Clinical outcome of patients with a vitamin K antagonist‐associated bleeding treated with prothrombin complex concentrate

ESSENTIALS: Data on clinical outcome of vitamin K antagonist (VKA)‐associated bleeding is scarce. Cohort study of patients with VKA bleeds treated with prothrombin complex concentrate (PCC). Effective haemostasis was achieved in 68% of patients with a VKA‐associated bleeding. Thromboembolism rates were low and mortality rates high at 30 days after PCC administration. BACKGROUND: Vitamin K antagonists (VKA) are used for the treatment of thromboembolism. Patients with severe VKA‐associated bleeding require immediate restoration of haemostasis. Clinical studies on the effect of prothrombin complex concentrate (PCC) are heterogeneous with respect to outcome of bleeding. OBJECTIVE: To evaluate the clinical outcome of patients treated with PCC for VKA‐associated bleeding. METHODS: We performed a cohort study of consecutive patients who received PCC for VKA‐related bleeding in five Dutch hospitals. Data were collected by chart review on the bleeding event, international normalized ratio (INR), haemostatic efficacy, thromboembolic (TE) complications, and mortality. The primary outcome was effective haemostasis, assessed by an adaptation of the Sarode criteria with a surrogate outcome for patients with ICH without repeat CT. RESULTS: One hundred patients were included. Mean age was 74 years, 54% were male and 79% received VKA for atrial fibrillation. Most patients presented with ICH (41%) or GI bleeding (36%). Effective haemostasis was achieved in 67/98 (68%) patients using the adapted classification. Surrogate outcomes were applied for 32 patients and data for two patients was missing. Median pre‐treatment INR was 3.9 (IQR 2.9‐5.8). One hour after PCC infusion, the INR was available for 50 patients and of these, 35 (70%) had an INR ≤1.4. TE complications occurred in five patients and 22 died (60% bleeding‐related) within 30 days. CONCLUSION: PCC achieved effective haemostasis in 68% of evaluable patients with VKA‐associated bleeding. TE complication rates were low, but mortality rates were high, due to the large number of patients with ICH.