Key result
Low fixed-dose PCC reduces mean costs ~24% vs variable dosing for emergency VKA reversal.
Why the study?
A well-defined dosing strategy for prothrombin complex concentrates in emergency reversal of vitamin K antagonist-induced coagulopathy is lacking, and cost-effectiveness of a low fixed dose regimen is uncertain.
Does a low fixed dose of prothrombin complex concentrate improve cost effectiveness in bleeding patients on vitamin K antagonist therapy?
Does a low fixed dose of prothrombin complex concentrate improve cost effectiveness in bleeding patients on vitamin K antagonist therapy?
Absolute Event Rate: 4838% vs 6386%
A low fixed dose of prothrombin complex concentrate is suggested to be cost-effective for emergency reversal of vitamin K antagonists.
Fixed-dose PCC may lower reversal costs in VKA-associated bleeding; leaves open outcome equivalence versus variable dosing in prospective trials.
A low fixed dose of prothrombin complex concentrate is cost effective in emergency reversal of vitamin K antagonistsThe management of bleeding patients on vitamin K antagonist (VKA) therapy is a common clinical challenge.Current American College of Chest Physician (ACCP) guidelines recommend the use of prothrombin complex concentrates (PCCs) for rapid reversal of VKA-induced coagulopathy. 1 While efficacy and safety of PCC are well established for VKA reversal, a well-defined dosing strategy is still lacking.Recently, we studied the effectiveness of a low fixed dose regimen of 1040 IU F IX PCC compared to variable dosing to counteract VKA associated emergency bleeding.2 This prospective study showed that low fixed PCC dose was non-inferior to variable dosing in terms of clinical outcome.In reaching the target INR, defined as INR less than 2, the fixed dose was non-inferior in patients with an initial INR below 7.5, but not in patients with a higher INR.An important question from both a clinical and costing point of view is whether additional interventions were needed in the fixed dose cohort to reach the non-inferior outcome.The costs of additional interventions (i.e.other blood products, invasive interventions, or more often admission to an intensive care unit) may nullify any cost savings to be gained from a lower PCC dose.Therefore, we performed a cost analysis, in which we evaluated the direct medical costs in all patients admitted through the emergency room (ER).To prevent bias in estimating the costs of VKA-related bleeds, we excluded patients already hospitalized for other indications.Cost-effectiveness was calculated using 2 decision tree models (Figure 1).In model A, reaching the target INR was modeled while model B was only based on the clinical outcome.Only direct medical costs during hospitalization from ER admission to discharge or death were included.
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Khorsand et al. (2013) studied Vitamin K antagonist-associated emergency bleeding (n=104). Low fixed dose prothrombin complex concentrate (PCC) vs. Variable dosing of PCC was evaluated on Mean costs per successfully treated patient (in euros). A low fixed dose of prothrombin complex concentrate for emergency reversal of vitamin K antagonists reduced mean costs per successfully treated patient compared to a variable dosing strategy (4838 vs 6386 euros).
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