200Safety of uninterrupted dabigatran in cardiovascular interventions in the GLORIA-AF registry program
Bibliographic record
Abstract
On behalf of: GLORIA-AF Investigators Funding Acknowledgements: The study was funded by Boehringer Ingelheim Background: Non-VKA oral anticoagulants (NOACs), such as dabigatran etexilate (DE), have become an important treatment option for patients with atrial fibrillation (AF). Cardiovascular (CV) interventions such as cardioversion and catheter ablation carry the risk of thromboembolic complications, while ablation is also associated with a risk of peri-procedural bleeding. A recent randomized, controlled clinical trial (RE-CIRCUIT) in patients undergoing AF ablation showed that an uninterrupted DE regimen was associated with fewer bleeding complications than uninterrupted warfarin with no difference in thromboembolic events1. Data from patients followed in routine clinical care inform clinical decision-making; however, prospectively collected data are not readily available. Purpose: This analysis describes the safety of uninterrupted DE for patients undergoing CV interventions in the prospectively collected clinical practice data from GLORIA-AF. Methods: GLORIA-AF is a prospective, observational, global registry program of consecutive patients with newly diagnosed non-valvular AF at risk of stroke. In Phase II of the program, DE patients were followed for 2-years. DE was prescribed and used at the discretion of treating physicians. CV interventions in patients on DE treatment that were performed without bridging, and for which information about the intra-procedure DE regimen (interrupted or uninterrupted) was available were included in the analysis. For the major subgroup of patients with an uninterrupted DE regimen, baseline characteristics, stroke/systemic embolism, and major bleeding up to 8 weeks after the intervention were described. Results: Patients were recruited at 982 sites in 44 countries from Nov 2011 to Dec 2014. During the 2-year follow-up of the 4859 eligible DE patients, 456 CV interventions were identified in the first DE treatment period. The majority of interventions (n=412) were performed with an uninterrupted DE regimen: 299 cardioversions, 38 catheter ablations, 25 pacemaker implantations, 26 angiographic procedures, 24 coronary/peripheral angioplasty ± stenting and other catheter-based interventions in 332 patients. Mean age of these patients was 67.2 (±9.6) years, 64.5% were male, 75.3% had hypertension, 28.6% heart failure and 20.8 % coronary disease. Mean CHA2DS2VASc score was 2.7 (±1.4). Within an average follow-up of 7.52 weeks after intervention, one major bleed and one systemic embolic event occurred on DE (risk 0.25% per intervention for both outcomes, 95% confidence interval (0.01%-1.36%). Conclusions: In this prospective analysis, the frequencies of major bleeding and stroke/systemic embolism following CV interventions with an uninterrupted DE regimen were very low. This supports the favorable safety and effectiveness profile of DE in clinical practice based settings, complementing randomized trial data. Reference: 1) Hugh Calkins et al. N Engl J Med 2017; 376:1627-1636
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".