Risk factors and clinical outcomes in chronic coronary and peripheral artery disease: An analysis of the randomized, double-blind COMPASS trial

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.

4112Risk factors and clinical outcomes in chronic CAD and PAD: an analysis of the randomized, double-blind COMPASS trial

Background Patients with coronary artery disease (CAD) and peripheral artery disease (PAD) are at high risk for cardiovascular death and ischemic events. Secondary prevention requires both optimal control of modifiable cardiovascular risk factors and antithrombotic therapy. The COMPASS study showed a reduction in ischemic events in patients treated with the combination of low-dose rivaroxaban and aspirin, compared with aspirin alone. However, the impact of intensifying antithrombotic therapy by baseline risk factor control is not well studied. Objective To study the association between baseline risk factor status and outcomes, and the effects of treatment with low-dose rivaroxaban and aspirin compared with aspirin alone according to baseline risk factors, in a large contemporary population of patients with CAD or PAD. Methods We studied ischemic events (cardiovascular death, stroke, or MI) in participants from the randomised, double blind COMPASS trial in relation to baseline blood pressure, smoking status, cholesterol level, presence of diabetes, body mass index, and level of physical activity, as well as by the number of cardiovascular risk factors (0–1, 2, 3, 4, or 5–6). Within each risk factor category, we compared rates and hazard ratios of patients treated with rivaroxaban plus aspirin vs aspirin alone and tested for interaction between the treatment effect of rivaroxaban and risk factor status. Results Baseline information on all six risk factors was available in 27,117 (99%) patients. Each risk factor was associated with increased risk of ischemic events (Figure 1, panel A). Patients with 5 or 6 risk factors had more than 2-fold higher rates of ischemic events (HR 2.36; 95% CI: 1.80–3.10) and of cardiovascular death (HR 2.22; 1.48–3.33) compared with patients with 0 or 1 risk factor. The addition of low-dose rivaroxaban on top of aspirin reduced event rates independently of number of risk factors (p for interaction 0.93) (Figure 1, panel B). The largest absolute benefit of low-dose rivaroxaban was seen in patients with the greatest number of risk factors. Figure 1 Conclusion More favourable baseline risk factor status and the use of low-dose rivaroxaban were both independently associated with lower risk of ischemic events. Patients at highest risk, based on number of baseline risk factors, derive the largest absolute benefit of the combination of rivaroxaban and aspirin. Acknowledgement/Funding The COMPASS trial was sponsored by Bayer AG. The sponsor did not influence the analysis plan, drafting of abstract, or the decision to submit

ELAPSS score for prediction of risk of growth of unruptured intracranial aneurysms

Objective:To develop a risk score that estimates 3-year and 5-year absolute risks for aneurysm growth.Methods:From 10 cohorts of patients with unruptured intracranial aneurysms and follow-up imaging, we pooled individual data on sex, population, age, hypertension, history of subarachnoid hemorrhage, and aneurysm location, size, aspect ratio, and shape but not on smoking during follow-up and family history of intracranial aneurysms in 1,507 patients with 1,909 unruptured intracranial aneurysms and used aneurysm growth as outcome. With aneurysm-based multivariable Cox regression analysis, we determined predictors for aneurysm growth, which were presented as a risk score to calculate 3-year and 5-year risks for aneurysm growth by risk factor status.Results:Aneurysm growth occurred in 257 patients (17%) and 267 aneurysms (14%) during 5,782 patient-years of follow-up. Predictors for aneurysm growth were earlier subarachnoid hemorrhage, location of the aneurysm, age >60 years, population, size of the aneurysm, and shape of the aneurysm (ELAPSS). The 3-year growth risk ranged from <5% to >42% and the 5-year growth risk from <9% to >60%, depending on the risk factor status.Conclusions:The ELAPSS score consists of 6 easily retrievable predictors and can help physicians in decision making on the need for and timing of follow-up imaging in patients with unruptured intracranial aneurysms.