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Trial question
What is the effect of ticagrelor in patients with symptomatic PAD?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
28.0% female
72.0% male
N = 13885
13885 patients (3888 female, 9997 male).
Inclusion criteria: patients with symptomatic PAD who had an ankle-brachial index of ≤ 0.80 or had undergone previous revascularization of the lower limbs.
Key exclusion criteria: current or planned use of dual antiplatelet therapy or aspirin, an increased risk of bleeding, treatment with long-term anticoagulation, or a poor clopidogrel metabolizer status for the cytochrome P-450 2C19 allele.
Interventions
N=6930 ticagrelor (90 mg BID).
N=6955 clopidogrel (75 mg once daily).
Primary outcome
CV death, MI, or ischemic stroke
10.8%
10.6%
10.8 %
8.1 %
5.4 %
2.7 %
0.0 %
Ticagrelor
Clopidogrel
No significant difference ↔
No significant difference in CV death, MI, or ischemic stroke (10.8% vs. 10.6%; HR 1.02, 95% CI 0.92 to 1.13).
Secondary outcomes
No significant difference in acute limb ischemia (1.7% vs. 1.7%; HR 1.03, 95% CI 0.79 to 1.33).
Safety outcomes
No significant differences in major bleeding (1.6% in each group, p=0.49; HR 1.10, 95% CI 0.84-1.43).
Conclusion
In patients with symptomatic PAD who had an ankle-brachial index of ≤ 0.80 or had undergone previous revascularization of the lower limbs, ticagrelor was not superior to clopidogrel with respect to CV death, MI, or ischemic stroke.
Reference
Hiatt WR, Fowkes FG, Heizer G et al. Ticagrelor versus Clopidogrel in Symptomatic Peripheral Artery Disease. N Engl J Med. 2017 Jan 5;376(1):32-40.
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