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

Camm, AJ; Amarenco, P; Haas, S; Hess, S; Kirchhof, P; Lambelet, M; Bach, M; Turpie, AGG; XANTUS Investigators (2019) Real-world vs. randomized trial outcomes in similar populations of rivaroxaban-treated patients with non-valvular atrial fibrillation in ROCKET AF and XANTUS. Europace, 21 (3). pp. 421-427. ISSN 1532-2092 https://doi.org/10.1093/europace/euy160
SGUL Authors: Camm, Alan John

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Abstract

Aims: Based on Phase III data, non-vitamin K antagonist oral anticoagulants are recommended for stroke prevention in patients with atrial fibrillation. To determine whether trial outcomes translate into similar event rates in unselected patients, this analysis compared outcomes from the real-world XANTUS study with those from the Phase III ROCKET AF study. Methods and results: Individual patient data from 4020 XANTUS patients were re-weighted to match the proportion of selected baseline characteristics in 7061 rivaroxaban-treated patients from ROCKET AF, using the matching-adjusted indirect comparison (MAIC) method. For the primary analysis, CHADS2 scores and gender were selected as relevant variables. Adjusted annualized incidence rates for XANTUS were calculated and compared with incidence rates from ROCKET AF-the ratio of these rates ('MAIC ratio') was used as a relative effect estimate. Rates of major bleeding [3.10%/year vs. 3.60%/year; MAIC ratio 0.86; 95% confidence interval (CI) 0.67-1.12] and stroke/non-central nervous system systemic embolism (1.54%/year vs. 1.70%/year; MAIC ratio 0.91; 95% CI 0.62-1.32) were similar between XANTUS and ROCKET AF. The rate of all-cause death was higher in XANTUS (3.22%/year vs. 1.87%/year; MAIC ratio 1.72; 95% CI 1.31-2.27), but the rates of vascular death were similar (1.83%/year vs. 1.53%/year; MAIC ratio 1.19; 95% CI 0.84-1.70). Sensitivity analyses weighted by different baseline characteristics supported these results. Conclusion: 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.

Item Type: Article
Additional Information: This is a pre-copyedited, author-produced version of an article accepted for publication in Europace following peer review. The version of record A John Camm, Pierre Amarenco, Sylvia Haas, Susanne Hess, Paulus Kirchhof, Marc Lambelet, Miriam Bach, Alexander G G Turpie; Real-world vs. randomized trial outcomes in similar populations of rivaroxaban-treated patients with non-valvular atrial fibrillation in ROCKET AF and XANTUS, EP Europace, Volume 21, Issue 3, 1 March 2019, Pages 421–427 is available online at: https://doi.org/10.1093/europace/euy160
Keywords: XANTUS Investigators, 1103 Clinical Sciences, Cardiovascular System & Hematology
SGUL Research Institute / Research Centre: Academic Structure > Molecular and Clinical Sciences Research Institute (MCS)
Journal or Publication Title: Europace
ISSN: 1532-2092
Language: eng
Dates:
DateEvent
1 March 2019Published
19 July 2018Published Online
6 July 2018Accepted
Publisher License: Publisher's own licence
PubMed ID: 30052894
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/110206
Publisher's version: https://doi.org/10.1093/europace/euy160

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