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ENSURE-AF: Edoxaban reduces event rates after electrical cardioversion in nonvalvular AF
Patients with nonvalvular atrial fibrillation who were assigned edoxaban after electrical cardioversion had fewer events compared with those assigned enoxaparin plus warfarin, according to an ancillary analysis of the ENSURE-AF study published in The American Journal of Cardiology.
Gregory Y.H. Lip, MD, FRCP, DFM, FACC, FESC, professor of cardiovascular medicine at the Institute of Cardiovascular Sciences at University of Birmingham in the United Kingdom, and colleagues analyzed data from 2,199 patients who underwent electrical cardioversion for nonvalvular AF. Patients were assigned 60 mg per day edoxaban (Savaysa, Daiichi Sankyo; n = 1,095; mean age, 64 years) or enoxaparin plus warfarin (n = 1,104; mean age, 64 years).
The primary efficacy endpoint of interest was a composite of systemic embolic event, stroke, CV death and MI during the 28 days of the overall treatment period and 30-day follow-up. The primary safety endpoint was defined as a composite of clinically relevant nonmajor and major bleeding during the treatment period.
The CHA2DS2-VASc score was used to define stroke risk, and the HAS-BLED score assessed bleeding risk. These scores were also used to determine time to therapeutic range and time in therapeutic range in those assigned enoxaparin plus warfarin.
In both groups, the mean HAS-BLED score was 0.9 and the mean CHA2DS2-VASc score was 2.6. Patients at high risk for thromboembolism had a nonsignificant trend for lower ORs for the primary efficacy endpoint. Higher ORs were seen in those with a HAS-BLED score of at least 3.
The mean time in therapeutic range was greater than 67%, and there was no difference between stroke and bleeding risk.
There was an association between CHA2DS2-VASc score and time to therapeutic range (P = .0004), as those with higher scores were within the therapeutic range slightly sooner. Time in therapeutic range had an association with HAS-BLED score (P = .0286), and patients with higher scores had a lower time in therapeutic range.
Compared with patients assigned enoxaparin plus warfarin, those at high risk for stroke who were assigned edoxaban had fewer primary efficacy endpoint events, higher ORs and HAS-BLED scores greater than 3.
“Although event rates were low despite a mean CHA2DS2-VASc score of 2.6 and a mean HAS-BLED score of 0.9, our observations of a relation to [time to therapeutic range] and [time in therapeutic range] are exploratory and merit confirmation in larger prospective cohorts,” Lip and colleagues wrote. – by Darlene Dobkowski
Disclosures: ENSURE-AF was sponsored and funded by Daiichi Sankyo. Lip reports he served as a consultant for Bayer/Janssen, Biotronik, Boehringer Ingelheim, Bristol-Myers Squibb-Pfizer, Daiichi Sankyo, Medtronic and Microlife and a speaker for Bayer, Boehringer Ingelheim, Bristol-Myers Squibb/Pfizer, Daiichi Sankyo, Medtronic, Microlife and Roche. Please see the study for all other authors’ relevant financial disclosures.