Hospitalization for vitamin-K-antagonist-related bleeding: treatment patterns and outcome

Abstract

Summary. Background: Bleeding complications are common side effects of vitamin-K antagonist (VKA) therapy. Data on the in-hospital management and outcomes of these bleeding events are scarce and information is mostly derived from trial cohorts. Objectives: The objective was to collect data on the management and clinical outcome of hospitalizations owing to VKA-related bleeding in real-world practice. Patients and methods: We performed a multicenter observational cohort study involving 21 secondary and tertiary care hospitals in the administrative district Dresden, Saxony, Germany throughout the year 2005. All consenting patients presenting with VKArelated bleeding complications were included. No exclusion criteria applied. Data were collected at admission, at discharge and at 90 days to evaluate resource consumption, length of hospital stay and risk factors for in-hospital-and 3-month mortality. Results: Two hundred and ninety patients were included (median age 74 years; 50.7% male). The main indications for VKA therapy were atrial fibrillation (63.4%), prior thromboembolism (18.6%) and mechanical heart valves (11.4%), and most common bleeding localizations were large hematoma (23.1%), upper gastrointestinal (GI) tract (17.9%) and intracranial bleeding (14.1%). On hospital admission, the median International Normalized Ratio (INR) was 3.0 (range 0.9-12.5, interquartile range [IQR] 2.1-3.9). Inhospital mortality was 7.6% with impaired renal function as the most relevant risk factor. At 90 days mortality was 14.1% and 15.3% of survivors were help-dependent. Conclusions: VKA-related bleeding leading to hospitalization is associated with long hospitalization, relevant resource utilization, high mortality or persistent sequlae. Patientrelated factors such as impaired renal function, chronic cardiac or pulmonary disease and dementia are predictive of in-hospital and 3-month mortality.

Rates, management, and outcome of rivaroxaban bleeding in daily care: results from the Dresden NOAC registry

“…Furthermore, for comparison with available data for VKA-related major bleeding (often defined as bleeding leading to hospitalization), 7,9 the case fatality rate (all-cause mortality) of all rivaroxaban bleeding events leading to hospitalization was evaluated.…”

“…Recent data from large cohorts of daily care VKA patients indicate that the case fatality rate of VKA-related major bleeding is approximately 15% to 20% [7][8][9] and up to 50% for intracranial bleeding, 21 despite the fact that decades of experience and specific and nonspecific reversal agents, such as vitamin K or prothrombin complex factor concentrates, are available to treat VKA-related bleeding events. 22 The lack of experience, specific reversal agents, or coagulation tests to measure the anticoagulant activity of novel anticoagulants in emergency situations has led to considerable concern regarding the outcome of major bleeding complications during rivaroxaban therapy.…”

“…[3][4][5][6][7][8] Furthermore, in cases of major bleeding or bleeding requiring hospitalization during VKA therapy, case fatality rates were shown to be as high as 13% to 18%. [7][8][9] The non-VKA oral anticoagulant (NOAC) rivaroxaban is a selective inhibitor of the activated coagulation factor X (factor Xa). It has an excellent dose-response relationship, few drug-drug interactions, and no drug-food interactions.…”

Hospitalizacijų Ir Gydymo Analizė Įvykus Vitamino K Antagonistų Perdozavimui

“…Šiame tyrime taip pat nustatytas ženkliai didesnis gydymo komponentų sunaudojimas kraujavusiems pacientams, mažiau skiriantis tik vitamino K injekcijų sunaudojimui. Šis rezultatas atkartojo kitose studijose gautus rezultatus, kur didesnis gydymo komponentų sunaudojimas lėmė ženkliai didesnes išlaidas gydant pacientus [18,19,21,22]. Mažesnį vitamino K sunaudojimo skirtumą tarp kraujavusiųjų ir nekraujavusių galima paaiškinti tuo, jog vitaminas K paprastai skiriamas profilaktiškai, kai yra viršijamas INR terapinis indeksas, nepaisant to, ar yra kraujavimas, tuo tarpu kiti gydymo komponentai skiriami tik pasireiškus agresyvesniems kraujavimo reiškiniams, todėl jų sunaudojimas mažesnis, o skirtumas tarp grupių didesnis.…”

Reversing targeted oral anticoagulants

“…Recent data from large cohorts of patients on VKA estimate the fatality rate of VKA-related major bleeding at ϳ15%-20%, up to 50% for intracranial bleeding. 22,23 Although there was no direct comparison with patients treated with VKA, it appears that rates of rivaroxaban-related major bleeding may be lower and outcomes are not worse than in VKA-treated patients. In summary, only small numbers of patients with rivaroxaban-associated bleeding required a reversal strategy, with prohemostatic therapy being given only in life-threatening situations.…”