Idarucizumab for Dabigatran Reversal — Full Cohort Analysis

作者: Charles V. Pollack , Paul A. Reilly , Joanne van Ryn , John W. Eikelboom , Stephan Glund

DOI: 10.1056/NEJMOA1707278

关键词:

摘要: BackgroundIdarucizumab, a monoclonal antibody fragment, was developed to reverse the anticoagulant effect of dabigatran. MethodsWe performed multicenter, prospective, open-label study determine whether 5 g intravenous idarucizumab would be able dabigatran in patients who had uncontrolled bleeding (group A) or were about undergo an urgent procedure B). The primary end point maximum percentage reversal within 4 hours after administration idarucizumab, on basis diluted thrombin time ecarin clotting time. Secondary points included restoration hemostasis and safety measures. ResultsA total 503 enrolled: 301 group A, 202 B. median 100% (95% confidence interval, 100 100), either In 137 (45.5%) presented ...

参考文章(18)
Charles V. Pollack, Paul A. Reilly, John Eikelboom, Stephan Glund, Peter Verhamme, Richard A. Bernstein, Robert Dubiel, Menno V. Huisman, Elaine M. Hylek, Pieter W. Kamphuisen, Jörg Kreuzer, Jerrold H. Levy, Frank W. Sellke, Joachim Stangier, Thorsten Steiner, Bushi Wang, Chak-Wah Kam, Jeffrey I. Weitz, Idarucizumab for Dabigatran Reversal The New England Journal of Medicine. ,vol. 373, pp. 511- 520 ,(2015) , 10.1056/NEJMOA1502000
Paul A. Reilly, Thorsten Lehr, Sebastian Haertter, Stuart J. Connolly, Salim Yusuf, John W. Eikelboom, Michael D. Ezekowitz, Gerhard Nehmiz, Susan Wang, Lars Wallentin, The Effect of Dabigatran Plasma Concentrations and Patient Characteristics on the Frequency of Ischemic Stroke and Major Bleeding in Atrial Fibrillation Patients Journal of the American College of Cardiology. ,vol. 63, pp. 321- 328 ,(2014) , 10.1016/J.JACC.2013.07.104
Hein Heidbuchel, Peter Verhamme, Marco Alings, Matthias Antz, Hans-Christoph Diener, Werner Hacke, Jonas Oldgren, Peter Sinnaeve, A John Camm, Paulus Kirchhof, Advisors:, Azhar Ahmad, Jutta Heinrich-Nols, Susanne Hess, Markus Müller, Felix Münzel, Markus Schwertfeger, Martin Van Eickels, Isabelle Richard-Lordereau, Gregory YH Lip, Chern-En Chiang, Jonathan Piccini, Tatjana Potpara, Laurent Fauchier, Deirdre Lane, Alvaro Avezum, Torben Bjerregaard Larsen, Guiseppe Boriani, Vanessa Roldan-Schilling, Bulent Gorenek, Irene Savelieva, None, Updated European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist anticoagulants in patients with non-valvular atrial fibrillation. Europace. ,vol. 17, pp. 1467- 1507 ,(2015) , 10.1093/EUROPACE/EUV309
Felix Schiele, Joanne van Ryn, Keith Canada, Corey Newsome, Eliud Sepulveda, John Park, Herbert Nar, Tobias Litzenburger, None, A specific antidote for dabigatran: functional and structural characterization. Blood. ,vol. 121, pp. 3554- 3562 ,(2013) , 10.1182/BLOOD-2012-11-468207
Joachim Stangier, Martin Feuring, Using the HEMOCLOT direct thrombin inhibitor assay to determine plasma concentrations of dabigatran Blood Coagulation & Fibrinolysis. ,vol. 23, pp. 138- 143 ,(2012) , 10.1097/MBC.0B013E32834F1B0C
Viktoria Moschetti, Stephen Norris, Joachim Stangier, Michael Schmohl, Joanne van Ryn, Benjamin Lang, Steven Ramael, Paul Reilly, Stephan Glund, A randomised study in healthy volunteers to investigate the safety, tolerability and pharmacokinetics of idarucizumab, a specific antidote to dabigatran Thrombosis and Haemostasis. ,vol. 113, pp. 943- 951 ,(2015) , 10.1160/TH14-12-1080
S. SCHULMAN, U. ANGERÅS, D. BERGQVIST, B. ERIKSSON, M. R. LASSEN, W. FISHER, , Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients. Journal of Thrombosis and Haemostasis. ,vol. 8, pp. 202- 204 ,(2010) , 10.1111/J.1538-7836.2009.03678.X
Ravi Sarode, Truman J. Milling, Majed A. Refaai, Antoinette Mangione, Astrid Schneider, Billie L. Durn, Joshua N. Goldstein, Efficacy and Safety of a 4-Factor Prothrombin Complex Concentrate in Patients on Vitamin K Antagonists Presenting With Major Bleeding Circulation. ,vol. 128, pp. 1234- 1243 ,(2013) , 10.1161/CIRCULATIONAHA.113.002283
Charles V Pollack Jr, Paul A Reilly, Richard Bernstein, Robert Dubiel, John Eikelboom, Stephan Glund, Menno V Huisman, Elaine Hylek, Chak-Wah Kam, Pieter W Kamphuisen, Joerg Kreuzer, Jerrold H Levy, Frank Sellke, Joachim Stangier, Thorsten Steiner, Bushi Wang, Jeffrey I Weitz, Design and rationale for RE-VERSE AD: A phase 3 study of idarucizumab, a specific reversal agent for dabigatran Thrombosis and Haemostasis. ,vol. 114, pp. 198- 205 ,(2015) , 10.1160/TH15-03-0192