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Rivaroxaban (and similar agents) for extended prophylaxis of venous thrombosis in high risk medical patients – equal efficacy but increased bleeding

Samuel Z. Goldhaber, M.D.
March, 2013

MAGELLAN is the latest study of extended duration venous thromboprophylaxis among high risk medical patients that fails to achieve both efficacy and safety when a month of daily low-dose anticoagulation (rivaroxaban 10 mg once daily) is compared with about 10 days of standard low-dose enoxaparin 40 mg daily. The patient population is selected to be at high risk of developing DVT or PE within one month of hospitalization. Discharged patients receiving extended anticoagulation were expected to suffer few venous thromboembolic events without an increase in bleeding complications.

MAGELLAN had better efficacy with fewer clotting events but more bleeding (see table below). It joins the EXCLAIM trial comparing 10 days versus 30 days of enoxaparin. EXCLAIM had a similar outcome. Another megatrial, ADOPT, compared extended-duration low-dose apixaban with 10 days of low-dose enoxaparin. Apixaban in the ADOPT Trial did not achieve improved efficacy and had a slightly higher bleeding rate.

The only soldier left standing is the APEX Trial of standard duration low-dose enoxaparin versus extended duration betrixaban. This trial will take several years to complete.

It seems that in all of these trials, finding the ideal medical patient for extended-duration anticoagulation remains the biggest challenge.

Summary of key findings of the MAGELLAN study n=8101 patients
Treatment Thrombosis* Bleeding** Net effect***
10 +/- 4 day course
Riva. 10 mg + Enox. placebo 2.7% 2.8% 6.6%
Riva. placebo + Enox. 40 mg 2.7% 1.2% 4.6%
Extended course to 35 +/- 4 days
Riva. 10 mg 4.4% 4.1% 9.4%
Riva. placebo 5.7% 1.7% 7.8%
*Thrombosis = symptomatic or asymptomatic proximal venous thrombosis
**Bleeding = major or clinically relevant non-major bleeding
***Net effect = thrombosis + bleeding (totals differ because of time periods considered)
Riva.= rivaroxaban, enox.= enoxaparin

Reference

Cohen AT, Spiro TE, Büller HR, et. al. Rivaroxaban for thromboprophylaxis in acutely ill medical patients. N Engl J Med. 2013 Feb 7;368(6):513-23. doi: 10.1056/NEJMoa1111096.

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Friday, August 01, 2014