Strategies for the Management of Atrial Fibrillation in PatiEnts Receiving Dialysis (SAFE-D)
Bibliographic record
Abstract
Background: Atrial fibrillation (AF) is common in patients receiving maintenance dialysis. The role of oral anticoagulation (OAC) in this population is uncertain as dialysis recipients were excluded from landmark randomized control trials (RCTs). Methods: Objective: To investigate the feasibility of conducting a full-scale RCT to assess the efficacy and safety of OAC in dialysis recipients with AF. Design, setting, and participants: We conducted a parallel-group, open-label allocation- concealed pilot RCT from December 2019 to December 2022 at 28 centres in Canada and Australia (ClinicalTrials.gov Identifier: NCT03987711). We included adults (≥18 y) undergoing maintenance dialysis with a history of non-valvular AF who met CHADS-65 criteria (i.e. age ≥65 y or the presence of at least one stroke risk factor). Exclusion criteria included contraindications to warfarin or apixaban, the need for anticoagulation for conditions other than AF and lack of clinician equipoise. Interventions: Dialysis recipients were randomized 1:1:1, stratified by centre, to receive dose-adjusted warfarin (targeting an INR of 2-3), apixaban, or no OAC. Follow-up was 26 weeks. Outcomes: We identified two thresholds for feasibility: recruitment of the target population within 24 months and retention of ≥80% of participants in their allocated arm at the end of follow-up. Principal secondary outcomes were ischemic stroke or systemic embolism, and bleeding (defined by International Society of Thrombosis and Hemostasis criteria). Results: We screened 892 patients and enrolled 151(mean age 71.6 ± 10 y; 25% women; CHADS2-VASc score 4 (IQR 3-5); prior stroke, 13%, prior major bleeding, 9%) who were allocated to apixaban (n =51), warfarin (n=52) or no OAC (n=48). We completed recruitment in 30 months (allowing for pauses related to the pandemic) and 83% of participants completed follow-up in their allocated treatment arm. Stroke occurred in 2 participants (1 apixaban, 1 no OAC), and 27 participants had at least one bleeding event (12 warfarin, 8 apixaban, 7 no OAC) of which 8 were major (4 warfarin, 2 apixaban, 2 no OAC). Death occurred in 15 participants (9 warfarin, 2 apixaban, 4 no OAC). Time in the therapeutic range for warfarin users was 58% (IQR 47%-70%). Conclusions: This pilot RCT supports the feasibility of conducting a definitive RCT to inform the effect of OAC on clinical outcomes in dialysis recipients with AF. Funding: Government Support - Non-U.S.
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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 | 0.006 | 0.010 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.006 | 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".