Arrhythmias & electrophysiologyRandomised controlled trial
COOPERATIVE-PFA: A Three-Arm Randomized Controlled Trial
- Randomised controlled trial
- three-arm
- 1:1:1 randomisation
Authors' conclusion
In pulsed-field ablation procedures for atrial fibrillation, remimazolam-ketamine DAS was superior to propofol-opioid regimens (either boluses or continuous) and had the lowest risk of hypoxemia and hypotensive events.
Study context
- Population
- Patients undergoing pulsed-field ablation (FARAPULSE) for AF; OSA excluded
- Participants
- 127 patients
- Comparison
- Remimazolam-ketamine deep analgosedation (DAS) and propofol-opioid TIVA vs propofol-opioid DAS
- Pn = 42reference
- Rn = 43
- TIVAn = 42
- Primary endpoint
- Composite of:
- Hypoxemia
- Hypotensive or hypertensive events requiring intervention or leading to procedure discontinuation
Primary result
As reported in the abstract
P < 0.001
- Driven by hypotension in TIVA
- 100%
- R: hypoxemia
- 50%
- R: hypotensive events
- 66.7%
Secondary outcomes
Mean procedural time, patient satisfaction
- No differences observed
Safety
Serious adverse events
- No differences observed in rate of serious adverse events
Original publication
COOPERATIVE-PFA: A Three-Arm Randomized Controlled Trial. Circulation. Published 27 April 2025. doi:10.1161/circulationaha.125.074427
Summarised from the published abstract; every number is checked against it