The rate of adverse events was higher in patients suffering from both deep vein thrombosis and pulmonary embolisms than it was in just patients with DVT.
While edoxaban features a positive risk-benefit ratio when compared to conventional therapy with warfarin in treating venous thromboembolism (VTE), the efficacy and safety of the medication is not yet understood during the highest risk period in this patient population.
A team, led by Giancarlo Agnelli, Internal and Cardiovascular Medicine-Stroke Unit, University of Perugia, assessed the real-world benefits and risks of edoxaban during the first 3 months of treatment, considered the highest risk period for further VTE events.
In the prospective, non-interventional, post-authorization study, dubbed ETNA-VTE Europe, the investigators examined 2672 VTE patients in 8 European countries. Each participant had deep vein thrombosis (DVT, n = 1117) and/or pulmonary embolism (PE, n = 1555) that occurred within 2 weeks of enrollment and received edoxaban therapy.
The mean age of the patient population was 62.9 ± 16.0 years old, while the mean bodyweight was 81.9 ± 17.4 kg, and the mean estimated glomerular filtration rate (eGFR) was 95.4 ± 42.8 mL/min.
Overall, 66.4% of the study participants (PE ± DVT, 68.5%; DVT-only, 64.8%) received heparin lead-in treatment for at least 5 days. The majority of patients (87.7%) received 60 mg of edoxaban once daily.
The adverse event rates at 3 months was 0.34 for recurrent VTE (n = 9), 0.97% for major bleeding (n = 26), and 0.79% for all-cause mortality (n = 21). The rates were higher in patients with both pulmonary embolism and deep vein thrombosis than in a group with just DVT (recurrent VTE; PE ± DVT, 0.45%; n = 5; DVT, 0.26%; n = 4; major bleeding: PE ± DVT, 1.34%; n = 15; DVT, 0.71%; n = 11; all-cause mortality: PE ± DVT. 1.16%; n = 13; DVT, 0.51%; n = 8).
“The results support the safety and effectiveness of edoxaban in a general VTE population during the most critical time period, the first 3 months,” the authors wrote. “The outcomes of this study extend the principal efficacy and safety data on edoxaban into the routine clinical practice setting.”
Recently, the European Society of Cardiology (ESC) released new guidelines for the management of acute pulmonary embolism with the help of 44 national cardiac societies.
The organizations recommended stratification of patients without hemodynamic instability but with acute pulmonary embolism into intermediate- and low-risk categories.
Further, systemic thrombolytic therapy was recommended for high-risk patients. The recommendations were based off data from nearly 2000 patients who demonstrated significant reductions in pulmonary embolism-related morality (3% vs .6%; OR, .29; 95% CI, 0.14-0.6) and recurrent pulmonary embolism (2.9% vs 1.3%; OR, .5; 95% CI, .27-.94) at the cost of severe bleeding (9.9% vs 3.6%; OR, 2.91; 95% CI, 1.95-4.36) and intracranial hemorrhage (1.7% vs .3%; OR, 3.18; 95% CI, 1.25-8.11).
They recommended percutaneous catheter-directed treatment or surgical embolectomy as alternative treatments for such patients, despite less evidence supporting the therapies.
System thrombolysis was not recommended as an initial therapy for intermediate-risk patients, however, largely due to high rates of major bleeding (11.5% with tenecteplase vs 2.4% with placebo) and hemorrhagic stroke (2% vs .2%) with no significant difference in death (1.2% vs 1.8%).
The study, “ETNA-VTE Europe: Benefits and risks of venous thromboembolism treatment using edoxaban in the first 3 months,” was published online in Thrombosis Research.but thann