Indian Real-world Evidence of Rivaroxaban Use in Coronary Artery Disease – A Prospective Observational Cohort Study (IN-RECORD): Study Design and Baseline Characteristics

Abstract

Abstract Background: Antiplatelet therapy (APT) is the cornerstone for cardiovascular (CV) prevention in patients with coronary artery disease (CAD). However, there is potential for greater effectiveness in vascular prevention for patients with stable CAD or peripheral artery disease (PAD) through the use of rivaroxaban alone or in combination with aspirin, surpassing the benefits offered by aspirin alone. Materials and Methods: INdian Real world EvidenCe Of Rivaroxaban use in coronary artery Disease – A prospective observational cohort study (IN-RECORD) study is designed as a prospective, observational study. The objective of this study is to compare the real-world effectiveness and safety of rivaroxaban in combination with APT (dual pathway inhibition therapy [DPIT]) versus dual APT (DAPT) in Indian patients with CAD and peripheral arterial disease (PAD). The study will encompass multiple clinical sites across the Indian geography. The study’s primary outcome is the comparison of net clinical benefit between the two groups which is defined as the composite of effectiveness (reduction in incidence of CV death, stroke, and myocardial infarction [MI]) and safety (life-threatening or fatal bleeding). Results: From June 2021 to December 2022, we enrolled 374 patients from the participating sites from India. We enrolled 225 and 149 patients in the DAPT and DPIT groups, respectively. The mean observed age and weight at the baseline were 63.05 ± 10.09 years and 64.15 ± 11.43 kg, respectively. There was a male preponderance observed in the enrolled patients (males: 86.63%, females: 13.37%). The most frequent comorbidity observed in CAD patients was hypertension, followed by diabetes and MI. At baseline, a significant percentage of patients were taking antiplatelet medications besides aspirin. Conclusion: IN-RECORD will provide information on the efficacy and safety of rivaroxaban in combination with APT versus APT in the Indian patient population in real-life clinical scenario.