COMPASS-NCB
Trial question
What is the net clinical benefit of low-dose rivaroxaban plus aspirin in a prespecified subpopulation of patients with chronic vascular disease within the COMPASS study?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
22.0% female
78.0% male
N = 18278
18278 patients (4048 female, 14230 male).
Inclusion criteria: patients with chronic vascular disease.
Key exclusion criteria: a high bleeding risk; a recent stroke or previous hemorrhagic or lacunar stroke; severe HF; advanced stable kidney disease; use of dual antiplatelet therapy, anticoagulation, or other antithrombotic therapy.
Interventions
N=9152 low-dose rivaroxaban plus aspirin (rivaroxaban 2.5 mg BID plus aspirin 100 mg once daily).
N=9126 aspirin monotherapy (aspirin 100 mg alone).
Primary outcome
Incidence of CV death, stroke, MI, fatal bleeding, or symptomatic bleeding into a critical organ
2.5% / y
3.1% / y
3.1 % / y
2.3 % / y
1.6 % / y
0.8 % / y
0.0 % / y
Low-dose rivaroxaban plus
aspirin
Aspirin
monotherapy
Significant
decrease ▼
Significant decrease in the incidence of CV death, stroke, MI, fatal bleeding, or symptomatic bleeding into a critical organ (2.5% / y vs. 3.1% / y; HR 0.8, 95% CI 0.7 to 0.91).
Secondary outcomes
Significant decrease in the incidence of stroke (0.5% / y vs. 0.8% / y; HR 0.58, 95% CI 0.44 to 0.76).
Significant decrease in the incidence of CV death (0.9% / y vs. 1.2% / y; HR 0.78, 95% CI 0.64 to 0.96).
No significant difference in the incidence of MI (1% / y vs. 1.2% / y; HR 0.86, 95% CI 0.7 to 1.05).
Safety outcomes
No significant difference in fatal bleeding and symptomatic bleeding into critical organ.
Conclusion
In patients with chronic vascular disease, low-dose rivaroxaban plus aspirin was superior to aspirin monotherapy with respect to the incidence of CV death, stroke, MI, fatal bleeding, or symptomatic bleeding into a critical organ.
Reference
Jan Steffel, John W Eikelboom, Sonia S Anand et al. The COMPASS Trial: Net Clinical Benefit of Low-Dose Rivaroxaban Plus Aspirin as Compared With Aspirin in Patients With Chronic Vascular Disease. Circulation. 2020 Jul 7;142(1):40-48.
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