Trial of Vancomycin and Cefazolin as Surgical Prophylaxis in Arthroplasty

Peel, TN; Astbury, S; Cheng, AC; Paterson, DL; Buising, KL; Spelman, T; Tran-Duy, A; Adie, S; Boyce, G; McDougall, C; Molnar, R; Mulford, J; Rehfisch, P; Solomon, M; Crawford, R; Harris-Brown, T; Roney, J; Wisniewski, J; de Steiger, R; ASAP Trial Group

doi:10.1056/nejmoa2301401

Sepsis & infection

Trial of Vancomycin and Cefazolin as Surgical Prophylaxis in Arthroplasty

N Engl J MedPublished 19 Oct 2023Randomised controlled trial

Primary resultResultRelative risk 1.28 95% CI 0.94–1.73

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Authors' conclusion

The addition of vancomycin to cefazolin prophylaxis was not superior to placebo for the prevention of surgical-site infections in arthroplasty among patients without known MRSA colonization.

Study context

Population: Adults without known methicillin-resistant Staphylococcus aureus (MRSA) colonization undergoing arthroplasty4,113 in modified ITT population
Participants: 4,239 adults

Comparison: Vancomycin vs Placebo
Vancomycinn = 2,044
Placebon = 2,069reference
Primary endpoint: Surgical-site infection
Follow-up: Within 90 days after surgery

Methodological detailsmulticentre, double-blind, superiority, placebo-controlled

Multicentre
Double-blind
Superiority
Placebo-controlled

Primary result

As reported in the abstract

Relative risk

1.28

95% CI 0.94–1.73

P = 0.11

Events by treatment group

Vancomycin4.5%91 of 2044

Placebo3.5%72 of 2069

Vancomycin vs Placebo

RR 1.28 (95% CI 0.94–1.73); P = 0.11

Further findings

Outcome	Vancomycin	Placebo	← Lower risk with vancomycin ←→ Higher risk with vancomycin →	RR (95% CI)
Surgical-site infection (subgroup: knee arthroplasty)	5.7%	3.7%	0.512	1.52 (1.04–2.23)
Surgical-site infection (subgroup: hip arthroplasty)	3.0%	3.1%	0.512	0.98 (0.59–1.63)
			0.512Relative risk (log scale)

Surgical-site infection (subgroup: knee arthroplasty): Vancomycin n = 1109, Placebo n = 1124
Surgical-site infection (subgroup: hip arthroplasty): Vancomycin n = 920, Placebo n = 930

Safety

Adverse events

Vancomycin1.7%

Placebo1.7%

Outcome	Vancomycin	Placebo	← Lower risk with vancomycin ←→ Higher risk with vancomycin →	RR (95% CI)
Hypersensitivity reactions	1.2%	0.5%	0.20.5125	2.20 (1.08–4.49)
AKI	2.1%	3.6%	0.20.5125	0.57 (0.39–0.83)
			0.20.5125Relative risk (log scale)

Adverse events: Vancomycin n = 2010, Placebo n = 2030

Original publication

Trial of Vancomycin and Cefazolin as Surgical Prophylaxis in Arthroplasty. N Engl J Med. Published 19 October 2023. doi:10.1056/nejmoa2301401

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