P300Impact of gender: rivaroxaban for patients with atrial fibrillation in the XANTUS real-world prospective study
Bibliographic record
Abstract
On behalf of: the XANTUS Investigators Funding Acknowledgements: Bayer AG Background: Gender differences in outcomes have been seen in patients with atrial fibrillation (AF). Overall in the phase III ROCKET AF randomized controlled trial of rivaroxaban versus warfarin in stroke or systemic embolism prevention in patients with nonvalvular AF, women had a higher risk of stroke but a lower risk of vascular death and bleeding events than men. Recent registry data have also shown that women had a higher risk of stroke than men. Purpose: This study aimed to analyse demographics and clinical characteristics, and assess the impact of gender on rates of thromboembolism, bleeding and death, in patients with nonvalvular AF specifically receiving rivaroxaban in routine clinical practice. Methods: XANTUS is an international, prospective, observational study of consecutive consenting patients with nonvalvular AF newly started on rivaroxaban who were followed up at 3-month intervals for 1 year, or at least 30 days after permanent discontinuation; mean treatment duration was 329 days. The XANTUS database was examined for demographics, clinical characteristics and outcomes by patient gender. All major outcomes (including major bleeding, symptomatic thromboembolic events [stroke, systemic embolism (SE), transient ischaemic attack, myocardial infarction (MI)], and death) were centrally adjudicated. Results: Among the 6,784 patients in the safety population, the analysis was conducted in 4,016 male (59.2%) and 2,765 female (40.8%) patients (missing values for 3 patients). Women were older than men (mean age 73.7 vs 70.0 years; p<0.0001) and were more likely to have age-related comorbidities (e.g. prior stroke/SE/transient ischaemic attack: 20.7% vs 17.9%; p=0.005); men were more likely to have had prior MI (12.8% vs 6.2%; p<0.0001). After adjustment for baseline characteristics, analysis of outcomes by gender showed a similar risk of stroke/SE in both men and women (hazard ratio [HR] 1.04; 95% confidence interval [CI] 0.59–1.84), and nonsignificant trends for men to be at lower risk of ischaemic stroke (HR=0.79; 95% CI 0.39–1.61). Nonsignificant trends were also seen for higher risk of major bleeding (HR=1.32; 95% CI 0.90–1.95) and MI (HR=1.17; 95% CI 0.51–2.68) in men. Conclusion: Unlike other AF populations reported in the literature, outcomes in patients with nonvalvular AF treated with rivaroxaban were generally similar between men and women in this real-world study.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".