Results of a One-Year Registry of Bleeding Complications of Vitamin K Antagonist Therapy outside of a Controlled Population.

Background: The registry was designed to collect data on bleeding complications in patients under Vitamin-K-antagonist therapy (VKA) during a one year period in a predefined area outside a controlled population and to describe clinical management of these complications.

Patients and methods: Between 1.1.05 and 31.12.05, bleeding complications requiring hospital stay in 23 hospitals in eastern saxonia, Germany, were documented. Indication for VKA therapy, type of bleeding, INR at hospital entry, application of packed erythrocytes and fresh-frozen plasma, clinical management and outcome at the end of hospital stay and after 3 months were recorded.

Results: 311 episodes of VKA-associated bleeding were documented. Patients were male in 49%, mean age was 73±10 years. Indication for VKA therapy was atrial fibrillation in 64%, mechanical heart valves in 10%, impaired LV-function in 1%, secondary prophylaxis of VTE in 18% and others in 6%. Bleeding affected the gastrointestinum in 23%, 22% were superficial hematomas, 14% were intracranial, 10% epistaxis, 10% hematuria, 7% intraabdominal/retroperitoneal, 5% were overdoses without clinical signs, 10% involved other sites.

INR on admission was 3.76±2.45, 40% of INR values were above, and 30% were in the targeted INR range. Vitamin K was administered orally in 26% of episodes, FFP in 9%, factor concentrate in 6%. Per episode, 3±2 units of packed erythrocytes were necessary. 8% of patients died during hospital stay. Surgical therapy was chosen in 25% of episodes, 20% were controlled by endoscopy. 3% of episodes were followed by ongoing detoriation of health status. Mean hospital stay was 13±9 days. Mortality was highest in patients with intracranial bleeding (24%). Retroperitoneal/intraabdominal bleedings required the largest amount of blood products and stabilization of coagulation. Three months after the index episode, mortality was 14%.

Conclusions: Complications of VKA-therapy outside of a controlled population occur most often at a supratherapeutic INR level. Gastrointestinal bleeding constitutes the major part of the complications, intra-hospital mortality of 8% is mainly caused by intracranial bleeding.