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AEIOU: Regardless of interruption during AF ablation, apixaban comparable to warfarin for stroke prevention
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CHICAGO — The efficacy and safety of uninterrupted or interrupted apixaban was similar to uninterrupted warfarin for stroke prevention at the time of atrial fibrillation ablation, according to data presented at the Heart Rhythm Society Annual Scientific Sessions.
“Anticoagulation is mandatory before, during and after AF ablation to minimize risk of stroke, but it contributes to bleeding complications. Uninterrupted warfarin has been found to be safer and more effective than interrupted warfarin and bridging. Novel oral anticoagulants given with no or minimal interruption are effective for avoiding stroke with similar or lower risk than warfarin, but apixaban has not been studied specifically,” researcher Matthew R. Reynolds, MD, MSc, from the Lahey Hospital and Medical Center, Burlington, Massachusetts, and Baim Institute for Clinical Research, Boston, said during his presentation.
The prospective, multicenter, randomized AEIOU trial was designed to compare a fully uninterrupted apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) regimen with an interrupted regimen in which the morning dose was withheld the day of the procedure.
All patients had nonvalvular AF and were undergoing planned ablation. They were all treated with apixaban for at least 21 days before the procedure and were dosed according to FDA labeling. The primary efficacy endpoint was nonhemorrhagic stroke and systemic embolism, and the primary safety endpoint was clinically significant bleeding as defined by Bleeding Academic Research Consortium criteria.
Of 300 patients who underwent randomization from 2015 to 2017, 150 patients in the uninterrupted apixaban arm and 145 patients in the interrupted apixaban arm had evaluable data. For comparison of outcomes, the researchers also evaluated a retrospective matched cohort of 295 patients who were treated with uninterrupted warfarin at the same centers from 2011 to 2017.
The rate of the primary efficacy endpoint was low in all groups, with no strokes or systemic embolisms occurring in any of the treatment groups, according to the data. The secondary endpoint of transient ischemic attack occurred in four patients — one each in the uninterrupted and interrupted apixaban groups and two in the warfarin group, Reynolds reported.
The rates of clinically significant bleeding (BARC 2 and higher) were not significantly different, with events occurring in 11.3% of patients treated with uninterrupted apixaban, 9.7% of those treated with interrupted apixaban, 10.5% of all patients treated with apixaban and 9.8% of those treated with uninterrupted warfarin.
Similarly, the rates of major bleeding were 1.3% in the uninterrupted apixaban group, 2.1% in the interrupted apixaban group, 1.7% in the combined apixaban groups and 1.4% in the uninterrupted warfarin group. These differences were also not significant, Reynolds noted.
Although baseline characteristics did not differ between the uninterrupted and interrupted apixaban study arms, left ventricular ejection fraction was higher and BMI was lower in the combined apixaban arms compared with the warfarin study arm.
The researchers also noted differences in procedural characteristics between groups, which were likely attributable to the difference in the time period studied between the warfarin group (2011 to 2017) and the apixaban group (2015 to 2017), according to Reynolds.
“Apixaban, either fully uninterrupted or interrupted by one dose, had similar effectiveness as uninterrupted warfarin at preventing stroke or systemic embolism at the time of AF ablation, with bleeding rates that are similar to warfarin and low rates of major bleeding,” Reynolds said. – by Melissa Foster
Reference:
Reynolds MR. LBCT01-05. Presented at: Heart Rhythm Society Annual Scientific Sessions; May 10-13, 2017; Chicago.
Disclosure: The Baim Institute for Clinical Research sponsored the study with support from Bristol-Myers Squibb and Pfizer. Reynolds reports receiving compensation for services from Biosense Webster, Medtronic, Sanofi Aventis and St. Jude Medical.
Perspective
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Andrew D. Krahn, MD, FHRS
AEIOU weighs in on the whole topic of stroke and bleeding prevention in patients undergoing ablation. In the end, what the trial does, on a very small scale, is look at two ways of managing anticoagulation. The results show that, at least in that number of patients, both strategies are reasonable and there wasn’t much difference in outcomes in that number of patients. The strategies of uninterrupted and interrupted apixaban compared favorably to previous evidence for people who were on uninterrupted warfarin.
The number of strokes was zero, which is great news for patients. From a clinical study perspective, the lack of strokes also means it will be virtually impossible to prove that one treatment is better than the other because they are such rare events. Therefore, until we have higher levels of evidence, the perception is that both strategies are reasonable, even though it’s not really proven. Data from the RE-CIRCUIT trial presented at the American College of Cardiology Scientific Session further support the notion that staying on a novel oral anticoagulant is a reasonable strategy. What we don’t yet have are enough data on those rare, terrible events that people may experience during the procedure.
The take-home message is that it’s reasonable to use both strategies, and it will come down to clinician judgment based on the patient’s bleeding and thrombosis risk.
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