Thomas Vanassche1, Peter Verhamme1, Sonia S Anand2, Olga Shestakovska2, Keith Aa Fox3, Deepak L Bhatt4, Alvaro Avezum5, Marco Alings6, Victor Aboyans7, Aldo P Maggioni8, Petr Widimsky9, Scott D Berkowitz10, Salim Yusuf2, Stuart J Connolly2, John W Eikelboom2, Jackie Bosch2,11. 1. Department of Cardiovascular Sciences, University Hospitals Leuven, Belgium. 2. Population Health Research Institute, McMaster University and Hamilton Health Sciences, Canada. 3. Centre for Cardiovascular Science, University of Edinburgh, UK. 4. Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, USA. 5. Instituto Dante Pazzanese de Cardiologia, Brazil. 6. Amphia Ziekenhuis and Werkgroep Cardiologische Centra Nederland, the Netherlands. 7. Department of Cardiology, Dupuytren University Hospital, France. 8. Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Italy. 9. Cardiocenter, Charles University and University Hospital Kralovske Vinohrady, Czech Republic. 10. Research & Development Pharmaceuticals, Bayer U.S. LLC, USA. 11. School of Rehabilitation Science, McMaster University, Canada.
Abstract
AIMS: Secondary prevention in patients with coronary artery disease and peripheral artery disease involves antithrombotic therapy and optimal control of cardiovascular risk factors. In the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) study, adding low-dose rivaroxaban on top of aspirin lowered cardiovascular events, but there is limited data about risk factor control in secondary prevention. We studied the association between risk factor status and outcomes, and the impact of risk factor status on the treatment effect of rivaroxaban, in a large contemporary population of patients with coronary artery disease or peripheral artery disease. METHODS AND RESULTS: We reported ischemic events (cardiovascular death, stroke, or myocardial infarction) in participants from the randomized, double-blind COMPASS study by individual risk factor (blood pressure, smoking status, cholesterol level, presence of diabetes, body mass index, and level of physical activity), and by number of risk factors. We compared rates and hazard ratios of patients treated with rivaroxaban plus aspirin vs aspirin alone within each risk factor category and tested for interaction between risk factor status and antithrombotic regimen. Complete baseline risk factor status was available in 27,117 (99%) patients. Status and number of risk factors were both associated with increased risk of ischemic events. Rates of ischemic events (hazard ratio 2.2; 95% confidence interval 1.8-2.6) and cardiovascular death (hazard ratio 2.0; 1.5-2.7) were more than twofold higher in patients with 4-6 compared with 0-1 risk factors (p < 0.0001 for both). Rivaroxaban reduced event rates independently of the number of risk factors (p interaction 0.93), with the largest absolute benefit in patients with the highest number of risk factors. CONCLUSION: More favorable risk factor status and low-dose rivaroxaban were independently associated with lower risk of cardiovascular events.
RCT Entities:
AIMS: Secondary prevention in patients with coronary artery disease and peripheral artery disease involves antithrombotic therapy and optimal control of cardiovascular risk factors. In the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) study, adding low-dose rivaroxaban on top of aspirin lowered cardiovascular events, but there is limited data about risk factor control in secondary prevention. We studied the association between risk factor status and outcomes, and the impact of risk factor status on the treatment effect of rivaroxaban, in a large contemporary population of patients with coronary artery disease or peripheral artery disease. METHODS AND RESULTS: We reported ischemic events (cardiovascular death, stroke, or myocardial infarction) in participants from the randomized, double-blind COMPASS study by individual risk factor (blood pressure, smoking status, cholesterol level, presence of diabetes, body mass index, and level of physical activity), and by number of risk factors. We compared rates and hazard ratios of patients treated with rivaroxaban plus aspirin vs aspirin alone within each risk factor category and tested for interaction between risk factor status and antithrombotic regimen. Complete baseline risk factor status was available in 27,117 (99%) patients. Status and number of risk factors were both associated with increased risk of ischemic events. Rates of ischemic events (hazard ratio 2.2; 95% confidence interval 1.8-2.6) and cardiovascular death (hazard ratio 2.0; 1.5-2.7) were more than twofold higher in patients with 4-6 compared with 0-1 risk factors (p < 0.0001 for both). Rivaroxaban reduced event rates independently of the number of risk factors (p interaction 0.93), with the largest absolute benefit in patients with the highest number of risk factors. CONCLUSION: More favorable risk factor status and low-dose rivaroxaban were independently associated with lower risk of cardiovascular events.
Authors: Fernando A Ynsaurriaga; Vivencio Barrios; Marisol B Amaro; Julio Martí-Almor; Juan G Martínez; José A A Duque; Martín Ruiz-Ortiz; Rafael Vázquez-García; Alfonso V Muñoz Journal: Curr Cardiol Rev Date: 2021