In Reply We are happy that our article published in JAMA Surgery, “Effect of Prophylactic Embolization on Patients With Blunt Trauma at High Risk of Splenectomy: A Randomized Clinical Trial,”1 has stimulated discussion on the feasibility and benefits, or not, of prophylactic splenic artery embolization.
We agree with Windle et al that the anticipated splenic salvage rate of 60% was underestimated. They queried our relatively small sample size, the blinding measures, exclusion of some patients from the analysis, our main outcome that included 50% vascularization, and use of the term prospective. Considerations restricting trial size included the difficulties of performing randomized clinical trials in an emergency setting and ensuring homogeneity in practices, equipment, and investigator experience, causing us to restrict study participation to expert centers. Moreover, we rejected a prolonged patient inclusion period as practices evolve over time. The limitations in study size prevented an economic analysis and did not permit a statistically meaningful analysis comparing the effect of admission time. Radiologists were blinded to the randomization arm; we agree that they would have been able to detect a stent in the 1-month image, but they did not know when it had been implanted immediately or during follow-up. We considered full clinical blinding to be unethical. The only patients excluded were those who should not have been included in the first place. Our outcome including 50% vascularization is in line with current practice recommendations, as discussed.2 In clinical research, prospective studies, in which only patient inclusion, interventions, and events taking place after study protocol approval are considered, carry far greater weight of evidence than retrospective studies.
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Arvieux C, Ghelfi J, Foote A. Blunt Splenic Injury and Prophylactic Splenic Artery Embolization—Reply. JAMA Surg. 2021;156(7):693. doi:10.1001/jamasurg.2021.0640
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