ESC: Savaysa Safe for Afib Cardioversion

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ROME -- Edoxaban (Savaysa) appears at least as safe as the standard warfarin (Coumadin)/enoxaparin (Lovenox) strategy for use in bridging anticoagulation around cardioversion for recent onset atrial fibrillation (afib), the ENSURE-AF trial showed.

Both regimens had a similarly low rate of the primary efficacy outcome of stroke, systemic embolic event, MI, and cardiovascular mortality, with five endpoint events on edoxaban versus 11 on enoxaparin/warfarin at 28 days after cardioversion (0.5% versus 1%, OR 0.46, 95% CI 0.12 to 1.43).

Likewise, the primary safety endpoint of major and clinically relevant non-major bleeding in patients who took their medication at least once came out at about 1% in both groups (OR 1.48, 95% CI 0.64 to 3.55), Andreas Goette, MD, of St. Vincenz Hospital in Germany, reported here at the European Society of Cardiology meeting.

Although some centers in the 19 countries where patients were treated in the trial used a transesophageal echocardiography [TEE]-guided strategy and others did not, this distinction did not affect the findings, the researchers noted.

Mark Creager, MD, of Dartmouth-Hitchcock Medical Center in Lebanon, N.H., and immediate-past president of the American Heart Association, said, "I think we can reasonably extrapolate the information to the other non-vitamin K oral anticoagulants" (NOACs) -- rivaroxaban (Xarelto) and apixaban (Eliquis) -- even though the study involved only edoxaban."

"It's consistent with other atrial fibrillation trials looking at these novel non-vitamin K oral anticoagulants [NOACs]," he told MedPage Today.

"The NOACs seem to be safe and user friendly, and provide rapid onset of oral anticoagulation; they provide an alternative to heparin plus warfarin," Goette's group agreed in the paper simultaneously released online in The Lancet.

Creager suggested that the similarity of the two strategies in the trial could further push adoption of the NOACs in this setting. "If efficacy is similar and safety is similar, ease of use is certainly an important thing."

"The main practical advantages of these drugs are their rapid onset of action and reliable anticoagulation properties, allowing for treatment initiation just hours before cardioversion when a TEE-guided approach is selected without the need to switch anticoagulants," Alexandros Briasoulis, MD, of the Mayo Clinic in Rochester, Minn., and Luis Afonso, MD, of Wayne State University in Detroit, wrote in an accompanying editorial in The Lancet.

However, they cautioned, "With a non-TEE-guided approach, careful assessment of adherence to NOACs in the preceding 3 weeks is mandatory, because no assay providing information on effective anticoagulation is available."

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The trial included 2,199 patients getting electrical cardioversion for non-valvular afib with onset from 48 hours to 12 months prior to enrollment. They were randomized to open-label (but blinded-endpoint evaluation) treatment with edoxaban at 60 mg per day or enoxaparin and warfarin. The dose of edoxaban was cut to 30 mg per day for patients with low creatinine clearance or body weight or concomitant use of P-glycoprotein inhibitors.