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

Abstract

Abstract 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