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Rivaroxaban Plus Aspirin for Vascular Disease and Renal Dysfunction
Study Questions:
What is the safety and efficacy of dual pathway antithrombotic therapy (rivaroxaban 2.5 mg BID plus aspirin 81 mg daily) for patients with vascular disease and renal dysfunction?
Methods:
The authors performed a secondary analysis of the COMPASS trial, which included 27,395 patients with chronic coronary or peripheral artery disease randomized to very low dose rivaroxaban plus aspirin, rivaroxaban alone, or aspirin alone. Patients were stratified based on the presence/absence of chronic kidney disease, defined as a baseline glomerular filtration rate (GFR) ≥60 ml/min. The primary efficacy outcome was the combination of cardiovascular death, myocardial infarction, or stroke. The primary safety endpoint was major bleeding.
Results:
There were 21,111 patients with GFR ≥60 ml/min and 6,276 patients with a GFR<60 ml/min. Both the composite efficacy outcome and the safety outcome of major bleeding were more common in patients with renal dysfunction. The composite efficacy outcome was reduced with the combination of rivaroxaban plus aspirin as compared to aspirin alone in both patients with normal renal function (3.5% vs. 4.5%, hazard ratio [HR], 0.76; 95% confidence interval [CI], 0.64-0.90) and patients with reduced renal function (6.4% vs. 8.4%, 95% CI, 0.60-0.94). Major bleeding was more frequent with rivaroxaban plus aspirin as compared to aspirin alone in patients with normal renal function (2.9% vs. 1.6%, HR, 1.81; 95% CI, 1.44-2.28) and in patients with reduced renal function (3.9% vs. 2.7%, HR, 1.47; 95% CI, 1.05-2.07).
Conclusions:
The authors concluded that the benefits of dual pathway antithrombotic therapy in patients with chronic coronary or peripheral artery disease were preserved in patients with moderate renal dysfunction. They also note that there was not a disproportionally elevated risk of bleeding in patients with renal dysfunction.
Perspective:
It is well known that patients with moderate-severe renal dysfunction experience both higher rates of bleeding and thrombotic events. Given the modest increase in bleeding associated with combination rivaroxaban plus aspirin in the overall COMPASS trial population, the authors sought to explore if the efficacy and/or bleeding risks were significantly different between patients with normal or abnormal renal function. While overall rates of both bleeding and thrombotic events were higher in patients with at least moderate renal dysfunction, the relative benefit of rivaroxaban + aspirin therapy was preserved. Of note, patients with GFR <15 ml/min were excluded from the COMPASS trial and few patients with GFR <30 ml/min were included in the study. Overall, the dual antithrombotic pathway of very low dose rivaroxaban (2.5 mg BID) plus aspirin 81 mg daily may offer benefit for select patients with chronic coronary or peripheral artery disease at high risk for thrombotic complications but without significant bleeding risk, even if they have moderate renal dysfunction.
Clinical Topics: Anticoagulation Management, Cardiovascular Care Team, Prevention, Vascular Medicine, Atherosclerotic Disease (CAD/PAD)
Keywords: Anticoagulants, Aspirin, Fibrinolytic Agents, Glomerular Filtration Rate, Hemorrhage, Kidney Diseases, Myocardial Infarction, Peripheral Arterial Disease, Renal Insufficiency, Chronic, Secondary Prevention, Stroke, Vascular Diseases
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