Physicians' Academy for Cardiovascular Education

Benefits of dual COMPASS regimen also seen in patients with moderate renal dysfunction

Rivaroxaban Plus Aspirin in Patients With Vascular Disease and Renal Dysfunction - From the COMPASS Trial

Literature - Fox KAA, Eikelboom JW, Shestakovska O et al., - J Am Coll Cardiol. 2019;73(18). DOI: 10.1016/j.jacc.2019.02.048

Introduction and methods

Chronic kidney disease (CKD) increases the risk of thromboembolism and bleeding, but anticoagulation therapy also increases bleeding risk in the presence of renal dysfunction [1-4]. Moreover, higher age and the prevalent comorbidities that are associated with vascular disease also negatively impact bleeding risk and adverse vascular outcomes. The extent of renal excretion of non-vitamin K antagonist oral anticoagulants varies, ranging from 25% to 80% of drug being excreted unchanged in the urine [5-7]. Thus, renal dysfunction may alter the risk-benefit balance for antithrombotic combinations.

The COMPASS study demonstrated that rivaroxaban 2.5 mg bd plus aspirin, compared with aspirin alone, reduced CV outcomes and increased major bleeding in patients with stable atherosclerotic vascular disease [8-10]. Rivaroxaban 5 mg twice daily on the other hand, did not reduce CV outcomes and was associated with higher bleeding risk [8].

This analysis assessed the safety and efficacy of low-dose anticoagulation with rivaroxaban plus aspirin (the dual pathway COMPASS regimen), compared with aspirin alone, in patients who are in sinus rhythm but at increased vascular risk, with or without moderate renal dysfunction. Patients in the COMPASS trial had chronic stable CAD and/or peripheral artery disease. 21.111 patients in the COMPASS population had GFR ≥60 mL/min at baseline and 6.275 had GFR <60 mL/min.

Main results


This analysis of COMPASS suggests that for both efficacy and safety, the relative treatment effects of the dual-pathway COMPASS regimen, consisting of rivaroxaban 2.5mg bd and aspirin, compared with aspirin alone, are consistent in those with preserved and moderately impaired renal function. A cut-off of GFR of 60 mL/min was used. Relatively few patients included in the COMPASS trial had GFR <30 mL/min, and by design, all had GFR >15 mL/min at baseline.


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