Arrhythmias & electrophysiology
Efficacy and Safety of Botulinum Toxin Type A for the Prevention of Postoperative Atrial Fibrillation
Authors' conclusion
There were no significant differences in the rate of POAF with either dose compared with placebo; however, there was a lower rate of POAF in participants ≥65 years undergoing CABG only and receiving 125 U of AGN-151607.
Study context
- Population
- Patients undergoing cardiac surgery (coronary artery bypass graft (CABG) and/or valve surgery)modified ITT
- Participants
- 312 patients
- Comparison
- AGN-151607 125 U or 250 U vs placebo
- Placebon = 102reference
- 125 Un = 104
- 250 Un = 106
- Primary endpoint
- Occurrence of continuous AF ≥30 seconds
Methodological detailsphase 2, placebo-controlled, stratified by age and type of surgery
- Phase 2
- Placebo-controlled
- Stratified by age and type of surgery
Primary result
As reported in the abstract
Continuous AF ≥30 seconds
Each group vs placeboRelative risk (95% CI)P value
125 U
0.80(0.58–1.10)
P = 0.16250 U
1.04(0.79–1.37)
P = 0.78Further findings
| Outcome | RR (95% CI) | P value | |
|---|---|---|---|
| Primary endpoint, age ≥65 years (subgroup)125 Uvs Placebo | 0.64 (0.43–0.94) | P = 0.02 | |
| Primary endpoint, CABG only and age ≥65 years (subgroup)125 Uvs Placebo | 0.49 (0.27–0.87) | P = 0.01 | |
| 0.20.5125Relative risk (log scale) |
Rehospitalization
- Similar across the 3 groups
Safety
Adverse events
- Rates similar across the 3 groups
Original publication
Efficacy and Safety of Botulinum Toxin Type A for the Prevention of Postoperative Atrial Fibrillation. JACC Clin Electrophysiol. Published 24 April 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →