Impact of Cipepofol versus Propofol on Long-Term Cardiovascular Outcomes After TAVR: An Extended Follow-Up of a Randomized Trial.

BACKGROUND

Patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) under general anesthesia are particularly vulnerable to hemodynamic instability. General anesthesia remains a common approach and is necessary in selected patients, although conscious sedation is increasingly used. A previous randomized trial showed greater peri-induction hemodynamic stability with cipepofol than with propofol, but whether this translates into improved clinical outcomes is uncertain.

METHODS

We conducted a post hoc, exploratory extended follow-up of a single-center randomized trial. Patients were randomly assigned to cipepofol or propofol. In-hospital analyses included 122 TAVR-treated participants (61 per group), whereas the 30-day and 1-year analyses included 118 participants with follow-up data in the full analysis set (59 per group). The primary endpoint was the 1-year composite of all-cause mortality, stroke, acute kidney injury, myocardial infarction, and new-onset atrial fibrillation (NOAF). For this exploratory analysis, the components were grouped based on their hypothesized association with periprocedural hemodynamic instability and were also reported separately.

RESULTS

At 1 year, the primary composite endpoint occurred in 13/59 (22.0%) patients in the cipepofol group and 22/59 (37.3%) patients in the propofol group (hazard ratio [HR] 0.56; 95% confidence interval [CI] 0.28 to 1.10; P = 0.093). NOAF, analyzed separately as an exploratory secondary endpoint, occurred less frequently with cipepofol than with propofol (7/59 [11.9%] vs 17/59 [28.8%]; HR 0.39; 95% CI 0.16 to 0.95; P = 0.037). At 30 days, the composite endpoint occurred in 9/59 (15.3%) and 14/59 (23.7%) patients, respectively (HR 0.63; 95% CI 0.27 to 1.45; P = 0.277). The in-hospital composite endpoints were 10/61 (16.4%) and 16/61 (26.2%), respectively (P = 0.185).

CONCLUSION

In this exploratory extended follow-up, cipepofol did not significantly reduce the 1-year primary composite endpoint compared with propofol. The observed lower incidence of NOAF should be regarded as hypothesis-generating given the limited sample size, multiple comparisons, and intermittent rhythm surveillance. The applicability of these findings is limited to patients undergoing transfemoral TAVR under general anesthesia and does not extend to procedures performed under conscious sedation.