Worldwide Randomized Antibiotic Envelope Infection Prevention Trial - WRAP-IT

May 16, 2019
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Medtronic
Date Presented:
03/17/2019
Date Published:
05/16/2019
Date Updated:
05/16/2019
Original Posted Date:
03/17/2019
References

Contribution To Literature:

The WRAP-IT trial showed that an antibiotic-eluting envelope was superior to control at preventing device infections. 

Description:

The goal of the trial was to evaluate an absorbable antibiotic-eluting envelope compared with control among patients undergoing placement of a cardiac implantable electronic device. The envelope elutes antibiotics over a minimum of 7 days and the envelope is absorbed in approximately 9 weeks.


Study Design

  • Randomized
  • Parallel
  • Stratification

Patients undergoing placement of a cardiac implantable electronic device were randomized to an absorbable antibiotic-eluting envelope (n = 3,495) versus control (n = 3,488). All patients received preprocedure intravenous antibiotics and sterile technique.

  • Total number of enrollees: 6,983
  • Duration of follow-up: 20.7 months
  • Mean patient age: 70.1 years
  • Percentage female: 28.3%

Inclusion criteria:

  • Placement of a cardiac implantable electronic device pocket revision, generator placement, or system upgrade or an initial implantation of a cardiac resynchronization therapy defibrillator

Principal Findings:

The primary outcome, infection resulting in system extraction or revision, long-term antibiotic therapy with infection recurrence, or death within 12 months, occurred in 0.7% of the antibiotic envelope group compared with 1.2% of control group (p = 0.04).

The secondary outcome, procedure-related or system-related complication within 12 months, was 6.0% with antibiotic envelope versus 6.9% with control (p for noninferiority < 0.001).

Interpretation:

Among patients undergoing placement of a cardiac implantable electronic device, an absorbable antibiotic-eluting envelope was superior to control at preventing system extraction or revision, long-term antibiotic therapy with infection recurrence, or death within 12 months. Procedure-related or system-related complications were similar between treatment groups. Cardiac implantable electronic device infections are uncommon but result in significant morbidity and mortality. This strategy reduced infectious complications in addition to standard preprocedure intravenous antibiotics and sterile technique.

References:

Tarakji KG, Mittal S, Kennergren C, et al., on behalf of the WRAP-IT Investigators. Antibacterial Envelope to Prevent Cardiac Implantable Device Infection. N Engl J Med 2019;380:1895-1905.

Editorial: Perez F, Bonomo RA. Cardiac Devices Enveloped With an Ounce of Prevention. N Engl J Med 2019;380:1965-6.

Presented by Dr. Khaldoun G. Tarakji at the American College of Cardiology Annual Scientific Session (ACC 2019), New Orleans, LA, March 17, 2019.

Keywords: ACC Annual Scientific Session, ACC19, Anti-Bacterial Agents, Antibiotic Prophylaxis, Arrhythmias, Cardiac, Cardiac Resynchronization Therapy, Defibrillators, Defibrillators, Implantable, Infections, Secondary Prevention


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