Non-embolic outcomes in patients with cardiovascular disease and atrial fibrillation treated with rivaroxaban.

Aim: It is not well known how comorbidities may change the prognosis of atrial fibrillation (AF) patients. This study was aimed to analyze the impact of cardiovascular disease on this population. Materials & methods: EMIR was a multicenter, prospective study, including 1433 AF patients taking rivaroxaban for ≥6 months. Data were analyzed according to the presence of vascular disease. Results: Coronary artery disease was detected in 16.4%, peripheral artery disease/aortic plaque in 6.7%, vascular disease in 28.3%. Patients with coronary artery disease had higher rates (per 100 patient-years) of major adverse cardiovascular events (2.98 vs 0.71; p < 0.001) and cardiovascular death (1.79 vs 0.41; p = 0.004). Those with vascular disease had higher rates of thromboembolic events (1.47 vs 0.44; p = 0.007), major adverse cardiovascular events (2.03 vs 0.70; p = 0.004), and cardiovascular death (1.24 vs 0.39; p = 0.025). Patients with peripheral artery disease/aortic plaque had similar rates. Conclusion: AF patients with vascular disease have a higher risk of non-embolic outcomes.

Rivaroxaban for the prevention of outcomes in patients with atrial fibrillation in clinical practice: an indirect comparison of national and international registries.

Objective: To analyze the effectiveness and safety of rivaroxaban in patients with atrial fibrillation (AF). Methods: The clinical profile and outcomes of the EMIR study were indirectly compared with those of ROCKET-AF, eight other Spanish observational studies and XANTUS. Results: In EMIR, mean age was 74.2 years and CHA2DS2-VASc was 3.5. In the rivaroxaban arm of the ROCKET-AF trial, mean age was 73 years and CHADS2 was 3.5, whereas in the Spanish studies mean age ranged from 74.9 years to 78.4 years and CHA2DS2-VASc from 3.5 to 4.3. In EMIR, rates of stroke/systemic embolism, major adverse cardiovascular events, cardiovascular death and major bleeding were 0.57, 1.07, 0.63 and 1.04 events/100 patient-years, respectively. In ROCKET-AF, these numbers were 1.7, 3.91, 1.53 and 3.6 events/100 patient-years, respectively. In the Spanish studies, rates of stroke and major bleeding were 0-1.8 and 0.22-4.2 events/100 patient-years, respectively. In XANTUS, rates of stroke, major adverse cardiovascular events and major bleeding were 0.7, 1.8 and 2.1 events/100 patient-years, respectively. Conclusion: Despite the fact that rivaroxaban is prescribed for elderly patients with a high thromboembolic risk, rates of outcomes remain low.

Thromboembolic and bleeding events with rivaroxaban in clinical practice in Spain: impact of inappropriate doses (the EMIR study).

Aim: To analyze the frequency and variables related to inappropriate rivaroxaban dosage in clinical practice and its impact on outcomes after 2 years. Materials & methods: Postauthorization, observational, multicenter study, in which atrial fibrillation patients, treated with rivaroxaban ≥6 months were included. Results: A total of 1421 patients (74.2 ± 9.7 years, CHA2DS2-VASc 3.5 ± 1.6) were included. Overall, 22.9% received rivaroxaban 15 mg. The proper dose of rivaroxaban was taken by 83.3% (9.7% underdosed, 7.0% overdosed). Older age and renal insufficiency were associated with inadequate rivaroxaban dosage. There was a trend toward higher all-cause mortality among underdosed patients (adjusted hazard ratio 1.39; 95% CI 0.75-2.58), and more bleedings in overdosed patients (2.29 vs 0.80 events/100 patient-years; p = 0.14). Conclusion: In clinical practice, rivaroxaban is properly dosed in most patients.