http://www.theheart.org/web_slides/1144191.do A randomized to prasugrel or clopidogrel study on TRITON-TIMI 38 with patients who have moderate- to high-risk ACS.

1. TRITON-TIMI 38 (Trial to Assess
Improvement in Therapeutic Outcomes by
Optimizing Platelet Inhibition with
Prasugrel-Thrombolysis In Myocardial
Infarction)

2. TRITON-TIMI 38 (Trial to Assess Improvement in Therapeutic
Outcomes by Optimizing Platelet Inhibition with Prasugrel-
Thrombolysis In Myocardial Infarction)
S Wiviott (Brigham and Women's Hospital, Boston, MA)
American Heart Association 2007 Scientific Sessions
• Population and treatment:
13 608 moderate- to high-risk ACS patients scheduled for PCI
Randomized to prasugrel (60-mg loading dose and then 10-mg daily
maintenance dose) or clopidogrel (300-mg/75-mg) for six to 15 months
• Outcomes:
Primary efficacy end point: CV death/MI/stroke
Key safety end point: TIMI major bleeding not related to CABG

3. TRITON-TIMI 38: Results (efficacy)
• Prasugrel significantly reduced the primary efficacy end point, as well as some
key secondary end points (MI, TVR, and stent thrombosis) vs clopidogrel
Major efficacy results at 15 months
End point Prasugrel Clopidogrel Hazard ratio p
(n=6813), % (n=6795), % (95% CI)
CV death/MI/stroke 9.9 12.1 0.81 (0.73–0.90) <0.001
CV death 2.1 2.4 0.89 (0.70–1.12) 0.31
Nonfatal MI 7.3 9.5 0.76 (0.67–0.85) <0.001
Nonfatal stroke 1.0 1.0 1.02 (0.71–1.45) 0.93
Death from any cause 3.0 3.2 0.95 (0.78–1.16) 0.64
Urgent TVR 2.5 3.7 0.66 (0.54–0.81) <0.001
Stent thrombosis 1.1 2.4 0.48 (0.36–0.64) <0.001
TVR=target vessel revascularization

4. TRITON-TIMI 38: Results (safety)
• There were significant increases in major bleeding, life-threatening bleeding,
and fatal bleeding with prasugrel vs clopidogrel
Major bleeding results at 15 months
End point Prasugrel Clopidogrel Hazard ratio p
(n=6813), % (n=6795), % (95% CI)
Non–CABG-related TIMI major bleed 2.4 1.8 1.32 (1.03–1.68) 0.03
Life-threatening bleed 1.4 0.9 1.52 (1.08–2.13) 0.01
Fatal bleed 0.4 0.1 4.19 (1.58–11.11) 0.002
Major or minor TIMI bleeding 5.0 3.8 1.31 (1.11–1.56) 0.002
Bleed requiring transfusion 4.0 3.0 1.34 (1.11–1.63) <0.001
CABG-related TIMI major bleeda 13.4 3.2 4.73 (1.90–11.82) <0.001
a. Relates to the number of patients who underwent CABG (179 in the prasugrel group and 189 in the
clopidogrel group)

5. TRITON-TIMI 38: Commentary*
"Prasugrel appears to be particularly potent, with the danger of serious bleeding in
patients who undergo CABG or who have cerebrovascular disease. It will also be
interesting to see how well this drug is tolerated in the real treatment world."
- Dr Eric Topol
"The holy grail of antithrombotic drug development is balancing improved
efficacy against the risk of increased bleeding. It appears that prasugrel has fallen
short in this regard."
- Dr Sanjay Kaul
*All comments from TRITON-TIMI 38: Prasugrel lowers events but ups bleeding vs clopidogrel
(http://www.theheart.org/article/823247.do)

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