Treatment of Venous Thromboembolism: the EINSTEIN Programme
The EINSTEIN clinical trial programme comprises three randomized phase III studies of rivaroxaban for the treatment of venous thromboembolism (VTE) and the long-term prevention of recurrent VTE. It is the only clinical programme that has investigated a new oral anticoagulant for the treatment of acute deep vein thrombosis (DVT) and treatment for acute pulmonary embolism (PE) in separate trials.
- EINSTEIN DVT: rivaroxaban versus enoxaparin plus a vitamin K antagonist (VKA) in the treatment of acute DVT without symptomatic PE96
- EINSTEIN PE: rivaroxaban versus enoxaparin plus a VKA in the treatment of acute PE with or without symptomatic DVT121
- EINSTEIN EXT: rivaroxaban versus placebo in the long-term prevention of recurrent, symptomatic VTE in patients who had already received 6–12 months of anticoagulant treatment for DVT or PE96
- 96 - The EINSTEIN Investigators. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010;363:2499–2510.
- 121 - The EINSTEIN–PE Investigators. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med 2012;366:1287–1297.
- Thrombosis
- Formation of a clot inside a blood vessel.
- Venous thromboembolism
- A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.
- Deep vein thrombosis
- A blood clot in a deep vein, usually resulting from damage to the vein or blood flow slowing down or stopping. Usually DVTs are found in the leg, but can also be in the arm. Distal DVTs are found in deep veins of the calf, and are the most common type of DVT. Proximal DVTs are found in the legs above the calf muscle up to the waist.
- Pulmonary embolism
- A potentially fatal condition caused by a blood clot blocking a vessel in the lung: usually the clot originates from a DVT in the legs. PE can result in permanent lung damage.
- Vitamin K antagonist
- An anticoagulant that inhibits multiple steps in the blood clotting process. Administered orally, the dose varies by patient, and regular monitoring and dose adjustment is required. Vitamin K antagonists have interactions with food and other drugs. Due to the many limitations of this drug, many patients are actually not treated and many of those who are treated are outside of the required target INR range, which can be the cause for increased bleeding or a greater risk of stroke.
