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Rivaroxaban Plus Aspirin Versus Aspirin in Relation to Vascular Risk in the COMPASS Trial
Sonia S Anand1, John W Eikelboom1, Leanne Dyal2
1Department of Medicine, Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada.
Insights
Low-dose rivaroxaban and aspirin significantly reduced vascular events in stable vascular disease patients. Risk stratification identified higher-risk individuals, optimizing treatment benefits for preventing recurrent events.
Area of Science:
- Cardiology
- Vascular Medicine
- Pharmacology
Background:
- The COMPASS trial demonstrated that combining low-dose rivaroxaban with aspirin effectively reduces major vascular events in patients with stable vascular disease.
- Identifying specific patient subsets at higher risk for recurrent vascular events is crucial for optimizing antithrombotic therapy.
Purpose of the Study:
- To identify patient subgroups at increased risk of recurrent vascular events within the COMPASS trial cohort.
- To guide the focused application of rivaroxaban and aspirin therapy based on individual patient risk profiles.
Main Methods:
- Risk stratification of COMPASS patients with vascular disease using the REACH (REduction of Atherothrombosis for Continued Health) score and CART (Classification and Regression Tree) analysis.
- Comparison of rivaroxaban plus aspirin versus aspirin alone over 30 months, assessing composite vascular events, severe bleeding, and net clinical benefit.
Main Results:
- Rivaroxaban and aspirin combination reduced serious vascular events by 25% (HR: 0.75; 95% CI: 0.66-0.85), preventing 23 events per 1,000 patients over 30 months.
- A non-significant 34% increase in severe bleeding was observed (IRR: 1.34; 95% CI: 0.95-1.88), representing 2 additional events per 1,000 patients.
- In high-risk patients (≥1 high-risk feature by CART analysis), rivaroxaban and aspirin prevented 33 serious vascular events, compared to 10 events per 1,000 in lower-risk patients.
Conclusions:
- Risk stratification, using criteria such as ≥2 vascular beds affected, heart failure, renal insufficiency, or diabetes, can identify higher-risk patients with vascular disease.
- The net clinical benefit of rivaroxaban and aspirin remains favorable for the majority of patients compared to aspirin monotherapy.
Background:
The COMPASS (Cardiovascular Outcomes for People Using Anticoagulation Strategies) trial showed that the combination of low-dose rivaroxaban and aspirin reduced major vascular events in patients with stable vascular disease.
Objectives:
The purpose of this study was to identify subsets of patients at higher risk of recurrent vascular events, which may help focus the use of rivaroxaban and aspirin therapy.
Methods:
COMPASS patients with vascular disease were risk stratified using 2 methods: the REACH (REduction of Atherothrombosis for Continued Health) atherothrombosis risk score and CART (Classification and Regression Tree) analysis. The absolute risk differences for rivaroxaban with aspirin were compared to aspirin alone over 30 months for the composite of cardiovascular death, myocardial infarction, stroke, acute limb ischemia, or vascular amputation; for severe bleeding; and for the net clinical benefit.
Results:
High-risk patients using the REACH score were those with 2 or more vascular beds affected, history of heart failure (HF), or renal insufficiency, and by CART analysis were those with ≥2 vascular beds affected, history of HF, or diabetes. Rivaroxaban and aspirin combination reduced the serious vascular event incidence by 25% (4.48% vs. 5.95%, hazard ratio: 0.75; 95% confidence interval: 0.66 to 0.85), equivalent to 23 events prevented per 1,000 patients treated for 30 months, at the cost of a nonsignificant 34% increase in severe bleeding (1.34; 95% confidence interval: 0.95 to 1.88), or 2 events caused per 1,000 patients treated. Among patients with ≥1 high-risk feature identified from the CART analysis, rivaroxaban and aspirin prevented 33 serious vascular events, whereas in lower-risk patients, rivaroxaban and aspirin treatment led to the avoidance of 10 events per 1,000 patients treated for 30 months.
Conclusions:
In patients with vascular disease, further risk stratification can identify higher-risk patients (≥2 vascular beds affected, HF, renal insufficiency, or diabetes). The net clinical benefit remains favorable for most patients treated with rivaroxaban and aspirin compared with aspirin.
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