We included eligible studies from the most recent systematic review for patients presenting with VKA-associated bleeding who received PCC vs FFP in addition to vitamin K and temporary cessation of VKA.182 The search was updated from 2016 onward, yielding 3 eligible RCTs.183-185 Additional studies included in the systematic review proved ineligible because patients needed VKA reversal for urgent or semiurgent surgery and not because of bleeding. Three studies reported the effect of PCC vs FFP on mortality,183-185 2 studies reported on development of any thromboembolism and 1 study reported the outcomes of PE and 2 studies reported on volume overload (this outcome was not originally prioritized but was felt by the panel to be an important outcome for consideration),183,184 and 2 studies reported on the proportion of patients who reached the INR goal of ,1.3185 or (follow-up ranged from 0.5 to 3 hours). The EtD framework is shown online at https://dbep.gradepro.org/profile/e58f8d6b- 8fd6-4164-b9da-2c62605e845c. Benefits. For benefits, see the evidence profile in the EtD framework referenced at the end of the previous section, available online. Studies assessing mortality reported no difference between those receiving 4-factor PCC and FFP (RR, 0.92 [95% CI, 0.37- more per 1000]; very low certainty). Four-factor PCC reduced the incidence of volume overload (RR, 0.34 [95% CI, 0.13-0.85]; ARR, 107 fewer episodes per 1000 [95% CI, 24 fewer to 141 fewer per 1000]; low certainty) and increased the proportion of patients who reached an INR of #1.2 to 1.3 within 0.5 to 3 hours (RR, 6.66 [95% CI, 3.82-11.61]; moderate certainty). Harms and burden. 