P2300Vernakalant for cardioversion of recent-onset atrial fibrillation: a systematic review and meta-analysis
Bibliographic record
Abstract
Background: Vernakalant is a rapid-acting, atrial-selective anti-arrhythmic agent that has been approved for the pharmacological cardioversion of recent-onset atrial fibrillation (AF). Recently published clinical trials have provided new information on the efficacy and safety of this agent. Our objective was to determine if the rates of cardioversion within 90 minutes are different in patients with recent-onset AF who are treated with vernakalant as compared to placebo or active comparator. Methods: We searched MEDLINE, EMBASE and CENTRAL (inception to January 2018). We included randomized controlled trials comparing vernakalant with active medications or with placebo in patients with AF of onset within 7 days or less. We abstracted data and assessed the risk of bias in each study independently and in duplicate. We used a random-effects model to combine quantitative data. Quality of evidence was rated using GRADE. Results: From 414 total citations, we identified 9 trials comparing a total of 1314 patients. Six trials compared vernakalant to placebo, 2 trials compared vernakalant to ibutilide and 1 trial compared vernakalant to amiodarone. We found significant methodological bias in 4 of 9 trials (1 with pseudo-randomization, 2 with early termination, 1 with violation of the intention-to-treat principle). Visual inspection of funnel plots was suggestive of publication bias. Overall, vernakalant significantly increased the rate of conversion to sinus rhythm within 90 minutes (RR 5.23; 95% CI 2.25–12.15, I2 test for heterogeneity = 93%). We performed several pre-defined sensitivity analyses. In studies at low risk of bias, the rate of cardioversion was significantly increased with vernakalant (RR 5.98; 95% CI 1.91–18.69, I2=92%). In studies where it was compared to placebo, vernakalant was more effective (RR 7.58 95% CI; 3.75–15.31, I2=58%). However, when vernakalant was compared to an active drug, there was no clear evidence of difference in effect (RR 2.40; 95% CI 0.76–7.58, I2=94). Overall, we judged the quality of evidence for efficacy to be low based on inconsistency and suspected publication bias. There was no evidence of difference in the risk of significant adverse events (e.g. death, heart failure, ventricular arrhythmia) between vernakalant and comparator (RR 0.95 95% CI 0.70–1.28, I2 =0). The quality of this evidence was rated as moderate due to imprecision. Conclusions: Vernakalant is effective in rapidly restoring sinus rhythm in patients with recent onset AF. However, its comparative efficacy versus active agents is less certain.
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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 | 0.003 | 0.012 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.011 | 0.026 |
| Bibliometrics | 0.003 | 0.003 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.008 | 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".