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Randomized Controlled Trial
. 2025 Jan-Dec:31:10760296251372934.
doi: 10.1177/10760296251372934. Epub 2025 Oct 23.

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

Karen Falcão Britto  1 , Roberto Augusto Caffaro  1 , Giuliano Giova Volpiani  1 , Maria Fernanda Portugal  2 , Samantha Neves  1 , Alexia Paganotti  1 , Felipe Menegueti Pereira  1 , Leandro Barile Agati  3 , Camilla M Ribeiro  3 , Viviane Santana da Silva  3 , Emily Krupa  4 , Isabela Rodrigues Tavares  1 , Fakiha Siddiqui  5 , Jawed Fareed  4 , Valeria Cristina Resende Aguiar  6 , Walkiria Bernardi Hueb  1 , John W Eikelboom  7 , Sonia S Anand  7 , Renato D Lopes  8 , Eduardo Ramacciotti  3   4   6
Affiliations
Randomized Controlled Trial

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

Karen Falcão Britto et al. Clin Appl Thromb Hemost. 2025 Jan-Dec.

Abstract

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.

Keywords: biomarkers; intermittent claudication; peripheral artery disease; rivaroxaban.

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Conflict of interest statement

Declaration of Conflicting InterestsThe authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: The COMPASS CLAUDICATION trial was investigator-initiated research with financial support from BAYER S.A. ER discloses research grants and consulting fees from Bayer, Novartis, and Pfizer, grants from the Brazilian Ministry of Science and Technology, and personal fees (educational) from Aché Pharma, Sanofi, and Daiichi Sankyo. SSA reports honoraria and consultancy fees from Bayer and Janssen. John Eikelboom has received honoraria and/ or research funding from Bayer, BI, BMS, DSI, Janssen, Merck, Pfizer, and Servier. RDL reports grants and personal fees from Bristol Myers Squibb, Pfizer, GlaxoSmithKline, Medtronic PLC, and Sanofi and personal fees from Amgen, Bayer, and Boehringer Ingelheim, outside of the submitted work. The remaining authors have no conflicts of interest to declare.

Figures

Figure 1.
Figure 1.
The CONSORT Diagram.
Figure 2.
Figure 2.
Intergroup Statistical Evaluation of Biomarker Variations at Baseline and 24 Weeks Using the Shapiro-Wilk Test in the Aspirin and Rivaroxaban with Aspirin Groups.
Figure 3.
Figure 3.
Boxplot of Thrombin Levels in the Rivaroxaban and Aspirin Intragroup at Baseline, 12 and 24 Weeks.
See this image and copyright information in PMC

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