Extended Apixaban Therapy Lowers Recurrent Vte In Patients With Provoked Events And Enduring Risk Factors

Apixaban 2.5 mg doubly regular importantly reduced symptomatic venous thromboembolism (VTE) recurrence, pinch a debased consequence of awesome bleeding, successful patients pinch provoked VTE and enduring consequence factors, according to late-breaking investigation presented successful a Hot Line convention coming astatine ESC Congress 2025 and simultaneously published successful New England Journal of Medicine.

People tin create a humor clot that blocks a vein (VTE) because of short-term factors, specified arsenic room aliases injury, aliases arsenic a consequence of a chronic aesculapian condition, specified arsenic cancer.

Explaining nan rationale of nan HI-PRO trial, Principal Investigator, Doctor Gregory Piazza from Brigham and Women's Hospital, Boston, USA, said: "Patients pinch acute VTE pinch transient provoking factors, specified arsenic surgery, trauma aliases immobility, typically person short-term anticoagulation. However, nan consequence of VTE recurrence whitethorn stay precocious successful definite patients pinch enduring consequence factors, including those pinch obesity, chronic lung illness aliases autoimmune disorders. In specified patients, nan optimal long of anticoagulation is uncertain. We designed nan HI-PRO proceedings to measure nan efficacy and information of extended-duration apixaban 2.5 mg doubly daily, compared pinch placebo, for nan prevention of recurrence successful patients pinch provoked VTE and astatine slightest 1 enduring consequence factor."

The double-blind, randomized controlled HI-PRO proceedings was conducted astatine Brigham and Women's Hospital. Eligible patients had deep vein thrombosis (DVT) aliases pulmonary embolism (PE) pursuing a awesome provoking facet (e.g. awesome room aliases awesome trauma), had completed astatine slightest 3 months of standard-dose anticoagulation and had astatine slightest 1 enduring consequence facet (e.g. assemblage wide scale [BMI] ≥30 kg/m2, chronic lung illness aliases chronic inflammatory disease). Patients were randomized 1:1 to apixaban 2.5 mg doubly regular aliases placebo for 12 months. The superior efficacy result was symptomatic recurrent VTE, a composite of DVT and/or PE astatine 12 months. The main information result was awesome bleeding according to nan International Society connected Thrombosis and Haemostasis definition.

In total, 600 patients underwent randomization. The mean property was 59.5 years and 57% were female. The astir communal provoking factors were room (33.5%), immobility (31.3%), trauma (19.2%) and acute aesculapian unwellness (18.3%). The astir communal enduring consequence factors were chronic inflammatory upset (52.2%), BMI ≥30 kg/m2 (48.2%), atherosclerotic cardiovascular illness (29.3%) and chronic lung illness (22.3%).

Symptomatic recurrent VTE occurred successful 1.3% of patients successful nan apixaban group compared pinch 10.0% successful nan placebo group, representing a important 87% alteration (hazard ratio [HR] 0.13; 95% assurance interval [CI] 0.04 to 0.36; p<0.001). A secondary composite result of cardiovascular death, non-fatal myocardial infarction, stroke/transient ischemic onslaught aliases systemic embolism, awesome adverse limb event, and coronary aliases peripheral ischemia requiring revascularization occurred pinch a likewise debased wave pinch apixaban and placebo (0.7% vs. 1.0%, respectively; HR 0.67; 95% CI 0.11 to 3.98).

Major bleeding occurred successful 1 diligent (0.3%) who received apixaban and nary who received placebo. Clinically applicable non-major bleeding was observed successful 4.8% of patients successful nan apixaban group and 1.7% successful nan placebo group (HR 2.68; 95% CI 0.96 to 7.43; p=0.059). Death occurred successful 1 diligent successful nan apixaban group and 3 successful nan placebo group, pinch nary deaths owed to cardiovascular aliases hemorrhagic causes. Adverse events different than bleeding aliases decease occurred successful 2.0% of patients successful some groups.

Low-intensity apixaban for 12 months efficaciously reduced symptomatic VTE recurrence pinch a debased consequence of awesome bleeding successful patients pinch provoked VTE and enduring consequence factors. Additional investigation is needed to place which subgroups use astir from extended anticoagulation."

Doctor Gregory Piazza, Brigham and Women's Hospital, Boston, USA