COOPERATIVE-PFA (remimazolam/ketamine vs. propofol/opioid)
Trial question
What is the effect of continuous remimazolam/ketamine deep analgosedation in patients indicated for AF catheter ablation?
Study design
Single center
Single blinded
RCT
Population
Characteristics of study participants
35.0% female
65.0% male
N = 85
85 patients (30 female, 55 male).
Inclusion criteria: adult patients indicated for AF catheter ablation.
Key exclusion criteria: obstructive sleep apnea syndrome; HF grade III-IV; significant valvopathy; apnea-hypopnea index ≥ 30.
Interventions
N=43 remimazolam/ketamine DAS (optimized continuous intravenous deep analgosedation based on remimazolam and ketamine).
N=42 propofol/opioid DAS (conventional propofol deep analgosedation).
Primary outcome
Hypoxemia, hypotensive or hypertensive events requiring intervention or leading to procedure discontinuation
27.9%
85.7%
85.7 %
64.3 %
42.9 %
21.4 %
0.0 %
Remimazolam/ketamine
DAS
Propofol/opioid
DAS
Significant
decrease ▼
NNT = 1
Significant decrease in hypoxemia, hypotensive or hypertensive events requiring intervention or leading to procedure discontinuation (27.9% vs. 85.7%; RR 0.33, 95% CI 0.13 to 0.53).
Secondary outcomes
Significant decrease in hypoxemia (14% vs. 85.7%; RR 0.16, 95% CI 0.07 to 0.25).
No significant difference in hypotension (18.6% vs. 23.8%; RR 0.78, 95% CI -3.77 to 5.33).
No significant difference in hypertension (2.3% vs. 0%; AD 2.3%, 95% CI -176626.72 to 176631.32).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In adult patients indicated for AF catheter ablation, remimazolam/ketamine DAS was superior to propofol/opioid DAS with respect to hypoxemia, hypotensive or hypertensive events requiring intervention or leading to procedure discontinuation.
Reference
Veronika Sochorová, Veronika Kunštátová, Pavel OsmanČík et al. COnventional vs. Optimized PERiprocedural Analgosedation vs. Total IntraVEnous Anesthesia for Pulsed-Field Ablation: a Three-Arm Randomized Controlled Trial (COOPERATIVE-PFA). Circulation. 2025 Apr 27. Online ahead of print.
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