Acronym: Prevention of Arrhythmia Device Infection Trial

Purpose: Comparison of conventional antibiotic therapy vs. aggressive antibiotic therapy for the prevention of arrhythmia device infection in high-risk patients undergoing arrhythmia device procedures

Format: Cluster-randomized, parallel-assignment, open-label

Treatment Group: Aggressive antibiotic therapy plan of a single preoperative dose of IV cefazolin and vancomycin, an intraoperative bacitracin pocket wash and oral cephalosporin for 2 days after cardiac device surgery

Control Group: Conventional antibiotic therapy plan of IV cefazolin only

Number of Participants: 19,603

Centers: 28

Inclusion Criteria:

  • High-risk patients, defined as those who had a repeat procedure in the arrhythmia device pocket such as a generator change, a lead or pocket procedure or an update, or those implanted with a cardiac resynchronization therapy device
  • Six centers also included low-risk patients, defined as those who had a pacemaker or implantable cardioverter defibrillator implanted for the first time

Primary Outcome(s): Hospitalization attributed to device infection

Summary: The primary outcome of hospitalization for device infection at 1 year was modestly lower in the incremental antibiotic strategy group vs. the conventional strategy group (0.78% vs. 1.03%; OR = 0.77; 95% CI, 0.56-1.05). The overall rate of infection was approximately 1% lower than the expected 2%. Adverse events were low and similar between the groups aside from allergic reactions, which were higher in the incremental group (0.2% vs. 0.5%; P - .018).

Link to Cardiology Today Article: