Real-world vs. randomized trial outcomes in similar populations of rivaroxaban-treated patients with non-valvular atrial fibrillation in ROCKET AF and XANTUS

Abstract

The low rates of major bleeding and stroke in XANTUS were consistent with results from ROCKET AF. All-cause death, but not vascular death, was higher in XANTUS, as expected in an unselected real-world population.

Rivaroxaban for non-valvular atrial fibrillation and venous thromboembolism in the Netherlands: a real-world data based cost-effectiveness analysis

“…We compared results from the total XANTUS population 20 to the Dutch XANTUS sub-population 33 , and found the number of major bleedings and thromboembolic events to be comparable (1.9% vs 2.1% and 1.6% vs 1.4%). The number of nonmajor bleedings was slightly lower in the total XANTUS population compared to the Dutch XANTUS sub-population: 12.9% vs 15.8% 25,33 . More non-major bleedings costs are higher, which makes the calculated ICER a conservative outcome.…”

“…Before adjustment, the rivaroxaban arm of the XANTUS trial comprised 60.5% of patients aged 75 years or greater and 25.5% between the age of 65 and 75. Of this same population, 50.6% had a CHADS 2 (Congestive Heart Failure, Hypertension, Age (!75 years), Diabetes Mellitus, prior Stroke/transient ischemic attack) score of 2, 27.6% had a score of 3, and 21.8% had a score of 4 or higher 25 . The transition probabilities in the NVAF model are shown in Appendix Table A3.…”

“…Data used for the transition probabilities of AF were corrected to reflect annual probabilities. Transition probabilities were based on a comparison of the XANTUS and ROCKET-AF studies 25 ; therefore, we only included the health states presented in this comparative study. Patient populations of the rivaroxaban arm of both studies were matched in order to account for the differences of the real life setting and that of the clinical trial 25 .…”

“…Transition probabilities were based on a comparison of the XANTUS and ROCKET-AF studies 25 ; therefore, we only included the health states presented in this comparative study. Patient populations of the rivaroxaban arm of both studies were matched in order to account for the differences of the real life setting and that of the clinical trial 25 . With this correction of the groups, represented as the Matching Adjusted Indirect Comparison (MAIC ratio), the rivaroxaban transition probabilities of the ROCKET-AF reflect the XANTUS results.…”

“…With this correction of the groups, represented as the Matching Adjusted Indirect Comparison (MAIC ratio), the rivaroxaban transition probabilities of the ROCKET-AF reflect the XANTUS results. Application of the MAIC ratio was only possible for primary end points listed by the study of Camm 25 ; i.e. ischemic stroke (IS), MB, MI, vascular death, death by any cause, and no event, as shown in Figure 2.…”