The Per-procedural Antibiotic Prophylaxis in Patients Undergoing Transcatheter Aortic Valve Implantation Trial

The PAPPI trial is designed as a prospective, crossover, unblinded, cluster randomized trial. The study includes all TAVI centers in Denmark. Each center will be included for either single dose cephalosporin (1st, 2nd or 3rd generation) plus a beta-lactam antibiotic with spectrum for Enterococcus faecalis (e.g. ampicillin 2g) or single dose of a cephalosporin (1st, 2nd or 3rd generation) as antibiotic prophylaxis in relation to TAVI. The antibiotic(s) will be given as a single dose intravenously per-procedural. Patients will be followed from date of TAVI procedure until 6 months post procedure.

The primary outcome of the PAPPI trial will be a composite of the following components within 6 months post TAVI:

* Bacteremia (excluding all enterobacterales) * Death

Secondary outcomes will be each separate component of the primary outcome and will be ana-lyzed separately as time-to-first event analysis. Additional secondary outcomes will be;

* Bacteremia (excluding all enterobacterales) * Acute kidney failure * Death * Length of hospital stay * Days-out-of-hospital from TAVI to 6 months

• Number of patients who died by 6 months [Срок оценки: 6 months post-TAVI]
• Bacteremia assessed by collection of blood cultures. [Срок оценки: 6 months post-TAVI]
• Number of patients with acute kidney failure assessed by plasma creatinine levels. [Срок оценки: 6 months post-TAVI]
• Length of hospital stay [Срок оценки: From the day of TAVI-procedure until the day of discharge after the TAVI-procedure e.g. days from TAVI-procedure until discharge assessed up to 6 months post-TAVI due to end of follow-up.]
• Days-out-of-hospital from TAVI to 6 months [Срок оценки: 6 months post-TAVI]