Why the study?
Identifying subsets of patients at higher risk of recurrent vascular events could help focus the use of rivaroxaban and aspirin therapy in stable vascular disease.
Does low-dose rivaroxaban plus aspirin reduce the composite of cardiovascular death, myocardial infarction, stroke, acute limb ischemia, or vascular amputation in patients with stable vascular disease compared to aspirin alone?
Does low-dose rivaroxaban plus aspirin reduce the composite of cardiovascular death, myocardial infarction, stroke, acute limb ischemia, or vascular amputation in patients with stable vascular disease compared to aspirin alone?
In patients with stable vascular disease, risk stratification identifies higher-risk subsets who derive greater absolute benefit from the combination of low-dose rivaroxaban and aspirin.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“We could think of these groups as the low-hanging fruit, and it will enable physicians to get started using this therapy because there is this concept of therapeutic inertia where, whenever there's a new medication or a new finding, it takes physicians time to get used to it in terms of understanding the data as well as getting their own experience using it in patients.”
“I think one of the problems we face these days is you have new exciting publications like COMPASS and then there's not a lot of uptake. And I think that's unfortunate because that means patients are going around untreated who might benefit from additional therapy and might in fact benefit a lot more by dual-pathway inhibition than by dual antiplatelet therapy. Changing how people think about that is always hard and these papers give us key risk enhancers that are easily clinically identified and allow you to make a decision to add low-dose rivaroxaban instead of a second antiplatelet drug and maybe even stop clopidogrel and switch to dual-pathway inhibition.”
“Whereas we might speculate about potentially safer or simpler options, the immediate challenge is to identify patients who are likely to gain survival advantage from the specific dual pathway regimen they validated. That regimen is not appropriate for every patient with atherosclerosis, but for many of those with diabetes, involvement of more than one vascular bed or ischemic heart disease underlying clinical heart failure, such treatment can begin today.”
Should not yet alter vascular prevention strategies; leaves open net benefit of rivaroxaban-aspirin in real-world practice.
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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Anand et al. (2019) studied this question.
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