PLATO
Trial question
What is the effect of ticagrelor in patients with acute coronary syndromes?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
28.0% female
72.0% male
N = 18624
18624 patients (5288 female, 13336 male).
Inclusion criteria: patients admitted to the hospital with an acute coronary syndrome, with or without ST-segment elevation.
Key exclusion criteria: any contraindication against the use of clopidogrel, fibrinolytic therapy within 24 hours before randomization, need for oral anticoagulation therapy, increased risk of bradycardia, and concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer.
Interventions
N=9333 ticagrelor (180 mg loading dose, 90 mg BID thereafter).
N=9291 clopidogrel (300-600 mg loading dose, 75 mg daily thereafter).
Primary outcome
Death from vascular causes, MI, or stroke
9.8%
11.7%
11.7 %
8.8 %
5.8 %
2.9 %
0.0 %
Ticagrelor
Clopidogrel
Significant
decrease ▼
NNT = 52
Significant decrease in death from vascular causes, MI, or stroke (9.8% vs. 11.7%; HR 0.84, 95% CI 0.77 to 0.92).
Secondary outcomes
Significant decrease in MI (5.8% vs. 6.9%; HR 0.84, 95% CI 0.75 to 0.95).
Significant decrease in death from vascular causes (4% vs. 5.1%; HR 0.79, 95% CI 0.69 to 0.91).
Significant decrease in death from any cause (4.5% vs. 5.9%; HR 0.78, 95% CI 0.69 to 0.89).
Safety outcomes
No significant differences in rates of major bleeding (11.6% vs. 11.2%, p=0.43).
Significant differences in rates of major bleeding not related to CABG (4.5% vs. 3.8%, p = 0.03).
Conclusion
In patients admitted to the hospital with an acute coronary syndrome, with or without ST-segment elevation, ticagrelor was superior to clopidogrel with respect to death from vascular causes, MI, or stroke.
Reference
Wallentin L, Becker RC, Budaj A et al. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57.
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