TRITON-TIMI 38 (Trial to Assess

Improvement in Therapeutic Outcomes by

Optimizing Platelet Inhibition with

Prasugrel-Thrombolysis In Myocardial

Infarction)

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

• 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

S Wiviott (Brigham and Women's Hospital, Boston, MA) American Heart Association 2007 Scientific Sessions

End point

Prasugrel

(n=6813), %

Clopidogrel

(n=6795), %

Hazard ratio

(95% CI)

p

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

Major efficacy results at 15 months

•Prasugrel significantly reduced the primary efficacy end point, as well as some

key secondary end points (MI, TVR, and stent thrombosis) vs clopidogrel

TRITON-TIMI 38: Results (efficacy)

TVR=target vessel revascularization

End point

Prasugrel

(n=6813), %

Clopidogrel

(n=6795), %

Hazard ratio

(95% CI)

p

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

Major bleeding results at 15 months

•There were significant increases in major bleeding, life-threatening bleeding,

and fatal bleeding with prasugrel vs clopidogrel

TRITON-TIMI 38: Results (safety)

a. Relates to the number of patients who underwent CABG (179 in the prasugrel group and 189 in the

clopidogrel group)

TRITON-TIMI 38: Commentary*

*All comments from TRITON-TIMI 38: Prasugrel lowers events but ups bleeding vs clopidogrel

(http://www.theheart.org/article/823247.do)

"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

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