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Updated: Jun 14, 2025

The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Asundexian versus Apixaban in Patients with Atrial Fibrillation
Jonathan P Piccini1, Manesh R Patel1, Jan Steffel1
1From Duke Clinical Research Institute, Duke University School of Medicine (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, S.J.E., F.W.R., J.H.A.), and Duke University Medical Center (J.P.P., M.R.P., R.D.L., W.S.J., J. Harrington, F.W.R., J.H.A.) - both in Durham, NC; Hirslanden Clinic Zurich, Zurich, Switzerland (J.S.); the School of Medicine, Tulane University, New Orleans (K.F.); the University Medical Center, University of Groningen, Groningen (I.C.V.G., M.R.), Radboud University Medical Center, Nijmegen (M.H.), Rijnstate Hospital, Arnhem (M.H.), and the Dutch Network for Cardiovascular Research, Utrecht (M.H.) - all in the Netherlands; Cooper Medical School of Rowan University, Camden (A.M.R.), and Bayer U.S., Whippany (R.C.) - both in New Jersey; the Cardiology Center of Beijing, Anzhen Hospital No. 2, Beijing (C.-S.M.); the Canadian VIGOUR Centre, University of Alberta, Edmonton, and St. Michael's Hospital, Unity Health Toronto, and Peter Munk Cardiac Centre, University Health Network, University of Toronto, Toronto - all in Canada (S.G.G.); the Uppsala Clinical Research Center and the Department of Medical Sciences, Uppsala University, Uppsala, Sweden (J.O.); the Department of Cardiology, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia (C.H.); the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan (M.A.); the School of Cardiology, University of Pisa, and the Cardiology Division, Pisa University Hospital, Pisa (R.D.C.), and Santa Maria della Misericordia Hospital, University of Perugia, Perugia (V.C.) - all in Italy; the Department of Cardiology, University Heart and Vascular Center Hamburg, and the German Center for Cardiovascular Research, Hamburg (P.K.), and Bayer, Wuppertal (C.N., T.V., H.M.) - all in Germany; the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (P.K.), the Faculty of Medicine, National Heart and Lung Institute, Imperial College, London (D.A.G.), the Centre for Health Services and Clinical Research, Faculty of Life and Medical Sciences, University of Hertfordshire, Hatfield (D.A.G.), and the Liverpool Centre for Cardiovascular Science at University of Liverpool and John Moores University and Liverpool Heart and Chest Hospital, Liverpool (G.Y.H.L.) - all in the United Kingdom; the Department of Clinical Medicine, Danish Center for Health Services Research, Aalborg University, Aalborg, Denmark (G.Y.H.L.); and Bayer, São Paulo (J. Hung).
Asundexian, an oral anticoagulant, showed fewer major bleeding events but a higher incidence of stroke or systemic embolism compared to apixaban in atrial fibrillation patients. Further research is needed for stroke prevention efficacy.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Direct-acting oral anticoagulants (DOACs) for atrial fibrillation (AF) stroke prevention risk bleeding.
- Asundexian, a novel Factor XIa inhibitor, aims to reduce bleeding risk.
Purpose of the Study:
- To evaluate if asundexian is non-inferior to apixaban in preventing stroke or systemic embolism.
- To assess if asundexian is superior to apixaban in reducing major bleeding events.
Main Methods:
- Phase 3, international, double-blind trial comparing asundexian (50 mg once daily) to apixaban.
- Randomized 14,810 high-risk AF patients in a 1:1 ratio.
- Primary endpoints: non-inferiority for stroke/systemic embolism, superiority for major bleeding.
Main Results:
- Trial stopped prematurely.
- Asundexian group: 1.3% stroke/systemic embolism; Apixaban group: 0.4% (HR 3.79).
- Asundexian group: 0.2% major bleeding; Apixaban group: 0.7% (HR 0.32).
Conclusions:
- Asundexian showed a higher stroke/systemic embolism incidence than apixaban before premature trial cessation.
- Asundexian demonstrated fewer major bleeding events compared to apixaban.
- The study highlights a potential trade-off between efficacy and safety for asundexian.
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