Patients who took Bayer AG and Johnson & Johnson’s Xarelto with blood-thinning treatment after a severe heart attack had a better chance of surviving without another attack or stroke compared with placebo, a study found.
The 7,817 patients studied had a more serious type of heart attack that is typically caused by a blood clot completely blocking the coronary artery, leading to damage and the death of heart muscle. The treatment period was 24 months.
Xarelto is approved in the U.S. to prevent venous clots in patients undergoing knee and hip surgeries and to prevent stroke in people with atrial fibrillation. It’s surprising that a benefit in mortality could be seen in such a small group because normally it wouldn’t be statistically significant, Frank Misselwitz, head of Leverkusen, Germany-based Bayer’s cardiovascular unit, said in a telephone interview.
“This is, if you wish, a paradigm shift and has the potential to position rivaroxaban in a specific way, and not just as a drug used on the venous side,” he said, referring to Xarelto by its active ingredient.
Anticoagulants like Xarelto dissolve existing blood clots while antiplatelet therapies prevent components of the blood from clumping together and forming a clot.
Prior to this study, patients who suffered a severe heart attack known as ST-segment elevation myocardial infarction, or STEMI, weren’t given long-term treatment with anticoagulants such as warfarin in combination with antiplatelet drugs like Bayer’s Aspirin and Plavix from Sanofi and Bristol-Myers Squibb Co. That’s because of concern that that would cause a “massive increase in bleeding,” Misselwitz said.
Today’s data, presented at the European Cardiology Conference in Munich, shows a low dose of anticoagulant Xarelto in combination with an antiplatelet can offer a benefit, Misselwitz said. Patients who received 2.5 milligrams of Xarelto twice a day saw the most benefit, though with more bleeding than the placebo, Misselwitz said.
Patients who took a larger 5 milligram dose didn’t see the same benefit and had a higher risk of bleeding as a side effect, according to slides presented at the conference today. The findings in that group weren’t statistically significant.
About one-third of the 300,000 patients who have acute coronary syndrome in the U.S. every year suffer STEMI, Misselwitz said. Bayer has included the data in dossiers that governments consult when setting prices for the drug, which competes with Boehringer Ingelheim GmbH’s Pradaxa. Bayer still expects Xarelto will have peak annual sales of 2 billion euros ($2.5 billion), Misselwitz said.
Today’s study was a subset of about half of patients with acute coronary syndrome in a study known as Atlas, which looked at rates of heart attack, stroke and death.
“After heart attack, our traditional treatment is to keep people on antiplatelet therapy,” Spencer King, former president of the American College of Cardiology and professor emeritus of Emory University in Atlanta, said in an interview today. “This study seems to indicate that anticoagulants, though with increased bleeding, somewhat decrease mortality.” King wasn’t involved in the study.
Bayer and J&J of New Brunswick, New Jersey, await a ruling from European regulators to expand the use of Xarelto to prevent heart attacks and strokes in patients with serious chest pain or a previous heart attack. The companies said June 22 they failed to get approval from the U.S. Food and Drug Administration for a 2.5 milligram dose of Xarelto in the same group of patients, saying the agency had questions about their application.