• STEMI patients undergoing PCI gained a net clinical benefit at 15 months with prasugrel over standard-dose clopidogrel.

By TCT Daily Staff

Prasugrel was superior to standard-dose clopidogrel in preventing ischemic events after PCI in STEMI patients in the prospective, randomized TRITON-TIMI 38 STEMI trial. At 15 months, prasugrel showed a net clinical benefit over clopidogrel, Gilles Montalescot, MD, said.

Patients treated with prasugrel did not have more bleeding events than those treated with clopidogrel; this was true for both major and minor bleeding in both primary and secondary PCI.

For the primary endpoint of cardiovascular death, MI or stroke at 15 months, the relative risk reduction (RRR) with prasugrel vs. clopidogrel was 21% (P=.02), with a significant difference noted as early as 30 days after PCI. For the secondary endpoint of cardiovascular death, MI, and urgent TVR at 30 days, the RRR with prasugrel was 25% (P=.02).

The occurrence of definite/probable stent thrombosis at 15 months was lower with prasugrel (see Figure).

Differences between the treatment groups in all types of bleeding events at 15 months, including TIMI major non-CABG bleeding and TIMI life-threatening non-CABG bleeding, were not statistically significant. Differences in TIMI major or minor non-CABG bleeding were also not significantly different at 30 days.

Montalescot said clopidogrel is effective in preventing ischemic events after stent placement, but at standard dosing levels it can have a slow onset of action and a low level of inhibition. Previous studies such as RELOAD and ALBION have shown increased levels of platelet aggregation with higher doses of clopidogrel.

TRITON-TIMI 38 compared clopidogrel to prasugrel in STEMI patients undergoing primary PCI who presented 12 hours or less after onset of symptoms, or secondary PCI when they presented late.

The trial included a total of 13,608 patients with moderate- to high-risk acute coronary syndrome undergoing PCI. Of 3,534 patients with PCI, 2,438 (69%) underwent primary PCI, and 1,094 (31%) underwent secondary PCI. Baseline history of diabetes, CABG, and multivessel PCI were similar in the two groups.

"These data make prasugrel an especially attractive alternative to clopidogrel in PCI for STEMI," Montalescot said.

Disclosures:

• Dr. Montalescot reported that he has received institutional research grants, consulting, and/or speaker fees from Daiichi Sankyo, Eli Lilly, and Sanofi-Aventis.

• The TRITON-TIMI 38 trial is supported by Daiichi Sankyo and Eli Lilly.