Author + information
- A. John Camm,
- Pierre Amarenco,
- Sylvia Haas,
- Susanne Hess,
- Paulus Kirchhof,
- Silvia Kuhls,
- Marc Lambelet,
- Martin van Eickels,
- Alexander Turpie and
- Bayer AG
Background: Rivaroxaban was noninferior to warfarin in stroke or systemic embolism prevention in patients with nonvalvular atrial fibrillation (NVAF) in the ROCKET AF randomized controlled trial. Real-world evidence from XANTUS in an unselected rivaroxaban-treated NVAF population also showed low rates of stroke and major bleeding. However, because ROCKET AF did not include patients with a CHADS2 score of 0 or 1, XANTUS results reflect a broader patient population. Therefore, safety and efficacy outcomes in XANTUS patients with a similar baseline risk were compared to those in ROCKET AF to assess concordance between clinical trial and real-world data.
Methods: Aggregated outcomes from 7,061 patients receiving rivaroxaban in ROCKET AF were compared with respective adjusted outcomes from 4,020 rivaroxaban-treated patients in XANTUS who were re-weighted to adjust for CHADS2 score (categories 2, 3 and 4-6) and gender differences. Weights were determined using the matching-adjusted indirect comparison (MAIC) method. This resulted in an estimated effective sample size of 2,492 XANTUS patients.
Results: Adjusted annualized incidence rates are presented for XANTUS and contrasted with those in ROCKET AF. Adjusted incidence rate of any treatment-emergent adjudicated major bleeding in XANTUS was similar to incidence rate in ROCKET AF (3.10% and 3.60%, respectively; MAIC rate ratio 0.86; 95% confidence interval [CI] 0.67-1.12). Rates of stroke or non-central nervous system embolism were also similar in XANTUS (adjusted rates) and ROCKET AF (1.54% vs 1.70%, respectively; MAIC rate ratio 0.91; 95% CI 0.62-1.32), as were myocardial infarction rates (adjusted rates for XANTUS) (0.75% vs 0.91%, respectively; MAIC rate ratio 0.82; 95% CI 0.49-1.39). However, adjusted all-cause mortality rate was higher in XANTUS than the rate in ROCKET AF (3.22% vs 1.87%, respectively; MAIC rate ratio 1.72; 95% CI 1.31-2.27), as could be expected in a real-life study that included patients with underlying conditions.
Conclusions: The low rates of major bleeding and stroke in the rivaroxaban-treated XANTUS population are generally consistent with results from ROCKET AF.
Poster Hall, Hall C
Saturday, March 18, 2017, 9:45 a.m.-10:30 a.m.
Session Title: Arrhythmias and Clinical EP: Anticoagulation Issues
Abstract Category: 6. Arrhythmias and Clinical EP: Other
Presentation Number: 1189-084
- 2017 American College of Cardiology Foundation