Key result
In stable atherothrombotic patients, having ≥4 vs 1 enrichment criteria increased ischemic risk more than bleeding risk.
Why the study?
The COMPASS trial showed benefits of low-dose rivaroxaban plus aspirin alongside increased bleeding risk, prompting evaluation of the ischemic and bleeding balance according to enrichment criteria in COMPASS-eligible patients.
Does the presence of multiple enrichment criteria identify COMPASS-eligible patients with a greater absolute increase in ischemic risk compared to bleeding risk?
Observational (n=16,875)
Does the presence of multiple enrichment criteria identify COMPASS-eligible patients with a greater absolute increase in ischemic risk compared to bleeding risk?
In stable vascular patients, having multiple enrichment criteria is associated with a greater absolute increase in ischemic risk than bleeding risk, identifying a subgroup that may derive net benefit from low-dose rivaroxaban plus aspirin.
Answers are grounded in this paper and cite their sources.
≥4 enrichment criteria were associated with greater ischemic than bleeding risk; leaves open net benefit from rivaroxaban plus aspirin in COMPASS-eligible patients.
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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Darmon et al. (2019) conducted an observational in stable atherothrombotic patients (n=16,875). Multiple enrichment criteria vs. Fewer enrichment criteria was evaluated on composite of cardiovascular death, myocardial infarction, or stroke. In stable atherothrombotic patients, having ≥4 vs 1 enrichment criteria increased ischemic risk more than bleeding risk.
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