Efficacy and safety of direct oral anticoagulants in patients with device-detected atrial fibrillation with and without dose reduction criteria: a pooled analysis of ARTESiA and NOAH-AFNET 6
Bibliographic record
Abstract
Abstract Background In patients with device-detected atrial fibrillation (AF), direct oral anticoagulants (DOACs), as compared to aspirin or placebo, reduce thrombotic events and increase major bleeding. Purpose We explored whether the effects of DOAC differ according to whether patients with device-detected AF met dose adjustment criteria. Methods We performed pre-specified secondary analyses and a trial-level pooled analysis of the ARTESiA and NOAH-AFNET 6 randomized trials. We stratified analyses based on whether or not patients met DOAC dose reduction criteria. Results Among 4,012 patients in ARTESiA, 10.4% met apixaban dose reduction criteria. Among 2,354 patients in NOAH-AFNET 6, 28.4% met edoxaban dose reduction criteria. DOACs, as compared to aspirin or placebo, decreased the risk of a composite of all-cause stroke or systemic embolism both in patients with dose adjustment criteria (1.0% vs 2.0% per patient year; risk ratio [RR] 0.50, 95% confidence interval [CI] 0.26-0.97) and in those who met standard dose criteria (0.8% vs 1.2% per patient year, RR 0.69, 95% CI 0.51-0.94); there was no evidence of treatment interaction (p interaction = 0.38). DOACs tended to have a greater decrease in the risk of the composite of stroke, systemic embolism, myocardial infarction, pulmonary embolism or cardiovascular death in patients who were dose adjusted (4.0% vs 6.2% per patient year, RR 0.67, 95% CI 0.48-0.92) as compared to patients who received standard dose (2.7% vs 3.0% per patient year, RR 0.91, 95% CI 0.76-1.09); there was borderline significance for a subgroup effect (p interaction= 0.10). In NOAH-AFNET 6, patients fulfilling dose adjustment criteria had a greater benefit of edoxaban (p interaction = 0.03) than those fulfilling standard dose criteria. DOACs increased the risk of major bleeding both in patients who were dose adjusted (2.7% vs 2.0%, RR 1.35, 95% CI 0.83-2.21) and those who received standard dose (1.5% vs 0.9%, RR 1.69, 95% CI 1.04-2.75); (interaction p value = 0.52). Conclusions Patients with device-detected AF who meet DOAC dose-adjustment criteria have higher rates of stroke, bleeding and death than patients who meet standard dose criteria. Overall, the effect of DOAC for all outcomes is similar in both standard and reduced dose strata. There was for a possible greater absolute benefit for edoxaban against the stroke, systemic embolism, myocardial infarction, pulmonary embolism or cardiovascular death outcome in the reduced dose strata in the NOAH-AFNET 6 trial. This requires further study using patient-level data.
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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 | 0.014 | 0.019 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.013 | 0.033 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| 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".