Reversal of Rivaroxaban and Dabigatran by Prothrombin Complex Concentrate: A Randomized, Placebo-Controlled, Crossover Study in Healthy Subjects

Rivaroxaban and dabigatran are new oral anticoagulants that specifically inhibit factor Xa and thrombin, respectively. Clinical studies on the prevention and treatment of venous and arterial thromboembolism show promising results. A major disadvantage of these anticoagulants is the absence of an ant...

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Bibliographic Details
Published in:Circulation (New York, N.Y.) N.Y.), 2011-10, Vol.124 (14), p.1573-1579
Main Authors: EERENBERG, Elise S, KAMPHUISEN, Pieter W, SIJPKENS, Meertien K, MEIJERS, Joost C, BULLER, Harry R, LEVI, Marcel
Format: Article
Language:English
Subjects:
Adult
Anticoagulants - antagonists & inhibitors
Antidotes - pharmacology
Benzimidazoles - antagonists & inhibitors
beta-Alanine - analogs & derivatives
beta-Alanine - antagonists & inhibitors
Biological and medical sciences
Blood and lymphatic vessels
Blood Coagulation - drug effects
Blood Coagulation Factors - pharmacology
Cardiology. Vascular system
Cardiovascular system
Cross-Over Studies
Dabigatran
Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous
Double-Blind Method
Endopeptidases
Factor Xa Inhibitors
Humans
Male
Medical sciences
Morpholines - antagonists & inhibitors
Partial Thromboplastin Time
Pharmacology. Drug treatments
Prothrombin Time
Rivaroxaban
Thiophenes - antagonists & inhibitors
Thrombin - antagonists & inhibitors
Thrombin Time
Vasodilator agents. Cerebral vasodilators
Young Adult
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Summary:Rivaroxaban and dabigatran are new oral anticoagulants that specifically inhibit factor Xa and thrombin, respectively. Clinical studies on the prevention and treatment of venous and arterial thromboembolism show promising results. A major disadvantage of these anticoagulants is the absence of an antidote in case of serious bleeding or when an emergency intervention needs immediate correction of coagulation. This study evaluated the potential of prothrombin complex concentrate (PCC) to reverse the anticoagulant effect of these drugs. In a randomized, double-blind, placebo-controlled study, 12 healthy male volunteers received rivaroxaban 20 mg twice daily (n=6) or dabigatran 150 mg twice daily (n=6) for 2½ days, followed by either a single bolus of 50 IU/kg PCC (Cofact) or a similar volume of saline. After a washout period, this procedure was repeated with the other anticoagulant treatment. Rivaroxaban induced a significant prolongation of the prothrombin time (15.8±1.3 versus 12.3±0.7 seconds at baseline; P
ISSN:0009-7322
1524-4539
DOI:10.1161/CIRCULATIONAHA.111.029017