Savaysa Side Effects May Carry Higher Risk of Bleeding Than Warfarin For Heart Valve Replacement Patients: Study

The findings of a new study suggest the new blood thinner Savaysa may carry a higher risk of bleeding than warfarin for patients who have undergone transcatheter aortic-valve replacement (TAVR) surgery.

Researchers with the Icahn School of Medicine at Mount Sinai report that TAVR patients with atrial fibrillation had a higher rate of major bleeding events, particularly gastrointestinal bleeding, with Savaysa (edoxaban) than with vitamin K antagonists like warfarin. Their findings were published on August 28 in The New England Journal of Medicine.

Savaysa (edoxaban) is part of a new generation of blood thinners, which also includes the medications Xarelto, Pradaxa and Eliquis, which are prescribed for the prevention of strokes from atrial fibrillation. However, the drugs were originally linked to reports of uncontrollable bleeding problems, since they were released without reversal agents that doctors can use to quickly stop the blood thinning effects if problems arise. Reversal agents have since been developed which addressed these uncontrollable bleeding risks.

In this latest study, researchers looked at how Savaysa performed as a blood thinner for patients with atrial fibrillation following successful TAVR surgery, comparing it to the older drug warfarin. They conducted a multicenter open-label trial involving a total of 1,426 patients, with 713 patients in each group.

According to the findings, both drugs worked about the same at preventing strokes, death and blood clots, however, Savaysa was linked to a 40% increased risk of major bleeding events, mostly due to gastrointestinal bleeding linked to Savaysa.

“In patients with mainly prevalent atrial fibrillation who underwent successful TAVR, edoxaban was noninferior to vitamin K antagonists as determined by a hazard ratio margin of 38% for a composite primary outcome of adverse clinical events,” the researchers concluded. “The incidence of major bleeding was higher with edoxaban than with vitamin K antagonists.”

The study comes amid increased concerns over TAVR surgical outcomes in recent years.

TAVR is a type of heart procedure which 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 among high risk patients who were frail or could not undergo open heart surgery. The durability of the heart valves was also untested for use among younger patients, who may outlive the devices, which were originally designed to last 10 years, not 30 or more years.

A study published in the September 2020 issue of the journal JACC: Cardiovascular Interventions indicated more than one out of every hundred TAVR procedures requires surgical bailout, in which the surgical team has to convert to open heart surgery after experiencing unexpected complications, highlighting the risk of TAVR surgical bailouts.

In April, a TAVR mortality study presented at the virtual meeting of the Society for Cardiovascular Angiography and Interventions (SCAI) presented findings that even low-risk patients who underwent transcatheter aortic valve replacement (TAVR) may face an increased risk of death from inflammation developing in the heart’s inner lining.