Makers of Xarelto Say No Increased Risk of Coronary Stent Bleeding In Industry-funded Study

The findings of a new study funded by the makers of Xarelto indicates that the controversial new-generation anticoagulant does not increase the risk of bleeding events as much as the older drug warfarin, when used with Plavix following coronary stent surgery. 

According to research published last week in the New England Journal of Medicine, when low doses of Xarelto are used with drugs like Plavix among patients with atrial fibrillation who recently underwent coronary stent implantation, there is less of a risk of bleeding than if the patient had taken the older blood thinner warfarin instead.

The clinical trial, funded by Janssen Scientific Affairs and Bayer Pharmaceuticals, involved 2,124 participants diagnosed with nonvalvular atrial fibrillation who had undergone stenting and were prescribed either a low dose of Xarelto, a very low dose of Xarelto or warfarin, in combination with dual antiplatelet therapy (DAPT), which typically involves aspirin and Plavix.

According to the findings, patients given low doses of Xarelto (15mg once daily) had a 16.8% risk of significant bleeding, while patients given two 2.5mg doses per day had an 18% risk. That compared to 26.7% of patients given warfarin who experienced serious bleeding. The rates of death, heart attacks and strokes were similar in all three groups, researchers indicated.

The findings came just days after Asian and European researchers warned that dual antiplatelet therapy increased the bleeding risk of patients with coronary stents the longer individuals are on the drugs, and warned that the aspirin/Plavix combo does not appear to actually prevent heart problems in patients who receive the stents, as some doctors believe.

Coronary stents are often implanted in patients with blockages in the arteries due to heart disease. The stents prop the artery open to keep the supply of blood to the heart flowing. Sometimes they are bare metal and other types are coated with heart medications. However, in some cases a blood clot can form in the stent, which would reduce the flow of blood to the heart and could also break off and cause a pulmonary embolism, so some patients are prescribed blood thinners, typically being placed on a dual antiplatelet therapy regimen that includes Aspirin and a blood thinner like Plavix, Effient or Brilinta.

Xarelto Lawsuits Over Bleeding Problems

Xarelto (rivaroxaban) is part of a new class of blood thinners introduced in recent years as a replacement for warfarin, which had been the go-to anticoagulation treatment for decades. Since it was approved in 2011, this new-generation treatment has been commonly prescribed instead of warfarin for reduction of the risk of blood clots and strokes among patients with atrial fibrillation, or following hip or knee replacement surgery.

Amid allegations that the drug makers failed to adequately warn about the risk of bleeding associated with the new-generation drug, more than 11,000 Xarelto lawsuits have been filed in courts throughout the U.S., each raising similar allegations that plaintiffs suffered severe and sometimes fatal injuries due to uncontrollable bleeding while on the medication.

While users of warfarin can be given a dose of vitamin K to reduce the blood thinning effects of the medication, there were no similar reversal agents available for Xarelto at the time it was introduced, placing doctors in a position where they were unable to control many bleeding problems.

Lawsuits also allege that the drug makers provided false and misleading information about the importance of blood monitoring on Xarelto, marketing the drug as easier to use and indicating that it does not require close testing like warfarin. However, independent studies published after the medication was introduced have suggested that Xarelto monitoring may help identify patients at greater risk of bleeds.

As part of the coordinated proceedings in the federal Xarelto litigation, a small group of “bellwether” cases are being prepared for early trial dates, which are expected to begin early next year to help gauge how juries may respond to certain evidence that has been obtained during the discovery process.

While the outcome of these early bellwether trials will not be binding in other cases, they may facilitate Xarelto settlement negotiations that will avoid the need for thousands of individual cases to go to trial nationwide.