Change search
ReferencesLink to record
Permanent link

Direct link
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..
Show others and affiliations
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
URN: urn:nbn:se:uu:diva-305538DOI: 10.1016/j.ahj.2016.06.008ISI: 000383112100007PubMedID: 27595680OAI: diva2:1040296
Available from: 2016-10-27 Created: 2016-10-19 Last updated: 2016-10-27Bibliographically approved

Open Access in DiVA

fulltext(504 kB)31 downloads
File information
File name FULLTEXT01.pdfFile size 504 kBChecksum SHA-512
Type fulltextMimetype application/pdf

Other links

Publisher's full textPubMed

Search in DiVA

By author/editor
Oldgren, Jonas
By organisation
CardiologyUCR-Uppsala Clinical Research Center
In the same journal
American Heart Journal
Cardiac and Cardiovascular Systems

Search outside of DiVA

GoogleGoogle Scholar
Total: 31 downloads
The number of downloads is the sum of all downloads of full texts. It may include eg previous versions that are now no longer available

Altmetric score

Total: 111 hits
ReferencesLink to record
Permanent link

Direct link