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• W3147165368 abstract "We read with great interest the letter by David Buis regarding the interpretation of the results of our study reporting outcomes of cefazolin versus anti-staphylococcal penicillins in methicillin-susceptible Staphylococcus aureus (MSSA) infective endocarditis [[1]Buis D. Re: ‘Comparative outcomes of cefazolin versus Anti-Staphylococcal penicillins in methicillin-susceptible Staphylococcus aureus infective endocarditis: a post-hoc analysis multicentre French cohort study’ by Lecomte et al.Clin Microbiol Infect. 2021; (S1198743X21000549. Online ahead of print.)https://doi.org/10.1016/j.cmi.2021.01.027Abstract Full Text Full Text PDF PubMed Scopus (1) Google Scholar]. In this letter, the lack of power of our study as well as the use of a superiority test to compare the two treatments are questioned and bring Buis to the conclusion that an equivalence between the two treatments cannot be established. Indeed, we have to admit that an absence of proof of effect is not the proof of absence of effect. Therefore, in our paper, our conclusion was cautious in the sense that we did not observe a difference in efficacy between the two treatments. We also pointed out that additional randomized interventional studies were needed to assess which anti-staphylococcal β-lactam should be considered as a first-line antibiotic. As suggested by Buis, the next logical step of our approach would be a non-inferiority study. A non-inferiority study supposes the definition of a margin of non-inferiority (Δ), which can correspond to an acceptable loss of effectiveness that is allowed for considering the non-inferiority of cefazolin. Dealing with death as the main outcome, it is difficult, if not impossible, to define an acceptable percentage of excess mortality. We will have to set a very low Δ, which implies the inclusion of a large number of patients. Now, let us assume that the results we found in our study are correct, with an advantage for cefazolin compared with anti-staphylococcal penicillins for 90-day mortality: 24.5% versus 28.7%, respectively. Then, with an acceptable absolute Δ of 1.5% (i.e. a relative increase mortality of roughly 5%), an α risk set to 5%, a power of 80%, and the favourable hypothesis of well-balanced groups (1:1), a total of 1484 patients (742 per group) would be needed to reach a statistical power of 80% (statistical analyses performed with EpiR package, ‘tools for the analysis of epidemiological and surveillance data’, version 20.0.19). For the record, assuming the unfavourable but likely hypothesis of a same 90-day mortality in both groups, of 30%, the needed population size would reach 23 082 patients (11 541 per group). With a more sophisticated design, a randomized controlled trial with paired–matched patients could allow these values to be reduced. Such a study would be of great interest but endocarditis is a rare disease [[2]Habib G. Lancellotti P. Antunes M.J. Bongiorni M.G. Casalta J.-P. Del Zotti F. et al.2015 ESC guidelines for the management of infective endocarditis: the task force for the management of infective endocarditis of the European Society of Cardiology (ESC). Endorsed by: European Association for Cardio-Thoracic Surgery (EACTS), the European Association of Nuclear Medicine (EANM).Eur Heart J. 2015; 36: 3075-3128Crossref PubMed Scopus (2206) Google Scholar,[3]Dayer M.J. Jones S. Prendergast B. Baddour L.M. Lockhart P.B. Thornhill M.H. Incidence of infective endocarditis in England, 2000–13: a secular trend, interrupted time-series analysis.Lancet. 2015; 385: 1219-1228Abstract Full Text Full Text PDF PubMed Scopus (318) Google Scholar] and MSSA endocarditis represents only one-quarter of all cases [[4]Habib G. Erba P.A. Iung B. Donal E. Cosyns B. Laroche C. et al.Clinical presentation, aetiology and outcome of infective endocarditis. Results of the ESC-EORP EURO-ENDO (European infective endocarditis) registry: a prospective cohort study.Eur Heart J. 2019; 40: 3222-3232Crossref PubMed Scopus (131) Google Scholar]. Our study is, to our knowledge, the largest study on the topic and is based on real-life data on cefazoline in infective endocarditis. GRADE approach explicitly allows inclusion of observational research when assessing confidence in the evidence [[5]von Elm E. Altman D.G. Egger M. Pocock S.J. Gøtzsche P.C. Vandenbroucke J.P. et al.The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies.Lancet. 2007; 370: 1453-1457Abstract Full Text Full Text PDF PubMed Scopus (5033) Google Scholar]. Cohort studies improve our understanding of this pathology and its treatment: European guidelines specified that published antibiotic efficacy data from clinical cohort studies in patients with endocarditis have been considered to build recommendations, unlike data from experimental endocarditis models [[2]Habib G. Lancellotti P. Antunes M.J. Bongiorni M.G. Casalta J.-P. Del Zotti F. et al.2015 ESC guidelines for the management of infective endocarditis: the task force for the management of infective endocarditis of the European Society of Cardiology (ESC). Endorsed by: European Association for Cardio-Thoracic Surgery (EACTS), the European Association of Nuclear Medicine (EANM).Eur Heart J. 2015; 36: 3075-3128Crossref PubMed Scopus (2206) Google Scholar]. To conclude, we believe that our study, which followed a multicentre design with a systematic consecutive inclusion of 210 patients, provides useful information about cefazolin for clinicians who manage patients with MSSA endocarditis. Also, this information will help to set the best size for possible future studies, especially if we want to address the issue of non-inferiority. The authors declare no conflicts of interests concerning this article. Re: ‘Comparative outcomes of cefazolin versus anti-staphylococcal penicillins in methicillin-susceptible Staphylococcus aureus infective endocarditis: a post-hoc analysis multicentre French cohort study’ by Lecomte et al.Clinical Microbiology and InfectionVol. 27Issue 8PreviewIn their publication in Clinical Microbiology and Infection, Lecomte et al. evaluate the effect of cefazolin versus anti-staphylococcal penicillins (ASPs) in infective endocarditis caused by methicillin-susceptible Staphylococcus aureus (MSSA) [1]. This research question is highly relevant, since current management of MSSA endocarditis is mostly guided by evidence of poor quality [2]. Furthermore, in vitro studies indicate that high-inoculum infections such as endocarditis might be associated with an increase in cefazolin MICs for which the clinical relevance remains elusive [3]. Full-Text PDF Comparative outcomes of cefazolin versus antistaphylococcal penicillins in methicillin-susceptible Staphylococcus aureus infective endocarditis: a post hoc analysis of a prospective multicentre French cohort studyClinical Microbiology and InfectionVol. 27Issue 7PreviewCurrent guidelines recommend cefazolin as an alternative to antistaphylococcal penicillins (ASPs) in methicillin-susceptible Staphylococcus aureus (MSSA) infective endocarditis despite the lack of comparative study. The objective of this study was to evaluate the comparative outcomes of cefazolin vs. ASPs in MSSA infective endocarditis. Full-Text PDF" @default.
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• W3147165368 title "‘Comparative outcomes of cefazolin versus anti-staphylococcal penicillins in methicillin-susceptible Staphylococcus aureus infective endocarditis: a post-hoc analysis multicentre French cohort study’—author's reply" @default.
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