DAPT
Trial question
What is the role of dual antiplatelet therapy beyond 12 months in patients who had undergone a coronary stent procedure in which drug-eluting stent was placed?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
25.0% female
75.0% male
N = 9961
9961 patients (2526 female, 7435 male).
Inclusion criteria: patients who underwent a coronary stent procedure in which a drug-eluting stent was placed and who were treated with a thienopyridine drug (clopidogrel or prasugrel) and aspirin for 12 months.
Key exclusion criteria: pregnant women, concurrent medical condition with a life expectancy of < 3 years, index procedure stent placement with stent diameter < 2.25 mm or > 4.0 mm, long-term warfarin therapy, hypersensitivity or allergy to one of the study drugs.
Interventions
N=5020 continued thienopyridine (continued clopidogrel or prasugrel plus aspirin for 18 months).
N=4941 placebo (aspirin therapy alone for 18 months).
Primary outcome
Stent thrombosis
0.4%
1.4%
1.4 %
1.0 %
0.7 %
0.3 %
0.0 %
Continued
thienopyridine
Placebo
Significant
decrease ▼
NNT = 100
Significant decrease in stent thrombosis (0.4% vs. 1.4%; HR 0.29, 95% CI 0.17 to 0.48).
Secondary outcomes
Significant decrease in major adverse cardiovascular and cerebrovascular events (4.3% vs. 5.9%; HR 0.71, 95% CI 0.59 to 0.85).
Significant decrease in MI (2.1% vs. 4.1%; HR 0.47, 95% CI 0.37 to 0.61).
Borderline significant increase in death from any cause (2% vs. 1.5%; HR 1.36, 95% CI 1 to 1.85).
Safety outcomes
Significant differences in moderate or severe bleeding (2.5% vs. 1.6%, p = 0.001).
Conclusion
In patients who underwent a coronary stent procedure in which a drug-eluting stent was placed and who were treated with a thienopyridine drug (clopidogrel or prasugrel) and aspirin for 12 months, continued thienopyridine was superior to placebo with respect to stent thrombosis.
Reference
Mauri L, Kereiakes DJ, Yeh RW et al. Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents. N Engl J Med. 2014 Dec 4;371(23):2155-66.
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