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Apixaban compared with parenteral heparin and/or vitamin K antagonist in patients with nonvalvular atrial fibrillation undergoing cardioversion: Rationale and design of the EMANATE trial
Thomas Jefferson Univ, Sidney Kimmel Med Coll, Philadelphia, PA 19107 USA.;Lankenau Med Ctr, Wynnewood, PA USA..
Thomas Jefferson Univ, Philadelphia, PA 19107 USA..
Pfizer, London, England..
Icahn Sch Med Mt Sinai, New York, NY 10029 USA..
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2016 (English)In: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 179, 59-68 p.Article in journal (Refereed) Published
Abstract [en]

Background: Stroke prevention in anticoagulation-nafve patients with atrial fibrillation undergoing cardioversion has not been systematically studied.

Objective: To determine outcomes in anticoagulation-naive patients (defined as those receiving an anticoagulant for <48 hours during the index episode of atrial fibrillation) scheduled for cardioversion.

Methods: This is a randomized, prospective, open-label, real-world study comparing apixaban to heparin plus warfarin. Early image-guided cardioversion is encouraged. For apixaban, the usual dose is 5 mg BID with a dose reduction to 2.5 mg BID if 2 of the following are present: age >80 years, weight <60 kg, or serum creatinine >1.5 mg/dL. If cardioversion is immediate, a single starting dose of 10 mg (or 5 mg if the dose is down-titrated) of apixaban is administered. Cardioversion may be attempted up to 90 days after randomization. Patients are followed up for 30 days after cardioversion or 90 days postrandomization if cardioversion is not performed within that timeframe. Outcomes are stroke, systemic embolization, major bleeds, clinically relevant nonmajor bleeding, and death, all adjudication-blinded.

Statistics: The warfarin-naive cohort from the ARISTOTLE study was considered the closest data set to the patients being recruited into this study. The predicted incidence of stroke, systemic embolism, and major bleeding within 30 days after randomization was approximately 0.75%. To adequately power for a noninferiority trial, approximately 48,000 participants would be needed, a number in excess of feasibility. The figure of 1,500 patients was considered clinically meaningful and achievable.

Place, publisher, year, edition, pages
2016. Vol. 179, 59-68 p.
National Category
Cardiac and Cardiovascular Systems
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URN: urn:nbn:se:uu:diva-305538DOI: 10.1016/j.ahj.2016.06.008ISI: 000383112100007PubMedID: 27595680OAI: oai:DiVA.org:uu-305538DiVA: diva2:1040296
Available from: 2016-10-27 Created: 2016-10-19 Last updated: 2016-10-27Bibliographically approved

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Oldgren, Jonas
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