APEX, 2016 trial summary

A randomised clinical trial investigating the effect of betrixaban versus enoxaparin in

NCT01583218    N Engl J Med 2016 May 27;:  




Studied treatment betrixaban (at a dose of 80 mg once daily) for 35 to 42 days
Control treatment subcutaneous enoxaparin (at a dose of 40 mg once daily) for 10±4 days



Patients
Group sizes 3759 / 3754
DVT diagnosis
PE diagnosis



Blindness double-blind Inclusion period
Follow-up duration Centers
Lost to FU geographical localisation
Primary endpoint asymptomatic proximal deep-vein thrombosis and symptomatic venous thromboembolism Design



EndpointX1N1X0N0TE95% CI Venous thromboembolism or death 132 1914 166 1956 0,81[0,64; 1,03] DVT - -9 - -9 no data PE - -9 - -9 no data VTE 132 1914 166 1956 0,81[0,64; 1,03] fatal PE - -9 - -9 no data proximal deep-vein thrombosis 132 3759 166 3754 0,79[0,63; 1,00] Major bleeding during follow-up - -9 - -9 1,19[0,67; 2,12] All-cause death during follow-up - -9 - -9 no data Asymptomatic deep vein thrombosis during follow-up. - -9 - -9 no data Symptomatic deep vein thrombosis during follow-up - -9 - -9 0,81[0,65; 1,00] Symptomatic pulmonary embolism during follow-up 132 3759 166 3754 0,79[0,63; 1,00] net clinical benefit 141 1914 174 1956 0,83[0,66; 1,04] Clinically relevant bleeding - -9 - -9 no data0,22,01,0


Cohen AT, Harrington RA, Goldhaber SZ, Hull RD, Wiens BL, Gold A, Hernandez AF, Gibson CM Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients. N Engl J Med 2016;:     [PMID: 27232649]   link to pdf  

Cohen AT, Harrington RA, Goldhaber SZ, Hull RD, Wiens BL, Gold A, Hernandez AF, Gibson CM Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients. N Engl J Med 2016 May 27;:     [PMID: 27232649]   link to pdf  



Registering number NCT01583218 (see trial on clinicaltrials.gov)
Code Name