ATLAS ACS 2-TIMI 51 (rivaroxaban 5 mg)
Trial question
What is the role of rivaroxaban in patients with a recent acute coronary syndrome?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
25.0% female
75.0% male
N = 10350
10350 patients (2593 female, 7757 male).
Inclusion criteria: patients with a recent acute coronary syndrome.
Key exclusion criteria: platelet count < 90,000/mm²; hemoglobin level < 10 g/dL; CrCl < 30 mL/min; clinically significant gastrointestinal bleeding in the past 12 months; previous ICH; previous ischemic stroke or TIA in patients who were taking both aspirin and a thienopyridine.
Interventions
N=5174 rivaroxaban (2.5 mg BID).
N=5176 placebo (matching placebo BID).
Primary outcome
CV death, MI, or stroke
9.1%
10.7%
10.7 %
8.0 %
5.3 %
2.7 %
0.0 %
Rivaroxaban
Placebo
Significant
decrease ▼
NNT = 62
Significant decrease in CV death, MI, or stroke (9.1% vs. 10.7%; HR 0.84, 95% CI 0.72 to 0.97).
Secondary outcomes
Significant decrease in CV death (2.7% vs. 4.1%; HR 0.66, 95% CI 0.51 to 0.86).
Significant decrease in death from any cause (2.9% vs. 4.5%; HR 0.68, 95% CI 0.53 to 0.87).
Safety outcomes
No significant difference in fatal bleeding or other adverse events.
Significant differences in major bleeding not related to CABG (1.8% vs. 0.6%, p < 0.001) and ICH (0.4% vs. 0.2%, p = 0.04).
Conclusion
In patients with a recent acute coronary syndrome, rivaroxaban was superior to placebo with respect to CV death, MI, or stroke.
Reference
Mega JL, Braunwald E, Wiviott SD et al. Rivaroxaban in patients with a recent acute coronary syndrome. N Engl J Med. 2012 Jan 5;366(1):9-19.
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