TRITON-TIMI 38
Trial question
What is the role of prasugrel in patients with moderate-to-high-risk acute coronary syndromes with scheduled PCI?
Study design
Multi-center
Quadruple blinded
RCT
Population
Characteristics of study participants
26.0% female
74.0% male
N = 13608
13608 patients (3538 female, 10070 male).
Inclusion criteria: patients with moderate-to-high-risk acute coronary syndromes with scheduled PCI.
Key exclusion criteria: an increased risk of bleeding, anemia, thrombocytopenia, a history of pathologic intracranial findings, or the use of any thienopyridine within 5 days before enrollment.
Interventions
N=6813 prasugrel (a 60-mg loading dose and a 10-mg daily maintenance dose for 6-15 months).
N=6795 clopidogrel (a 300-mg loading dose and a 75-mg daily maintenance dose for 6 to 15 months).
Primary outcome
CV death, nonfatal MI, or nonfatal stroke
9.9%
12.1%
12.1 %
9.1 %
6.0 %
3.0 %
0.0 %
Prasugrel
Clopidogrel
Significant
decrease ▼
NNT = 45
Significant decrease in CV death, nonfatal MI, or nonfatal stroke (9.9% vs. 12.1%; HR 0.81, 95% CI 0.73 to 0.9).
Secondary outcomes
Significant decrease in nonfatal MI (7.3% vs. 9.5%; HR 0.76, 95% CI 0.67 to 0.85).
Safety outcomes
No significant differences in nonfatal bleeding (1.1% vs. 0.9%, p=0.23).
Significant differences in major bleeding (2.4% vs. 1.8%, p = 0.03; HR 1.32, 95% CI 1.03-1.68), life-threatening bleeding (1.4% vs. 0.9%, p = 0.01), including fatal bleeding (0.4% vs. 0.1%, p = 0.002).
Conclusion
In patients with moderate-to-high-risk acute coronary syndromes with scheduled PCI, prasugrel was superior to clopidogrel with respect to CV death, nonfatal MI, or nonfatal stroke.
Reference
Wiviott SD, Braunwald E, McCabe CH et al. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2007 Nov 15;357(20):2001-15.
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