Efficacy and Safety of Low Dose Rivaroxaban in High Ischemic Risk Patients with Chronic Coronary Syndrome: Rationale and Design of the Dutch CCS Registry

Abstract

Abstract Background Despite advancements in secondary cardiovascular prevention, individuals with chronic coronary syndrome (CCS) still experience a lingering risk of adverse ischemic events. To minimize this residual risk by stabilizing and regressing the chronic disease process, there is consensus that antithrombotic therapy is crucial role for secondary cardiovascular prevention. The combination of low-dose rivaroxaban (2.5mg BID) with aspirin, known as dual-pathway inhibition, has emerged as a strategy to mitigate this residual risk and lower major adverse cardiovascular events (MACE). European guidelines, based on findings of the COMPASS trial, recommend incorporating low-dose rivaroxaban and aspirin into standard secondary prevention in CCS patients. However, real-world data on the impact of this approach are still lacking. Aim The primary objective of the DUTCH-CCS registry is to gather real-world data on the efficacy and safety of low-dose rivaroxaban in combination with aspirin among patients with CCS in the Netherlands. By conducting this registry, the aim is to bridge the gap in knowledge and provide insights into the practical outcomes and potential benefits or risks associated with the use of dual-pathway inhibition in a real-world clinical setting, beyond the confines of controlled clinical trials. Methods The DUTCH-CCS registry is a national, multicenter, prospective observational study, and aims to enroll 1000 adult CCS patients who are treated with rivaroxaban 2.5mg BID plus aspirin. The study focuses on high ischemic risk individuals with coronary artery disease (CAD) and/or peripheral artery disease, using a single-arm design. The primary effectiveness endpoint includes major adverse cardiac events (MACE), clinically driven coronary-, peripheral- or carotid revascularization, and stent thrombosis at 1-year follow-up, while the primary safety endpoint is major bleeding at 1-year. The study will collect outcome data at 3-month and 1-year follow-up. Conclusion The DUTCH-CCS registry holds the potential to enhance understanding of the real-world impact of low-dose rivaroxaban plus aspirin as a secondary prevention strategy in CCS patients. The findings may offer valuable insights into the efficacy and safety of dual-pathway inhibition, providing clinicians and researchers with data for informed treatment decisions and may refine guidelines for the management of CCS patients in everyday clinical practice. Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT04753372