Biomarker Analysis from the Compass Claudication Study - Rivaroxaban for Intermittent Claudication.

IntroductionA prospective, randomized, multicenter study compared rivaroxaban 2.5 mg twice daily plus aspirin 100 mg once daily against aspirin 100 mg once daily alone in patients with peripheral artery disease and intermittent claudication. The study demonstrated that rivaroxaban plus aspirin improved total walking distance. A better comprehension of coagulation and inflammatory biomarkers could serve as a prognostic indicator and inform clinical decision-making.MethodsThis is a subsequent biomarker analysis, including 36 patients from both arms and plasma from healthy controls. We used human plasma for comparison purposes of the baseline biomarkers for normality testing. Plasma levels of biomarkers relating to coagulation activation (DD, vWF, thrombin generation potential (TGP), fibrinolysis (PAI-1, TAFI) and inflammation (CRP) were assessed at baseline (day 0) and measured after 24 weeks.ResultsSamples from 16 patients allocated to the aspirin plus rivaroxaban group and 20 from the aspirin alone group were collected. No significant differences were observed in biomarkers between patients receiving rivaroxaban plus aspirin and those receiving aspirin alone.ConclusionThere were no differences in coagulation or inflammatory biomarkers in patients with intermittent claudication treated with either rivaroxaban plus aspirin or aspirin alone.