Risk factors and clinical outcomes in chronic coronary and peripheral artery disease: An analysis of the randomized, double-blind COMPASS trial
Language English Country Great Britain, England Media print-electronic
Document type Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
- Keywords
- Secondary prevention, blood pressure, cardiovascular risk factors, cholesterol, physical activity, rivaroxaban, smoking,
- MeSH
- Anticoagulants administration & dosage adverse effects MeSH
- Aspirin administration & dosage adverse effects MeSH
- Time Factors MeSH
- Chronic Disease MeSH
- Double-Blind Method MeSH
- Fibrinolytic Agents administration & dosage adverse effects MeSH
- Risk Assessment MeSH
- Factor Xa Inhibitors administration & dosage adverse effects MeSH
- Drug Therapy, Combination MeSH
- Middle Aged MeSH
- Humans MeSH
- Coronary Artery Disease diagnostic imaging drug therapy mortality MeSH
- Peripheral Arterial Disease diagnostic imaging drug therapy mortality MeSH
- Prospective Studies MeSH
- Recurrence MeSH
- Rivaroxaban administration & dosage adverse effects MeSH
- Heart Disease Risk Factors MeSH
- Secondary Prevention * MeSH
- Aged MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Names of Substances
- Anticoagulants MeSH
- Aspirin MeSH
- Fibrinolytic Agents MeSH
- Factor Xa Inhibitors MeSH
- Rivaroxaban MeSH
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.
Amphia Ziekenhuis and Werkgroep Cardiologische Centra Nederland the Netherlands
Associazione Nazionale Medici Cardiologi Ospedalieri Research Center Italy
Brigham and Women's Hospital Heart and Vascular Center Harvard Medical School USA
Cardiocenter Charles University and University Hospital Kralovske Vinohrady Czech Republic
Centre for Cardiovascular Science University of Edinburgh UK
Department of Cardiology Dupuytren University Hospital France
Department of Cardiovascular Sciences University Hospitals Leuven Belgium
Instituto Dante Pazzanese de Cardiologia Brazil
Population Health Research Institute McMaster University and Hamilton Health Sciences Canada
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