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Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care

Slide: 32 of 36

Overview of rFVIIa Use for Prostatectomy

The usual care of patients who require prostatectomy has changed considerably over the time period encompassing and since the performance of studies included in this analysis. These changes in practice likely account for the negligible use of rFVIIa noted in the Premier database. There were no deaths in either study group. One patient in the group that received the 20 µg/kg dose experienced a myocardial infarction at day 14, the only thromboembolic event identified in the study. The RBC transfusion requirements were significantly reduced in the rFVIIa group, as was the operating room time.

Overall applicability of the evidence is poor for prophylactic use in the populations targeted—patients undergoing retropubic prostatectomy for prostate cancer or benign hyperplasia but who are not on anticoagulation. In addition, the “usual care” approach to prostatectomy has evolved into something very different, in most cases, from the surgeries evaluated in the included RCT, thereby making the applicability of the comparator also poor. Current evidence is insufficient for comparing the harms and benefits of rFVIIa use in prostatectomy. In addition, the usual care for prostatectomy has likely evolved far beyond the standard of care employed in the RCT, making its relevance to current practice uncertain.