James D Douketis1, Jeff S Healey2, Martina Brueckmann3, Mandy Fraessdorf4, Alex C Spyropoulos5, Lars Wallentin6, Jonas Oldgren6, Paul Reilly7, Michael D Ezekowitz8, Stuart J Connolly2, Salim Yusuf2, John W Eikelboom2. 1. Department of Medicine, McMaster University, Hamilton, Canada. Electronic address: jdouket@mcmaster.ca. 2. Department of Medicine, McMaster University, Hamilton, Canada; Population Health Research Institute, McMaster University, Hamilton, Canada. 3. Boehringer Ingelheim Pharma GmbH & Co, Ingelheim am Rhein, Germany; Medical Faculty, Mannheim University of Heidelberg, Germany. 4. Boehringer Ingelheim Pharma GmbH & Co, Ingelheim am Rhein, Germany. 5. Hofstra North Shore-Long Island Jewish School of Medicine, Manhasset, NY, USA. 6. Uppsala Clinical Research Centre and Department of Medical Sciences Cardiology, Uppsala University, Sweden. 7. Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, USA. 8. Jefferson Medical College, Wynnewood, PA, USA.
Abstract
BACKGROUND: There is concern about the management of anticoagulated patients with atrial fibrillation (AF) who require an urgent surgery/procedure, especially in those who are receiving a direct oral anticoagulant such as dabigatran. METHODS: We accessed the database from RE-LY, a randomized trial comparing dabigatran (110mg and 150mg twice daily) with warfarin for stroke prevention in AF, to assess patients who had an urgent and elective surgery/procedure. We compared the risk for thromboembolism, major bleeding and mortality according to treatment allocation (dabigatran 110mg or 150mg, or warfarin) or surgery/procedure type (urgent or elective). Outcomes were assessed from day-7 to day 30 after a surgery/procedure. RESULTS:353 patients (2.0% of study population) had an urgent surgery/procedure and 4168 patients (23.1% of study population) had an elective surgery/procedure. In patients on dabigatran 110mg, dabigatran 150mg and warfarin who had an urgent surgery/procedure: rates of thromboembolism were 16.1%, 7.4%, and 10.5%; rates of major bleeding were 17.0%, 17.6%, and 22.9%; rates of mortality were 6.3%, 1.5%, and 2.9%, respectively (P>0.50 for all comparisons). Rates of these outcomes were multi-fold higher in patients having an urgent rather than an elective surgery/procedure (P<0.5 for all comparisons). CONCLUSION: In anticoagulated patients with atrial fibrillation who require an urgent surgery/procedure, therisks for thromboembolism, major bleeding and mortality did not differ depending on treatment with dabigatran or warfarin, but rates of these outcomes were multi-fold higher than in patients having an elective surgery/procedure.
RCT Entities:
BACKGROUND: There is concern about the management of anticoagulated patients with atrial fibrillation (AF) who require an urgent surgery/procedure, especially in those who are receiving a direct oral anticoagulant such as dabigatran. METHODS: We accessed the database from RE-LY, a randomized trial comparing dabigatran (110mg and 150mg twice daily) with warfarin for stroke prevention in AF, to assess patients who had an urgent and elective surgery/procedure. We compared the risk for thromboembolism, major bleeding and mortality according to treatment allocation (dabigatran 110mg or 150mg, or warfarin) or surgery/procedure type (urgent or elective). Outcomes were assessed from day-7 to day 30 after a surgery/procedure. RESULTS: 353 patients (2.0% of study population) had an urgent surgery/procedure and 4168 patients (23.1% of study population) had an elective surgery/procedure. In patients on dabigatran 110mg, dabigatran 150mg and warfarin who had an urgent surgery/procedure: rates of thromboembolism were 16.1%, 7.4%, and 10.5%; rates of major bleeding were 17.0%, 17.6%, and 22.9%; rates of mortality were 6.3%, 1.5%, and 2.9%, respectively (P>0.50 for all comparisons). Rates of these outcomes were multi-fold higher in patients having an urgent rather than an elective surgery/procedure (P<0.5 for all comparisons). CONCLUSION: In anticoagulated patients with atrial fibrillation who require an urgent surgery/procedure, the risks for thromboembolism, major bleeding and mortality did not differ depending on treatment with dabigatran or warfarin, but rates of these outcomes were multi-fold higher than in patients having an elective surgery/procedure.
Authors: Yin Ge; Andrew C T Ha; Clare L Atzema; Husam M Abdel-Qadir; Jiming Fang; Peter C Austin; Duminda N Wijeysundera; Douglas S Lee Journal: J Am Heart Assoc Date: 2017-12-12 Impact factor: 5.501
Authors: Radoslaw Litwinowicz; Janusz Konstanty-Kalandyk; Tadeusz Goralczyk; Krzysztof Bartus; Piotr Mazur Journal: J Thromb Thrombolysis Date: 2018-01 Impact factor: 2.300
Authors: Milan R Vosko; Christof Bocksrucker; Rafał Drwiła; Petr Dulíček; Tomas Hauer; Johannes Mutzenbach; Christoph J Schlimp; David Špinler; Thomas Wolf; Daša Zugwitz Journal: J Thromb Thrombolysis Date: 2017-04 Impact factor: 2.300