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Association of Multiple Enrichment Criteria With Ischemic and Bleeding Risks Among COMPASS-Eligible Patients
Arthur Darmon1, Emmanuel Sorbets2, Gregory Ducrocq3
1FACT, French Alliance for Cardiovascular Trials, Département Hospitalo-Universitaire FIRE, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France.
Insights
Patients with stable vascular disease and multiple risk factors benefit more from increased ischemic protection than bleeding risk when treated with low-dose rivaroxaban and aspirin. This combination therapy may be suitable for high-risk individuals.
Area of Science:
- Cardiology
- Vascular Medicine
- Pharmacology
Background:
- The COMPASS trial demonstrated clinical benefits of low-dose rivaroxaban plus aspirin in stable vascular disease patients, but noted an increased bleeding risk.
- Understanding the balance between ischemic and bleeding risks is crucial for optimizing anticoagulation strategies.
Purpose of the Study:
- To evaluate the interplay of ischemic and bleeding risks in "COMPASS-eligible" patients based on the presence of specific enrichment criteria.
- To identify patient subgroups who may derive the most benefit from dual antithrombotic therapy.
Main Methods:
- A "COMPASS-eligible" population (n=16,875) was identified from the REACH Registry, comprising stable atherothrombotic patients.
- Ischemic outcomes included cardiovascular death, myocardial infarction, or stroke; bleeding outcomes comprised serious bleeding events.
- Patients were categorized based on enrichment criteria such as age, diabetes, renal failure, peripheral artery disease, smoking, heart failure, prior stroke, and carotid stenosis.
Main Results:
- Each enrichment criterion independently increased both ischemic and bleeding event rates.
- Patients with multiple enrichment criteria experienced a significantly greater absolute increase in ischemic risk compared to bleeding risk.
- For instance, those with ≥4 criteria showed a dramatic rise in ischemic risk (21.8%) versus a more modest increase in bleeding risk (3.2%).
Conclusions:
- In high-risk stable vascular patients, those with multiple enrichment criteria exhibit a more pronounced increase in ischemic risk than bleeding risk.
- This subgroup may represent ideal candidates for the addition of low-dose rivaroxaban to aspirin therapy.
- The findings support personalized risk-benefit assessments for anticoagulation in complex patient populations.
Background:
The COMPASS (Cardiovascular Outcomes for People Using Anticoagulation Strategies) trial found clinical benefit of low-dose rivaroxaban plus aspirin, but at the expense of increased bleeding risk in patients with stable vascular disease.
Objectives:
This study evaluated the balance of ischemic and bleeding risks according to the presence of ≥1 enrichment criteria in "COMPASS-eligible" patients.
Methods:
Key COMPASS selection criteria were applied to identify a COMPASS-eligible population (n = 16,875) from the REACH (REduction of Atherothrombosis for Continued Health) Registry of stable atherothrombotic patients. Ischemic outcome was the composite of cardiovascular death, myocardial infarction, or stroke. Bleeding outcome was serious bleeding (hemorrhagic stroke, hospitalization for bleeding, transfusion).
Results:
Patients were categorized according to the enrichment criteria: age >65 years (81.5%), diabetes (41.0%), moderate renal failure (40.2%), peripheral artery disease (33.7%), current smoker (13.8%), heart failure (13.3%), ischemic stroke (11.1%), and asymptomatic carotid stenosis (8.7%). Each criterion was associated with a consistent increase in ischemic and bleeding events, but no individual subgroup derived a more favorable trade-off. Patients with multiple criteria had a dramatic increase in ischemic risk (7.0% [95% confidence interval (CI): 5.6% to 8.7%], 12.5% [95% CI: 11.1% to 14.1%], 16.6% [95% CI: 14.7% to 18.6%], and 21.8% [95% CI: 19.9% to 23.9%] with 1, 2, 3, and ≥4 enrichment criteria, respectively), but a more modest absolute increase in bleeding risk (1.5% [95% CI: 0.9% to 2.1%], 1.8% [95% CI: 1.3% to 2.2%], 2.0% [95% CI: 1.5% to 2.6%], 3.2% [95% CI: 2.6% to 3.9%]).
Conclusions:
In a population of stable vascular patients at high risk of atherothrombotic events, the subset with multiple enrichment criteria had a greater absolute increase in ischemic than in bleeding risk and may be good candidates for low-dose rivaroxaban in addition to aspirin.
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