Real-world evidence from the GARFIELD registries provides important insights to aid understanding of the outcomes of anticoagulation
• Data highlighted differences between provoked and unprovoked venous thromboembolism (VTE) patients
• Other topics included the comparative effectiveness of vitamin-K antagonists (VKAs) and direct oral anticoagulants (DOACs) in VTE and atrial fibrillation (AF), cancer-associated thrombosis and regional differences in VTE
Melbourne, Australia, 8th July 2019 – The depth and breadth of real-world evidence available from the Global Anticoagulant Registry in the FIELD (GARFIELD) studies was evident as the Thrombosis Research Institute (TRI) unveiled its latest results during a supported Satellite Symposium at the International Society on Thrombosis and Haemostasis Congress 2019, on Saturday 6th July.
The Symposium, entitled “Understanding the Outcomes of Anticoagulation: Insights from the GARFIELD Registries”, featured a distinguished speaker panel of clinical leaders who shared insights on a wide range of topics pertinent to modern thrombosis management. Topics included perspectives on provoked versus unprovoked VTE; comparative effectiveness in both AF and VTE, cancer-associated thrombosis (CAT) in everyday practice; and regional differences in VTE.
Rt Hon Professor the Lord Ajay K. Kakkar, Director of the Thrombosis Research Institute, UK, said: “Our analysis of the real-world evidence collected in the GARFIELD registries enable us to show physicians how the treatment decisions made during everyday practice around the world are impacting patients’ outcomes. The scale of our registries and the methodological rigour we apply mean that these data can be trusted to help inform and enhance understanding and influence treatment guidance across the globe.”
Examining the differences between provoked and unprovoked VTE, Professor Walter Ageno (Varese, Italy) said that VTE patients with transient provoking risk factors were more likely to be younger, and female, than patients with unprovoked VTE. Furthermore, anticoagulant treatment at baseline was similar between patients with transient provoking factors and unprovoked VTE. However, on average, patients with an unprovoked VTE remained on anticoagulant treatment longer than those with a provoked VTE. “Event rates were comparable between patients with transient provoking factors and unprovoked VTE. Patients with a persistent provoking factor (i.e. active cancer) had an increased incidence of death and major bleeding,” Professor Ageno commented.
Professor Harry Gibbs (Melbourne, Australia) delved into the topic of comparative effectiveness in AF. He told delegates that patients receiving an oral anticoagulant were at a significantly reduced risk of mortality over 2 years follow-up, compared to patients receiving no OAC, after adjustment for baseline variables. Furthermore, patients receiving a non-vitamin K antagonist oral anticoagulant (NOAC) were at a reduced risk of death compared to those receiving a vitamin K antagonist (VKA). Patients on oral anticoagulant (OACs) versus those on no anticoagulants also had a significantly lower risk of stroke/systemic embolism but a higher risk of major bleeding over the 2 years of follow-up. “These observations suggest that the effectiveness of OACs in randomised clinical trials can be translated to the broad cross-section of patients treated everyday practice.” Professor Gibbs concluded.
Professor Alexander G. Turpie (Hamilton, Canada), speaking on comparative effective from a VTE perspective, highlighted that patients receiving NOACs had a significantly reduced chance of all-cause mortality over 12-months follow up. He added that recurrent VTE and major bleeding was not significantly different between the treatment groups. “Our future work will focus on assessing the impact of treatment adherence and duration on outcomes” he revealed. GARFIELD-VTE highlights differences in the treatment patterns of VTE in patients with active cancer, history of cancer or no cancer. Speaking about CAT in everyday practice, Professor Jeff Weitz (Hamilton, Canada) said that rates of death, recurrent VTE and major bleeding were higher in active cancer patients than in those without cancer. He told delegates that the majority of deaths were cancer-related; VTE was the second leading cause of death in both active cancer and history of cancer patients.
Professor Barry Jacobson (Johannesburg, South Africa) presented several differences in baseline characteristics between Europe, Asia, North America and Australia, Latin America, and South Africa and the Middle East, such as the ratio of males to females, the site of VTE, as well as age, BMI and ethnicity. He said that future studies will investigate how these differences may influence clinical outcomes in patients.
GARFIELD-VTE is a prospective, multicentre, observational study of patients with acute VTE. The registry has enrolled more than 10,000 patients with deep vein thrombosis and/or pulmonary embolism from 415 sites in 28 countries. The aim of this global registry is to follow patients for at least three years and to observe patients’ management according to local practices, recording clinical, patient-reported and economic outcomes.