6/28/23, 12:16 AM COMPASS-NCB Pathway Feedback Search Clinical Topics Home Studies COMPASS NCB COMPASS NCB Disease Disease Disease Acute ischemic stroke Coronary artery disease Periphe 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 N = 18278 78.0% male 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 cardiovascular death, stroke, myocardial infarction, fatal bleeding, or symptomatic bleeding into a critical organ https://web.pathway.md/studies/reczGHeIRqssZqAPa 1/2 6/28/23, 12:16 AM COMPASS-NCB Pathway 3.1 % / y 3.1 2.5 2.3 % / y 1.6 % / y 0.8 % / y Significant decrease 0.0 % / y Low-dose rivaroxaban plus aspirin Aspirin monotherapy Significant decrease in the incidence of cardiovascular death, stroke, myocardial infarction, 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 cardiovascular 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 myocardial infarction (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 cardiovascular death, stroke, myocardial infarction, 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. Open reference URL https://web.pathway.md/studies/reczGHeIRqssZqAPa 2/2