Stephan Moll, MD writes…
The large clinical trial comparing Xarelto (Rivaroxaban) with warfarin in the treatment of patients with newly diagnosed pulmonary embolism (PE) was published in the New England Journal of Medicine March 26th, 2012, showing that Xarelto was (a) as effective as warfarin in preventing new clots, (b) caused the same amount of overall clinically relevant bleeding, and (c) caused less major bleeding.
- This was a large trial: 4,832 patients with acute PE with or without DVT were enrolled and treated either (a) with Xarelto (15 mg twice daily for 3 weeks, followed by 20 mg once daily), or (b) with standard therapy with enoxaparin (Lovenox) followed by warfarin with a target INR 2-3. Length of treatment varied, depending on patient characteristics, between 3 to 12 months.
- The main points investigated were (a) how many patients had recurrent clots (composite of fatal or nonfatal PE or DVT), (b) how many patients had clinically relevant bleeding occurred, and how many patients had severe/major bleeds.
- DVT and PE recurrences: 2.1 % in the Xarelto-treated patients, versus 1.8 % in the warfarin-treated patients–statistically the same.
- Clinically relevant bleeding: 10.3 % in the Xarelto-treated patients, versus 11.4 % in the warfarin-treated patients – statistically the same.
- Major bleeding: 1.1 % in the Xarelto-treated patients, versus 2.2 % in the warfarin-treated patients – which is statistically less in the Xarelto group.
- Xarelto, given from the get-go to patients with acute PE, was as effective as warfarin in preventing recurrent clots, had a similar rate of clinically relevant bleeding, and caused less major bleeding.
The Other New Anticoagulants
The four new oral anticoagulant drugs that are at present of most relevance to patients and physicians are (a) Pradaxa® (Dabigatran), (b) Xarelto® (Rivaroxaban), (c) Eliquis® (Apixaban), and (d) Savaysa® (Edoxaban). Clinical-practical relevant information on these drugs is discussed in various Clot Connect blogs.
- The EINSTEIN-PE Investigators. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med 2012;pre-published March 26th, 2012 ahead of print).
- EINSTEIN investigators. Oral Rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010;363:2499-2510.
Disclosure: I have consulted for OthoMcNeil and Bayer, the companies developing Xarelto.
Last updated: Dec 17th, 2012