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TAO: Otamixaban does not improve outcomes in NSTEACS
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AMSTERDAM — Compared with unfractionated heparin plus eptifibatide, otamixaban, a novel parenteral inhibitor of factor Xa, did not reduce ischemic events, but did increase bleeding in patients with non-ST-elevation ACS, according to results of the TAO trial.
The primary efficacy outcome of the trial, defined as the composite of all-cause death or new MI through 7 days, was similar between both groups (otamixaban, 5.5% vs. unfractionated heparin plus eptifibatide, 5.7%; adjusted RR=0.99; 95% CI, 0.85-1.16). Secondary endpoints, which included procedural thrombotic complications, were also comparable. However, the primary safety outcome of TIMI major or minor bleeding out to 7 days was significantly higher with otamixaban (3.1% vs. 1.5%; RR=2.13; 95% CI, 1.63-2.78). Results were similar across prespecified subgroups.
“These results suggest an unfavorable efficacy/safety balance for acute Xa inhibition in the modern era of dual antiplatelet therapy and routine early intervention for ACS,” P. Gabriel Steg, MD, professor of cardiology at the University of Paris, director of the coronary care unit, Hôpital Bichat – Claude Bernard and trial investigator, said during a press conference at ESC Congress 2013.
P. Gabriel Steg
The TAO trial was a randomized, double blind, active-controlled superiority trial that enrolled 13,229 patients with non-ST-elevation ACS (NSTEACS) and a planned early invasive strategy. Patients were randomly assigned to otamixaban (IV bolus of 0.080 mg/kg followed by an infusion of either 0.100mg/kg per hour or 0.140mg/kg per hour) with an interim analysis conducted for otamixaban dose selection, or to unfractionated heparin plus, at the time of PCI, eptifibatide (Integrilin, Merck). Patients were well-matched and typical of an ACS trial population, according to the study background.
In a previous phase 2, dose-ranging trial — SEPIA-ACS1 TIMI 42 — otamixaban showed a signal of efficacy compared with unfractionated heparin plus eptifibatide in more than 3,000 patients. These results coupled with the results of TAO show the importance of conducting a large, phase 3 trial to make accurate conclusions regarding efficacy and safety of a new agent, Steg said. – by Brian Ellis
For more information:
Steg PG. Hot Line I: Late breaking trials on thrombosis. Presented at: the European Society of Cardiology Congress; Aug. 31-Sept. 4, 2013; Amsterdam.
Steg PG. JAMA. 2013;doi:10.1001/jama.2013.277165.
Disclosure:The trial was funded by Sanofi-Aventis. See the study for a full list of author disclosures.