Rivaroxaban reduces combined risk of cardiovascular death, myocardial infarction, or stroke in ACS patients

February 1, 2012

An estimated 1.2 million Americans are discharged from a hospital with a diagnosis of acute coronary syndrome (ACS) each year. Now, a new randomized controlled trial dubbed "ATLAS ACS 2" (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to aspirin with/without thienopyridine therapy in Subjects with Acute Coronary Syndrome), is suggesting rivaroxaban may reduce the risk of the composite end point of death from cardiovascular causes, myocardial infarction, or stroke in patients with a recent ACS, but at a cost of increased major bleeding.

An estimated 1.2 million Americans are discharged from a hospital with a diagnosis of acute coronary syndrome (ACS) each year. Now, a new randomized controlled trial dubbed "ATLAS ACS 2" (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to aspirin with/without thienopyridine therapy in Subjects with Acute Coronary Syndrome), is suggesting rivaroxaban may reduce the risk of the composite end point of death from cardiovascular causes, myocardial infarction, or stroke in patients with a recent ACS, but at a cost of increased major bleeding.

The results of ATLAS ACS 2 were recently presented as a late breaker at the American Heart Association's 2011 Scientific Sessions, Orlando, Fla., and published in the January 5, 2012, edition of the New England Journal of Medicine.

According to Formulary Editorial Board Advisor Craig I. Coleman, PharmD, associate professor at the University of Connecticut School of Pharmacy in Storrs, Conn., "Even with the use of long-term dual antiplatelet therapy with aspirin and thienopyridines, ACS patients continue to be at high risk for repeat cardiovascular events." He continued, "While warfarin and investigational anticoagulants have been evaluated for their potential to reduce cardiovascular events following ACS, for numerous reasons, their accepted use in this setting has not come to fruition."

Perhaps not unexpectedly, rivaroxaban did increase both the rates of major bleeding not related to coronary-artery bypass grafting (2.1% vs 0.6%, P<.001) and intracranial hemorrhage (0.6% vs 0.2%, P=.009) compared to placebo.

Dr Coleman noted, "While serious bleeding was increased with rivaroxaban, it is reassuring to see that fatal bleeding was no higher in the rivaroxaban groups compared to placebo."

"It appears that the cardiovascular event reduction benefits outweigh the bleeding risks in this population, based upon the fact that the 2.5-mg dose of rivaroxaban reduced both the rates of death from cardiovascular and any cause," he continued.

Fueled by the results of ATLAS ACS 2, Janssen Pharmaceuticals has submitted a supplemental new drug application to FDA for the approval of rivaroxaban to reduce the risk of thrombotic cardiovascular events in ACS patients. FDA has granted the drug "fast-track" designation for this supplemental ACS indication.

SOURCE

Mega JL, Braunwald E, Wiviott SD, et al; ATLAS ACS 2–TIMI 51 Investigators. Rivaroxaban in patients with a recent acute coronary syndrome. N Engl J Med. 2012;366(1):9–19.