ADVANCE-2
ADVANCE-3
*Total Venous Thromboembolism/all-cause death: composite of asymptomatic and symptomatic Venous Thromboembolism, non-fatal PE and all-cause death.3
†Major VTE: composite of asymptomatic and symptomatic proximal DVT, non-fatal PE and Venous Thromboembolism-related death.3
†Major VTE: composite of asymptomatic and symptomatic proximal DVT, non-fatal PE and Venous Thromboembolism-related death.3
Inclusion criteria:3
Patients were eligible for inclusion if they were scheduled to undergo unilateral elective total knee replacement or same-day bilateral knee replacement, including revision.
Key exclusion criteria:3
Key exclusion criteria included the following:
- Active bleeding
- Contraindication to anticoagulant prophylaxis
- Need for ongoing anticoagulant or antiplatelet treatment
- Uncontrolled hypertension
- Active hepato-biliary disease
- Impaired renal function
- Thrombocytopenia
- Anemia
- Heparin allergy
- Allergy to radiographic contrast dye
- Other disorders preventing venography
Adapted from Lassen MR, et al. Lancet. 2010.
§Seven patients in the apixaban group and 11 in the enoxaparin group had clinically relevant non-major bleeding events that occurred before the first postsurgery dose of study drug.3
ǁFive patients in the apixaban group and five in the enoxaparin group had major bleeding events that occurred before the first postsurgery dose of study drug.3
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Major bleeding3: Acute, clinically overt bleeding accompanied by at least one of the following criteria:
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CRNM bleeding3: Acute, clinically overt bleeding that does not satisfy criteria for major bleeding and meets at least one of the following criteria:
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Click here for Eliquis® 2.5mg Prescribing Information Click here for Eliquis® 5mg Prescribing Information |
 HF0098OA456/122022
Invalidation Date : 21/08/2024 |
SPAF Aristophanes
VTE prevention Efficacy
*Total Venous Thromboembolism/ all-cause death: composite of asymptomatic and symptomatic Venous Thromboembolism, non-fatal PE and all-cause death.3
+Major VTE: composite of asymptomatic and symptomatic proximal DVT, non-fatal PE and Venous Thromboembolism- related death.3
+Major VTE: composite of asymptomatic and symptomatic proximal DVT, non-fatal PE and Venous Thromboembolism- related death.3
Inclusion criteria:3
Patients were eligible for inclusion if they were scheduled to undergo elective THR or revision of a previously inserted hip prosthesis.
Key exclusion criteria: 3
Key exclusion criteria included the following:
- Active bleeding
- Contraindication to anticoagulant prophylaxis
- Need for ongoing anticoagulant or antiplatelet treatment
- Uncontrolled hypertension
- Active hepato-biliary disease
- Impaired renal function
- Thrombocytopenia
- Anemia
- Heparin allergy
- Allergy to radiographic contrast dye
- Other disorders preventing venography
Adapted from Lassen MR, et al. Lancet. 2010.
Major bleeding was defined as acute clinically overt bleeding accompanied by one or more of the following: a decrease in blood haemoglobin concentration of 2 g/dL or more during 24 hours; transfusion of two or more units of packed red blood cells; bleeding occurring in equal or more than critical sites (including intracranial, intraspinal, intraocular, pericardial or retroperitoneal bleeding); bleeding into the operated joint needing reoperation or intervention; intramuscular bleeding with compartment syndrome; or fatal bleeding.
Doesn't satisfy criteria for major bleeding and meets at least one of the following: wound haematoma, bruising or ecchymosis, GI bleeding, haemoptysis, haematuria or epistaxis that did not meet criteria for major efficacy outcome for non-inferiority using a prespecified margin in which the upper limit of the 95% CI for RR should not exceed 1.5, and if this occurred to then test for superiority.
References: 1. Eliquis 2.5 mg/ 5 mg Egyptian Drug Authority approved leaflet 17/08/2022. Revision Date: February 2022. 2. Agnelli G, Buller HR, Cohen A, et al. Apixaban for extended treatment of venous thromboembolism. N Engl J Med. 2013;368(8):699-708. 3. Lassen MR, Raskob GE, Gallus A, Pineo G, Chen D, Hornick P; ADVANCE-2 investigators. Apixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE-2): a randomized double-blind trial. Lancet. 2010;375(9717):807-815.
VTE treatment Guideline Recommendations
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Click here for Eliquis® 2.5mg Prescribing Information Click here for Eliquis® 5mg Prescribing Information |
HF0098OA456/122022
Invalidation Date : 21/08/2024 |
SPAF Persistence and Adherence
VTE treatment Real-world Data
PP-ELI-EGY-0467