PADIT Trial Summary
The PADIT Trial (Prevention of Arrhythmia Device Infection Trial) was a cluster randomized crossover trial that was designed to assess the efﬁcacy of additional antibiotic measures compared with a single dose of preoperative antibiotics among patients undergoing implantation of a cardiac implantable electronic device (CIED).
The trial was fairly large and included 19,603 patients who required cardiac implantable electronic devices. These patients were randomized to Incremental antibiotics (n = 9,976) [pre-procedural cefazolin plus vancomycin, intraprocedural bacitracin pocket wash, and 2-day post-procedural oral cephalexin] and Conventional treatment (n = 9,627) [pre-procedural cefazolin infusion].
The primary outcome of hospitalization for device infection at 12 months occured in 0.8% patients in incremental group compared to 1.0% patients in conventional treatment group. (OR: 0.77; 95% CI: 0.56 to 1.05; P=0.10)
The authors of PADIT trial concluded that incremental antibiotics strategy was found to be not superior to a single dose of preoperative antibiotics in reducing device infections. Overall infection rates were low, even among patients deemed to be high-risk.
- Incremental antibiotics which include pre, intra and post-procedure antibiotics were found not to be superior to only pre-op antibiotics.
- Overall infection rates were low in high-risk patients ~1%
- Compared to this strategy the antibacterial envelopes for devices were found to be more effective in reducing device infections as noted in the WRAP-IT trial.