respectively,>

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,>

"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.

Study Methodology

TRITON-TIMI 38 was a Phase III, randomized, double-blind, head-to-head clinical trial comparing the effects of prasugrel versus clopidogrel in patients with ACS who were managed with percutaneous coronary intervention (PCI), a procedure to open blockages in heart arteries, including the use of coronary stenting. The study enrolled 13,608 patients at 707 trial sites in 30 countries.

The primary endpoint of the study was the combined incidence of cardiovascular death, non-fatal heart attack or non-fatal stroke during at least 12 months following PCI. Patients were randomly assigned to one of two treatment groups and given a loading dose of either prasugrel 60 mg or the FDA-approved loading dose of clopidogrel 300 mg, followed by a daily maintenance dose of either prasugrel 10 mg or clopidogrel 75 mg. All patients also received a daily dose of aspirin (75 mg to 325 mg).

This retrospective analysis included newly collected data on 346 patients who underwent isolated CABG following withdrawal of study drug, either prasugrel>