Now researchers at Brigham and Women’s Hospital (BWH), Beth Israel Deaconess Medical Center (BIDMC), and Harvard Medical School have investigated whether rivaroxaban can also help patients with an acute coronary syndrome (ACS). ACS is a collection of signs and symptoms (e.g., chest pain) caused by reduced blood flow to the heart.
The study will be electronically published in The New England Journal of Medicine on November 13. It will also be presented at this year’s American Heart Association’s Scientific Sessions in Orlando, Florida occurring Nov. 12-16.
The ATLAS ACS 2-TIMI 51 (Anti-Xa Therapy to Lower cardiovascular events in Addition to standard therapy in Subjects with Acute Coronary Syndrome) study found that, when added to standard medical treatment, rivaroxaban reduced the risk of heart attack, stroke or cardiovascular death in patients recently diagnosed with ACS.
The double-blind, placebo-controlled study ran from November 2008 to September 2011 and included 766 sites in 44 countries. Researchers randomized 15,526 participants who had been admitted to the hospital for ACS. Participants were randomized to receive either 2.5 milligrams of rivaroxaban, 5 milligrams of rivaroxaban, or placebo. The medications were given twice a day for an average of 13 months.
Researchers found that both doses of rivaroxaban reduced heart attack, stroke or cardiovascular death when compared to placebo, with a 16 percent decrease in the 2.5-milligram group and a 15 percent decrease in the 5-milligram group.
Looking specifically at death, the 2.5-milligram dose reduced cardiovascular death and all-cause death by 34 percent and 32 percent, respectively. Rivaroxaban also reduced clotting within coronary stents.
Although rates of major bleeding and intracranial hemorrhage (bleeding in or around the brain) were higher in participants taking rivaroxaban compared to those on placebo, there was not a significant increase in fatal bleeding or other adverse events. Between the two rivaroxaban doses, there was less fatal bleeding with the 2.5-milligram dose.
The study authors, Dr. Jessica Mega and Dr. Eugene Braunwald of BWH and Dr. C. Michael Gibson of BIDMC (all three of Harvard Medical School) said, “Despite medical therapy, angioplasty and stenting following an ACS, patients continue to be at risk of recurrent cardiovascular events. In ATLAS ACS 2-TIMI 51, a very low dose of rivaroxaban not only reduced the primary efficacy end point of cardiovascular death, myocardial infarction or stroke in patients with a recent ACS; it also resulted in a significant reduction in mortality. This regimen should be beneficial in the many thousands of patients discharged from hospitals following an ACS.”
This research was supported by Johnson & Johnson Pharmaceutical Research and Development and Bayer HealthCare.