Study endpoints and sample size calculation
AKI, stroke, TAVI, periprocedural myocardial injury
STROKE, PULMONARY COMPLICATIONS, CONDUCTION ABNORMALITIES
The primary study outcome was periprocedural myocardial injury, as reflected by the geometric area under the curve (AUC) for periprocedural serum hs-cTnI in the first 72 h post-TAVI, calculated according to the trapezoidal rule. Secondary outcomes were the AUC for serum CK-MB in the first 72 h post-TAVI, and the peak serum hs-cTnI and CK-MB levels in the same period. Post-procedural clinical outcomes were also evaluated, including AKI, AKR, new conduction abnormalities, permanent pacemaker insertion, stroke, MI, pulmonary complications, in-hospital cardiovascular mortality, and hospital length of stay.To calculate the sample size, we conducted a pilot study of 10 patients undergoing transfemoral TAVI under general anesthesia. The AUC for serum hs-cTnI in the first 72 h after TAVI was 40.24 ± 28.16 ng/mL. To detect a 50% difference in hs-cTnI levels between the two treatment groups in the first 72 h, which was chosen to be clinically relevant by the study investigators, 32 patients were required for each group at 80% power and an alpha error of 5% when compared using an independent 