The results of a double-blind, controlled clinical trial the gold standard in medical testing bring welcome news to patients with acute coronary syndrome (ACS), meaning those with acute angina or heart attack. Presented at yesterday s American Heart Association Scientific Sessions and published in the New England Journal of Medicine, new research showed that low doses of Johnson & Johnson and Bayer s anticoagulant drug Xarelto prevented cardiovascular death, myocardial infarction, or stroke in ACS patients, when compared to a placebo.
Scientists conducting the study randomly assigned over 15,000 ACS patients to receive standard antiplatelet therapy, combined with either one of two doses of Xarelto or a placebo; they found that the risk of cardiovascular death was reduced by 34 percent among patients who took 2.5 mg of Xarelto twice daily. Patients taking the 5 mg dose of Xarelto, however, did not see a significantly reduced death rate. And, while both treatment groups showed increased rates of major bleeding, neither dose of Xarelto was accompanied by an excess risk of fatal bleeding, compared to placebo.
The results, then, are very promising. As senior investigator Dr. Michael Gibson notes, if the data from the current trial were extrapolated into clinical practice, we could potentially see one life saved for every 56 patients treated with this combination of therapies over a two year period.
Xarelto has already been approved to reduce the risk of stroke and systemic embolism (clots that travel through the circulation) in patients with atrial fibrillation. It also includes an indication to prevent deep vein thrombosis in patients undergoing knee or hip replacement surgery. Drugmakers are now seeking priority review from the FDA for the approved use of Xarelto in ACS patients, which ACSH s Dr. Gilbert Ross hopes will happen quickly. This study, unlike others we ve seen in the past, should be applauded for its well-executed design and protocol. He adds, As a physician, I would start prescribing Xarelto for my ACS patients immediately, based on the results of the current research, even though presently such use would be deemed off-label.