ORLANDO, FLA. ― Added to standard medical treatment, the anti-clotting drug rivaroxaban lowered risk of death, heart attack and stroke in acute coronary syndrome patients, according to late-breaking research presented at the American Heart Association’s Scientific Sessions 2011.
The study is simultaneously published in the New England Journal of Medicine.
Acute coronary syndrome is an umbrella term for heart attacks and chest pain known as unstable angina — conditions in which the heart’s blood supply is suddenly reduced.
“Despite our best efforts at treatment following a recent heart attack or unstable angina, patients still face a 10 percent or higher risk of a repeat heart attack, stroke or death one year later,” said C. Michael Gibson, M.D., senior investigator of the TIMI Study Group, Harvard Medical School, and the Principal Investigator in the ATLAS ACS studies of rivaroxaban for this indication.
“We know that people with a heart attack or unstable angina make too much thrombin, an enzyme that forms clots. We looked at whether reducing the production of thrombin with rivaroxaban reduces the risk of death, stroke or heart attack.”
Researchers analyzed more than 15,000 people hospitalized with a recent heart attack or unstable angina in the Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects with Acute Coronary Syndrome-Thrombolysis in Myocardial Infarction 51 Trial (ATLAS ACS 2-TIMI 51). Study participants were randomized to receive either standard care along with rivaroxaban or standard care with placebo.
Researchers followed these patients for an average of more than a year and found:
- Those who took rivaroxaban had a 16 percent reduced risk of cardiovascular death, stroke or heart attack compared to patients who didn’t.
- The risk of death, including all causes of death, was reduced more than 30 percent with the addition of rivaroxaban.
- Stent thrombosis was reduced by 31 percent in patients taking rivaroxaban compared to patients who didn’t.
- As with other types of anticoagulants, more internal bleeding occurred among those who took rivaroxaban than those who took placebo and the increase in TIMI major bleeding was significant. However, there was no increase in fatal bleeding.
Rivaroxaban and other new oral anticoagulants have demonstrated the ability to reduce strokes in patients with atrial fibrillation, but their use in patients with acute coronary syndrome has had mixed results. Because these patients are often on other anti-clotting medications, the bleeding risk has been very high.
“Our findings are important because blocking the production of thrombin is an important new way to improve acute coronary syndrome patients’ long-term risk of death, stroke and heart attack after being hospitalized with an acute coronary syndrome,” Gibson said.
Co-authors are Eugene Braunwald, M.D., and Jessica Mega, M.P.H., M.D.
Disclosures are here: http://newsroom.heart.org/pr/aha/document/Disclosures_for_LBCT.xlsx.
Johnson and Johnson and Bayer HealthCare funded the study.
Statements and conclusions of study authors that are presented at American Heart Association scientific meetings are solely those of the study authors and do not necessarily reflect association policy or position. The association makes no representation or warranty as to their accuracy or reliability. The association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events. The association has strict policies to prevent these relationships from influencing the science content. Revenues from pharmaceutical and device corporations are available at www.heart.org/corporatefunding .
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