Periprocedural Bleeding and Thromboembolic Events With Dabigatran Compared With Warfarin: Results From the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) Randomized Trial

Dabigatran reduces ischemic stroke in comparison with warfarin; however, given the lack of antidote, there is concern that it might increase bleeding when surgery or invasive procedures are required. The current analysis was undertaken to compare the periprocedural bleeding risk of patients in the R...

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Published inCirculation (New York, N.Y.) Vol. 126; no. 3; pp. 343 - 348
Main Authors HEALEY, Jeff S, EIKELBOOM, John, CONNOLLY, Stuart J, YUSUF, Salim, EZEKOWITZ, Michael, DOUKETIS, James, WALLENTIN, Lars, OLDGREN, Jonas, YANG, Sean, THEMELES, Ellison, HEIDBUCHLE, Hein, AVEZUM, Alvaro, REILLY, Paul
Format Journal Article
LanguageEnglish
Published Hagerstown, MD Lippincott Williams & Wilkins 17.07.2012
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Abstract Dabigatran reduces ischemic stroke in comparison with warfarin; however, given the lack of antidote, there is concern that it might increase bleeding when surgery or invasive procedures are required. The current analysis was undertaken to compare the periprocedural bleeding risk of patients in the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial treated with dabigatran and warfarin. Bleeding rates were evaluated from 7 days before until 30 days after invasive procedures, considering only the first procedure for each patient. A total of 4591 patients underwent at least 1 invasive procedure: 24.7% of patients received dabigatran 110 mg, 25.4% received dabigatran 150 mg, and 25.9% received warfarin, P=0.34. Procedures included: pacemaker/defibrillator insertion (10.3%), dental procedures (10.0%), diagnostic procedures (10.0%), cataract removal (9.3%), colonoscopy (8.6%), and joint replacement (6.2%). Among patients assigned to either dabigatran dose, the last dose of study drug was given 49 (35-85) hours before the procedure on comparison with 114 (87-144) hours in patients receiving warfarin, P<0.001. There was no significant difference in the rates of periprocedural major bleeding between patients receiving dabigatran 110 mg (3.8%) or dabigatran 150 mg (5.1%) or warfarin (4.6%); dabigatran 110 mg versus warfarin: relative risk, 0.83; 95% CI, 0.59 to 1.17; P=0.28; dabigatran 150 mg versus warfarin: relative risk, 1.09; 95% CI, 0.80 to 1.49; P=0.58. Among patients having urgent surgery, major bleeding occurred in 17.8% with dabigatran 110 mg, 17.7% with dabigatran 150 mg, and 21.6% with warfarin: dabigatran 110 mg; relative risk, 0.82; 95% CI, 0.48 to 1.41; P=0.47; dabigatran 150 mg: relative risk, 0.82; 95% CI, 0.50 to 1.35; P=0.44. Dabigatran and warfarin were associated with similar rates of periprocedural bleeding, including patients having urgent surgery. Dabigatran facilitated a shorter interruption of oral anticoagulation. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00262600.
AbstractList BACKGROUNDDabigatran reduces ischemic stroke in comparison with warfarin; however, given the lack of antidote, there is concern that it might increase bleeding when surgery or invasive procedures are required.METHODS AND RESULTSThe current analysis was undertaken to compare the periprocedural bleeding risk of patients in the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial treated with dabigatran and warfarin. Bleeding rates were evaluated from 7 days before until 30 days after invasive procedures, considering only the first procedure for each patient. A total of 4591 patients underwent at least 1 invasive procedure: 24.7% of patients received dabigatran 110 mg, 25.4% received dabigatran 150 mg, and 25.9% received warfarin, P=0.34. Procedures included: pacemaker/defibrillator insertion (10.3%), dental procedures (10.0%), diagnostic procedures (10.0%), cataract removal (9.3%), colonoscopy (8.6%), and joint replacement (6.2%). Among patients assigned to either dabigatran dose, the last dose of study drug was given 49 (35-85) hours before the procedure on comparison with 114 (87-144) hours in patients receiving warfarin, P<0.001. There was no significant difference in the rates of periprocedural major bleeding between patients receiving dabigatran 110 mg (3.8%) or dabigatran 150 mg (5.1%) or warfarin (4.6%); dabigatran 110 mg versus warfarin: relative risk, 0.83; 95% CI, 0.59 to 1.17; P=0.28; dabigatran 150 mg versus warfarin: relative risk, 1.09; 95% CI, 0.80 to 1.49; P=0.58. Among patients having urgent surgery, major bleeding occurred in 17.8% with dabigatran 110 mg, 17.7% with dabigatran 150 mg, and 21.6% with warfarin: dabigatran 110 mg; relative risk, 0.82; 95% CI, 0.48 to 1.41; P=0.47; dabigatran 150 mg: relative risk, 0.82; 95% CI, 0.50 to 1.35; P=0.44.CONCLUSIONSDabigatran and warfarin were associated with similar rates of periprocedural bleeding, including patients having urgent surgery. Dabigatran facilitated a shorter interruption of oral anticoagulation.CLINICAL TRIAL REGISTRATIONURL: http://www.clinicaltrials.gov. Unique identifier: NCT00262600.
Dabigatran reduces ischemic stroke in comparison with warfarin; however, given the lack of antidote, there is concern that it might increase bleeding when surgery or invasive procedures are required. The current analysis was undertaken to compare the periprocedural bleeding risk of patients in the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial treated with dabigatran and warfarin. Bleeding rates were evaluated from 7 days before until 30 days after invasive procedures, considering only the first procedure for each patient. A total of 4591 patients underwent at least 1 invasive procedure: 24.7% of patients received dabigatran 110 mg, 25.4% received dabigatran 150 mg, and 25.9% received warfarin, P=0.34. Procedures included: pacemaker/defibrillator insertion (10.3%), dental procedures (10.0%), diagnostic procedures (10.0%), cataract removal (9.3%), colonoscopy (8.6%), and joint replacement (6.2%). Among patients assigned to either dabigatran dose, the last dose of study drug was given 49 (35-85) hours before the procedure on comparison with 114 (87-144) hours in patients receiving warfarin, P<0.001. There was no significant difference in the rates of periprocedural major bleeding between patients receiving dabigatran 110 mg (3.8%) or dabigatran 150 mg (5.1%) or warfarin (4.6%); dabigatran 110 mg versus warfarin: relative risk, 0.83; 95% CI, 0.59 to 1.17; P=0.28; dabigatran 150 mg versus warfarin: relative risk, 1.09; 95% CI, 0.80 to 1.49; P=0.58. Among patients having urgent surgery, major bleeding occurred in 17.8% with dabigatran 110 mg, 17.7% with dabigatran 150 mg, and 21.6% with warfarin: dabigatran 110 mg; relative risk, 0.82; 95% CI, 0.48 to 1.41; P=0.47; dabigatran 150 mg: relative risk, 0.82; 95% CI, 0.50 to 1.35; P=0.44. Dabigatran and warfarin were associated with similar rates of periprocedural bleeding, including patients having urgent surgery. Dabigatran facilitated a shorter interruption of oral anticoagulation. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00262600.
Background-Dabigatran reduces ischemic stroke in comparison with warfarin; however, given the lack of antidote, there is concern that it might increase bleeding when surgery or invasive procedures are required. Methods and Results-The current analysis was undertaken to compare the periprocedural bleeding risk of patients in the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial treated with dabigatran and warfarin. Bleeding rates were evaluated from 7 days before until 30 days after invasive procedures, considering only the first procedure for each patient. A total of 4591 patients underwent at least 1 invasive procedure: 24.7% of patients received dabigatran 110 mg, 25.4% received dabigatran 150 mg, and 25.9% received warfarin, P=0.34. Procedures included: pacemaker/defibrillator insertion (10.3%), dental procedures (10.0%), diagnostic procedures (10.0%), cataract removal (9.3%), colonoscopy (8.6%), and joint replacement (6.2%). Among patients assigned to either dabigatran dose, the last dose of study drug was given 49 (35-85) hours before the procedure on comparison with 114 (87-144) hours in patients receiving warfarin, P&lt;0.001. There was no significant difference in the rates of periprocedural major bleeding between patients receiving dabigatran 110 mg (3.8%) or dabigatran 150 mg (5.1%) or warfarin (4.6%); dabigatran 110 mg versus warfarin: relative risk, 0.83; 95% CI, 0.59 to 1.17; P=0.28; dabigatran 150 mg versus warfarin: relative risk, 1.09; 95% CI, 0.80 to 1.49; P=0.58. Among patients having urgent surgery, major bleeding occurred in 17.8% with dabigatran 110 mg, 17.7% with dabigatran 150 mg, and 21.6% with warfarin: dabigatran 110 mg; relative risk, 0.82; 95% CI, 0.48 to 1.41; P=0.47; dabigatran 150 mg: relative risk, 0.82; 95% CI, 0.50 to 1.35; P=0.44. Conclusions-Dabigatran and warfarin were associated with similar rates of periprocedural bleeding, including patients having urgent surgery. Dabigatran facilitated a shorter interruption of oral anticoagulation.
Author DOUKETIS, James
WALLENTIN, Lars
EIKELBOOM, John
YANG, Sean
THEMELES, Ellison
AVEZUM, Alvaro
OLDGREN, Jonas
REILLY, Paul
CONNOLLY, Stuart J
HEIDBUCHLE, Hein
HEALEY, Jeff S
EZEKOWITZ, Michael
YUSUF, Salim
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10.1016/j.ahj.2009.02.005
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Issue 3
Keywords Arrhythmia
Coumarine derivatives
Thrombin
Cardiovascular disease
Anticoagulant
Dabigatran
Antithrombin
Hemorrhage
Vascular disease
Prevention
Antivitamin K
Heart disease
Surgery
Antithrombotic agent
anticoagulants
Thromboembolism
Cerebrovascular disease
Nervous system diseases
Stroke
Warfarin
Serine endopeptidases
Enzyme
Atrial fibrillation
Enzyme inhibitor
Thrombosis
Excitability disorder
Embolism
Cerebral disorder
Peptidases
perioperative
Treatment
Central nervous system disease
Hydrolases
stroke prevention
Language English
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PublicationTitle Circulation (New York, N.Y.)
PublicationTitleAlternate Circulation
PublicationYear 2012
Publisher Lippincott Williams & Wilkins
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References Circulation. 2012 Sep 4;126(10):e160
23509038 - Circulation. 2013 Mar 19;127(11):e505
23509037 - Circulation. 2013 Mar 19;127(11):e504
22700855 - Circulation. 2012 Jul 17;126(3):255-7
23646374 - Circulation. 2013 Mar 19;127(11):e506
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Snippet Dabigatran reduces ischemic stroke in comparison with warfarin; however, given the lack of antidote, there is concern that it might increase bleeding when...
BACKGROUNDDabigatran reduces ischemic stroke in comparison with warfarin; however, given the lack of antidote, there is concern that it might increase bleeding...
Background-Dabigatran reduces ischemic stroke in comparison with warfarin; however, given the lack of antidote, there is concern that it might increase...
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StartPage 343
SubjectTerms Aged
Aged, 80 and over
anticoagulants
Anticoagulants - administration & dosage
Anticoagulants - adverse effects
atrial fibrillation
Benzimidazoles - administration & dosage
Benzimidazoles - adverse effects
beta-Alanine - administration & dosage
beta-Alanine - adverse effects
beta-Alanine - analogs & derivatives
Biological and medical sciences
Blood and lymphatic vessels
Blood Loss, Surgical - prevention & control
Blood. Blood coagulation. Reticuloendothelial system
Brain Ischemia - prevention & control
Cardiac Pacing, Artificial - adverse effects
Cardiology. Vascular system
Cataract Extraction - adverse effects
Dabigatran
Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous
Female
Follow-Up Studies
Hemorrhage - chemically induced
Hemorrhage - epidemiology
Hemorrhage - prevention & control
Humans
Incidence
Male
Medical sciences
Middle Aged
perioperative
Pharmacology. Drug treatments
Postoperative Complications - epidemiology
Postoperative Complications - prevention & control
Risk Factors
Stroke - prevention & control
stroke prevention
surgery
Thromboembolism - drug therapy
Thromboembolism - epidemiology
Warfarin - administration & dosage
Warfarin - adverse effects
Title Periprocedural Bleeding and Thromboembolic Events With Dabigatran Compared With Warfarin: Results From the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) Randomized Trial
URI https://www.ncbi.nlm.nih.gov/pubmed/22700854
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Volume 126
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