New Anticoagulant Pill Works Well in Trial

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There was an increase in bleeding episodes with rivaroxaban. Over six months, the researchers found that risk increased with dosage. At 5 milligrams, the risk increased 2.2 times, while the 20-milligram dose raised the risk fivefold.

However, patients receiving rivaroxaban had a 21 percent reduction in heart attacks, strokes, ischemic events and deaths compared with patients taking placebo. For heart attack, stroke and death alone, the risk was reduced by 31 percent compared with placebo, the researchers found.

"In this study, rivaroxaban was associated with a dose-dependent increase in clinically significant bleeding events, with a trend towards a reduction in the primary efficacy endpoint of death, myocardial infarction, stroke or severe recurrent ischemia requiring revascularization," Mega and colleagues wrote. "Regarding the main secondary efficacy endpoint, rivaroxaban reduced the rate of death, myocardial infarction or stroke."

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Dr. Hitinder S. Gurm, from the University of Michigan Cardiovascular Center and co-author of an accompanying journal editorial, said the study showed no benefit in patients who are using aspirin and Plavix, although there was a suggestion of a benefit when the drug was used with aspirin alone.

"This study was a dose-finding study; it would be premature to assess the future of this drug in patients with acute coronary syndrome based on this trial, and the little bit of data that we have does not suggest the drug would provide a major benefit in patients who are already on contemporary therapy -- with the caveat that we need a larger trial to confirm or refute this," Gurm said.

Dr. Richard C. Becker, director of the Cardiovascular Thrombosis Center at Duke University Medical Center, said this study is another step in the search for an anti-clotting drug to replace warfarin for many patients. Warfarin is an effective drug, but requires constant monitoring to assure that patients are receiving a dose that is not too low, which is ineffective, or too high, which increases the risk of bleeding.

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