Xarelto Linked To Increased Risk Of Bleeding, Death, After Transcatheter Aortic-Valve Replacement (TAVR) Surgery: Study

For individuals who recently underwent transcatheter aortic-valve replacement (TAVR), new research suggests that side effects of Xarelto appear to carry a higher risk of bleeding than use of antiplatelet-based blood thinners, according to the findings of new research.

In a study published this month in the New England Journal of Medicine, an international group of researchers working on a clinical trial, known as GALILEO, report that Xarelto increased the risk of life-threatening bleeding events by up to 50%, and the risk of death by nearly 70%, when compared to patients given aspirin or Paxil.

Xarelto (rivaroxaban) is the leading member of a new generation of direct oral anticoagulants, which are marketed as superior alternatives for prevention of blood clots with atrial fibrillation and other conditions. However, there have been thousands of reports involving serious and uncontrollable bleeding problems from Xarelto, often resulting in severe injury or death.

TAVR is a type of heart procedure that allows the surgeon to replace the heart valve by threading it through an artery in the leg instead of via open chest surgery. It places the valve over the damaged aortic valve in a less invasive procedure.

Initially, TAVR was approved only in high risk patients who were frail or couldn’t undergo open heart surgery because the procedure carried such high risks. More so, the durability of the heart valves was untested for use in younger patients who would outlive the devices that were designed to last 10 years, not 30 or more years.

In this latest study, researchers randomly assigned 1,644 recent TAVR patients to either Xarelto or aspirin. For the first three months, the Xarelto group was prescribed aspirin, and the aspirin group was prescribed Paxil, but then those secondary drugs were stopped, and the patients just used Xarelto or aspirin alone. However, the study was halted prematurely due to concerns for the safety of the patients.

After a median of 17 months, the researchers found that 46 of the Xarelto patients suffered major, disabling, or life-threatening bleeding events, compared to only 31 of the aspirin patients; a 50% increased risk. In addition, 64 Xarelto patients died, compared to 38 of the aspirin patients; which was a 64% increased risk.

“In patients without an established indication for oral anticoagulation after successful TAVR, a treatment strategy including rivaroxaban at a dose of 10 mg daily was associated with a higher risk of death or thromboembolic complications and a higher risk of bleeding than an antiplatelet-based strategy,” the researchers concluded.

A similar study published in 2018 found that Xarelto failed to lower the risk of blood clots or death in hospital patients who were bedridden. Another study published in 2018 found that Xarelto failed to prevent death in heart failure patients.

Incidents of unstoppable bleeding have resulted in thousands of reports involving injury or death for patients using the new drugs. About 30,000 Xarelto lawsuits were filed against the drug makers, alleging that users and the medical community were not adequately warned about the risk of problems linked to the drug.

Following a handful of early bellwether trials, which were held before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana to help gauge how juries may respond to certain evidence and testimony that was likely to be repeated throughout the litigation, a global Xarelto settlement was reached in March 2019, resolving nearly all claims.