Abstract 2860: Efficacy and Safety of Vernakalant Hydrochloride Injection for the Treatment of Atrial Fibrillation After Valvular or Coronary Artery Bypass Surgery
Bibliographic record
Abstract
Introduction: Postoperative atrial fibrillation (AF) and atrial flutter (AFL) are common after cardiac surgery. This study evaluated the efficacy and safety of vernakalant hydrochloride, a novel atrial selective, frequency- and voltage-dependent Na + and early activating K + channel blocker, in converting AF or AFL to normal sinus rhythm (SR) after coronary artery bypass surgery (CABG), valvular surgery, or both. Methods : This multicenter, double-blind, randomized, placebo-controlled trial included patients aged ≥18 years who had normal SR preceding surgery; had undergone CABG or valvular surgery; and had documented, sustained (3–72 hours) AF or AFL between 24 hours and 7 days after CABG or valvular surgery. Patients were randomly assigned in a 1:2 ratio to receive a 10-min infusion of placebo or vernakalant 3 mg/kg. After 15 min, a second 10-min infusion of placebo or vernakalant 2 mg/kg was given, if AF or AFL persisted. Postdose evaluations included 24-hr Holter monitoring, 12-lead ECG recordings, and assessment of vital signs and AF/AFL symptoms. The primary efficacy measure was conversion to SR for at least 1 minute within 90 min of first exposure. Results : Of 190 patients randomized, 161 received treatment (54 placebo and 107 vernakalant). The main reason for not receiving treatment was spontaneous conversion to SR (7 placebo and 17 vernakalant). Among the patients given treatment, 67% had undergone CABG, 24% had valvular surgery, and 9% had both. The mean age was 68 years, and most patients were men (75%) and white (94%). At entry, 93% of patients had AF, 6% had AFL, and 1% had neither. Conversion to SR within 90 minutes was observed in 45% of patients given vernakalant and 15% of those given placebo ( P = .0002). Of the patients converting to SR with vernakalant, the median time to conversion was 12 minutes and 75% converted on the first dose. In the 24-hr period following study drug administration, adverse events were reported in 32% and 38% of patients given placebo and vernakalant, respectively, of which 2 were serious (complete AV block and hypotension) in the vernakalant group. There were no deaths or cases of torsade de pointes. Conclusions : Vernakalant was effective and well tolerated in the conversion of AF and AFL to SR after CABG, valvular surgery, or both.
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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 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.007 | 0.001 |
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".