This article is more than 5 years old. Information may no longer be current.
Betrixaban associated with reduced stroke risk vs. enoxaparin in acutely ill patients
NEW ORLEANS — In patients hospitalized for an acute medical illness, betrixaban, a novel Factor Xa inhibitor, was associated with reduced all-cause stroke and ischemic stroke compared with enoxaparin, according to a substudy from the APEX trial.
The researchers randomly assigned 7,513 patients hospitalized for an acute medical illness (mean age, 76 years; 45% men; 13% with stroke; 45% with congestive HF) to extended-duration oral betrixaban (Portola Pharmaceuticals) 80 mg once daily for 35 to 42 days or standard-dose enoxaparin 40 mg once daily for 6 to 14 days.
In the main results of the APEX trial, the primary composite efficacy outcome of asymptomatic proximal deep vein thrombosis between day 32 and day 47, symptomatic proximal or distal deep vein thrombosis, symptomatic nonfatal pulmonary embolism or death from venous thromboembolism between day 1 and day 42 was not met, but there was a signal that betrixaban may be associated with reduction in VTE risk. There was no difference between the groups in bleeding.
In the present analysis, conducted retrospectively, the outcome of interest was stroke at 77 days. The findings were presented by C. Michael Gibson, MD, MS, from the cardiovascular division of the department of medicine at Beth Israel Deaconess Medical Center and Harvard Medical School, at the American Heart Association Scientific Sessions and published in Circulation.
Compared with those assigned enoxaparin, those assigned betrixaban at 77 days had lower rates of all-cause stroke (0.54% vs. 0.97%; RR = 0.56; 95% CI, 0.32-0.96; number needed to treat = 233) and ischemic stroke (0.48% vs. 0.91%; RR = 0.53; 95% CI, 0.3-0.94; number needed to treat = 233), according to the researchers.
The effect of betrixaban vs. enoxaparin on stroke outcomes was more pronounced in those with congestive HF or stroke as their hospitalization event (all-cause stroke, 0.72% vs. 1.48%; RR = 0.49; 95% CI, 0.26-0.9; number needed to treat = 132; ischemic stroke, 0.63% vs. 1.38%; RR = 0.45; 95% CI, 0.24-0.87; number needed to treat = 134), Gibson and colleagues found.
“It could be argued that the reduction in stroke was due to play of chance,” the researchers wrote in Circulation. “The association, however, of prior stroke and congestive [HF] with recurrent stroke and the fact that these subjects sustained the greatest event reduction supports the biologic plausibility of the observation.”
Betrixaban is not yet approved for use in the United States. – by Erik Swain
References:
Gibson CM, et al. Abstract 277. Presented at: American Heart Association Scientific Sessions; Nov. 12-16, 2016; New Orleans.
Gibson CM, et al. Circulation. 2016;doi:10.1161/CIRCULATIONAHA.116.025427.
Disclosure: The study was funded by Portola Pharmaceuticals. Gibson reports receiving grant support and consultant fees from Bayer, Janssen and Portola.
