The first results from the GARFIELD-VTE (Global anticoagulant registry in the field—venous thromboembolism) were presented at the International Society on Thrombosis and Haemostasis Congress 2017 (8–13 July, Berlin, Germany) providing a contemporary picture of VTE management worldwide.
GARFIELD-VTE is a prospective, multicentre, observational study of patients requiring treatment for acute VTE. The registry enrolled more than 10,000 patients with acute VTE (deep vein thrombosis [DVT] and pulmonary embolism [PE]) from across 415 sites in 28 countries between May 2014 and January 2017. Study sites reflect the diversity of care settings in each country, including hospital, outpatient and community settings, making this study uniquely placed to provide data on several subsets of VTE patients, including those with recurrent VTE, post-thrombotic syndrome and chronic thromboembolic pulmonary hypertension.
The aim of this global registry is to follow patients for at least three years and to observe patients management according to local practices and to record clinical, patient-reported and economic outcomes. The first data from GARFIELD-VTE offer fresh insights into the clinical characteristics, treatment patterns and outcomes of VTE patients, including those with cancer.
“For patients with DVT and PE, fast action in the acute phase of treatment, especially rapidly fatal PEs, is vital for preserving life and health. As a global registry collecting long-term data from diverse countries, care settings and patients, GARFIELD-VTE is able to provide unprecedented insights on managing and improvement patient care,” said Ajay K Kakkar, professor of surgery at University College London and director of the Thrombosis Research Institute, UK.
Clinical characteristics and management
In an oral presentation Walter Ageno, associate professor of medicine at the University of Insubria and director of the Short-Stay Medical Unit and Thrombosis Center at the Ospedale di Circolo of Varese, Italy, presented data on the clinical characteristics and management of 10,677 patients with a confirmed diagnosis of DVT and/or PE enrolled in GARFIELD-VTE. Surgery (12.5%) and hospitalisation (12%) were the main provoking risk factors. The analysis demonstrated that treatment patterns are rapidly evolving. The direct oral anticoagulants (DOACs) were prescribed to approximately half of the patient population, in similar proportions between DVT and PE, and PE patients were more likely to receive initial parenteral treatment with low molecular weight heparin (LMWH).
Data seen during a poster session led by Jeff Weitz, professor of medicine and biochemistry and biomedical sciences at McMaster University, Hamilton, Ontario, Canada, highlighted the differences in the treatment patterns of VTE in patients with active cancer compared to those with a history of cancer or no cancer. The most common site of cancer-associated thrombosis are lung (in men) and gynaecological (in women). Patients with active cancer (56.1%) were more likely to receive LMWH as initial therapy than those with a history of cancer (15.9%) or no cancer (9.2%). DOACs with or without LMWH were prescribed in almost 27% of patients.
Sylvia Haas, emeritus professor of medicine of the Haemostasis and Thrombosis Research Group, Technical University of Munich, Munich, Germany, spoke about anticoagulant treatment patterns for VTE. She said that the variation of initial AC treatment patterns during enrolment of patients is less than originally expected because momentum in DOACs prescribing had already taken hold when GARFIELD-VTE started. Where variations are seen, said Haas, these are based not only on patient population and site of VTE but also by geographic region, and may reflect cultural differences as well as registration and reimbursement of DOACs. There was a clear shift from conventional parenteral plus VKA treatment in the first 30 days towards DOACs in the following five months, raising the question about whether DOACs have become the new standard of care for chronic anticoagulation.
Presenting the Registry’s first six-month outcomes data, Alexander GG Turpie, professor emeritus, McMaster University, Hamilton, Ontario, Canada, reported that rates of all-cause mortality, first occurrence of major bleeding and VTE recurrence were: 9.7 (8.8–10.6), 2.2 (1.9–2.7), and 3.6 (3.1–4.2) per 100 person-years, respectively. Overall, 106 of 622 (17%) bleeds were major, requiring transfusion in 90 (14.5%) cases. Fatal bleeding occurred in 15 of 622 (2.4%) patients with any bleeding event. One hundred and ninety-five new cases of cancer were detected over six months which is equivalent to a rate of 4.1 per 100 person-years. Death was the most frequent major adverse outcome in patients with VTE, half of which were cancer-related.
The next set of GARFIELD-VTE data will be presented at the American Society of Hematology Congress (9–12 December, Atlanta, USA).