Prasugrel (Effient) significantly reduces the risk of cardiovascular events in patients with acute coronary syndromes after PCI regardless of whether or not a glycoprotein (GP) IIb/IIIa inhibitor is used, according to an analysis of the TRITON–TIMI 38 trial in the Aug. 18 issue of the Journal of the American College of Cardiology.
On July 10, the FDA approved Daiichi Sankyo and Eli Lilly's Effient tablets for the reduction of thrombotic cardiovascular events, including stent thrombosis, in patients with acute coronary syndromes who are managed with PCI.
In TRITON–TIMI 38 (Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel–Thrombolysis in MI 38), prasugrel reduced cardiovascular events compared with clopidogrel, but with increased bleeding. Michelle O'Donoghue, MD, from the TIMI Study Group at Brigham and Women's Hospital in Boston, and colleagues assessed 7,414 subjects (54.5 percent), who received a GP IIb/IIIa inhibitor during their index hospitalization.
Researchers found that there was a consistent benefit of prasugrel over clopidogrel for reducing cardiovascular death, MI or stroke in patients who did or did not receive a GP IIb/IIIa inhibitor (hazard ratio: 0.78). Prasugrel significantly reduced MI, urgent revascularization and stent thrombosis irrespective of GP IIb/IIIa inhibitor use.
Although subjects treated with a GP IIb/IIIa inhibitor had greater rates of bleeding, they found that the risk of TIMI major or minor bleeding with prasugrel versus clopidogrel was not significantly different in patients who were or were not treated with GP IIb/IIIa inhibitor.
Based on their findings, O’Donoghue and colleagues said that despite the rapid onset of action of prasugrel, the use of a GP IIb/IIIa inhibitor does not appear to alter the relative risk of bleeding for patients treated with prasugrel versus clopidogrel when a thienopyridine loading dose is administered shortly before or at the time of PCI.
However, the authors noted that “randomized trials will be necessary to determine whether there is any incremental benefit for a GP IIb/IIIa inhibitor in the setting of prasugrel.”