Heribert Schunkert1,2, Andreas Boening3, Moritz von Scheidt1,2, Clarissa Lanig1, Friederike Gusmini1, Antoinette de Waha1, Constantin Kuna1, Andreas Fach4, Christina Grothusen5, Martin Oberhoffer6, Christoph Knosalla7,8, Thomas Walther9, Bernhard C Danner10, Martin Misfeld11, Uwe Zeymer12, Gerhard Wimmer-Greinecker13, Matthias Siepe14, Herko Grubitzsch15, Alexander Joost16, Andreas Schaefer17, Lenard Conradi17, Jochen Cremer5, Christian Hamm18,19, Rüdiger Lange1,2, Peter W Radke20, Rainer Schulz21, Günther Laufer22, Philippe Grieshaber3, Philip Pader4, Tim Attmann5, Michael Schmoeckel6, Alexander Meyer7,8, Tibor Ziegelhöffer9, Rainer Hambrecht4, Adnan Kastrati1,2, Sigrid E Sandner22. 1. Department of Cardiology, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse 36, Munich, Germany. 2. DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany. 3. Department of Cardiovascular Surgery, Justus-Liebig University Gießen, Ludwigstraße 23, Gießen, Germany. 4. Department of Cardiology and Angiology, Klinikum Links der Weser, Senator-Weßling-Straße 1, Bremen, Germany. 5. Department of Cardiovascular Surgery, University Hospital of Schleswig-Holstein, Arnold-Heller-Straße 3, Kiel, Germany. 6. Department of Cardiac Surgery, Asklepios Klinik St. Georg, Lohmühlenstraße 5, Hamburg, Germany. 7. Department of Cardiothoracic and Vascular Surgery, German Heart Institute Berlin, Augustenburger Platz 1, Berlin, Germany. 8. DZHK (German Center for Cardiovascular Research), partner site Berlin, Berlin, Germany. 9. Department of Cardiac Surgery, Kerckhoff Heart and Thorax Center, Benekestraße 2-8, Bad Nauheim, Germany. 10. Department of Thoracic and Cardiovascular Surgery, University Medical Center, Robert-Koch-Straße 40, Göttingen, Germany. 11. University Department of Cardiac Surgery, Leipzig Heart Center, Strümpellstraße 39, Leipzig, Germany. 12. Klinikum Ludwigshafen and Institut für Herzinfarktforschung Ludwigshafen, Bremserstraße 79, Ludwigshafen, Germany. 13. Department for Cardiothoracic Surgery, Heart and Vessel Center Bad Bevensen, Römstedter Straße 25, Bad Bevensen, Germany. 14. Department of Cardiovascular Surgery, Heart Centre Freiburg University, University of Freiburg, Hugstetter Straße 55, Freiburg, Germany. 15. Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, Charitéplatz 1, Berlin, Germany. 16. Department of Cardiology, Angiology and Intensive Care Medicine, Medical Clinic II, University Hospital Schleswig-Holstein, Ratzeburger Allee 160, Lübeck, Germany. 17. Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany. 18. Justus-Liebig University Gießen, Kerckhoff Campus, Ludwigstraße 23, Gießen, Germany. 19. DZHK (German Center for Cardiovascular Research), partner site Rhein-Main, Rhein-Main, Germany. 20. Department of Internal Medicine-Cardiology, Schön Klinik Neustadt SE & Co. KG, Am Kiebitzberg 10, Neustadt, Germany. 21. Institute of Physiology, Justus-Liebig University Gießen, Aulweg 129, Gießen, Germany. 22. Division of Cardiac Surgery, Medical University Vienna, Spitalgasse 23, Wien, Austria.
Abstract
AIMS: The antiplatelet treatment strategy providing optimal balance between thrombotic and bleeding risks in patients undergoing coronary artery bypass grafting (CABG) is unclear. We prospectively compared the efficacy of ticagrelor and aspirin after CABG. METHODS AND RESULTS: We randomly assigned in double-blind fashion patients scheduled for CABG to either ticagrelor 90 mg twice daily or 100 mg aspirin (1:1) once daily. The primary outcome was the composite of cardiovascular death, myocardial infarction (MI), repeat revascularization, and stroke 12 months after CABG. The main safety endpoint was based on the Bleeding Academic Research Consortium classification, defined as BARC ≥4 for periprocedural and hospital stay-related bleedings and BARC ≥3 for post-discharge bleedings. The study was prematurely halted after recruitment of 1859 out of 3850 planned patients. Twelve months after CABG, the primary endpoint occurred in 86 out of 931 patients (9.7%) in the ticagrelor group and in 73 out of 928 patients (8.2%) in the aspirin group [hazard ratio 1.19; 95% confidence interval (CI) 0.87-1.62; P = 0.28]. All-cause mortality (ticagrelor 2.5% vs. aspirin 2.6%, hazard ratio 0.96, CI 0.53-1.72; P = 0.89), cardiovascular death (ticagrelor 1.2% vs. aspirin 1.4%, hazard ratio 0.85, CI 0.38-1.89; P = 0.68), MI (ticagrelor 2.1% vs. aspirin 3.4%, hazard ratio 0.63, CI 0.36-1.12, P = 0.12), and stroke (ticagrelor 3.1% vs. 2.6%, hazard ratio 1.21, CI 0.70-2.08; P = 0.49), showed no significant difference between the ticagrelor and aspirin group. The main safety endpoint was also not significantly different (ticagrelor 3.7% vs. aspirin 3.2%, hazard ratio 1.17, CI 0.71-1.92; P = 0.53). CONCLUSION: In this prematurely terminated and thus underpowered randomized trial of ticagrelor vs. aspirin in patients after CABG no significant differences in major cardiovascular events or major bleeding could be demonstrated. CLINICALTRIALS.GOV IDENTIFIER: NCT01755520. Published on behalf of the European Society of Cardiology. All rights reserved.
RCT Entities:
AIMS: The antiplatelet treatment strategy providing optimal balance between thrombotic and bleeding risks in patients undergoing coronary artery bypass grafting (CABG) is unclear. We prospectively compared the efficacy of ticagrelor and aspirin after CABG. METHODS AND RESULTS: We randomly assigned in double-blind fashion patients scheduled for CABG to either ticagrelor 90 mg twice daily or 100 mg aspirin (1:1) once daily. The primary outcome was the composite of cardiovascular death, myocardial infarction (MI), repeat revascularization, and stroke 12 months after CABG. The main safety endpoint was based on the Bleeding Academic Research Consortium classification, defined as BARC ≥4 for periprocedural and hospital stay-related bleedings and BARC ≥3 for post-discharge bleedings. The study was prematurely halted after recruitment of 1859 out of 3850 planned patients. Twelve months after CABG, the primary endpoint occurred in 86 out of 931 patients (9.7%) in the ticagrelor group and in 73 out of 928 patients (8.2%) in the aspirin group [hazard ratio 1.19; 95% confidence interval (CI) 0.87-1.62; P = 0.28]. All-cause mortality (ticagrelor 2.5% vs. aspirin 2.6%, hazard ratio 0.96, CI 0.53-1.72; P = 0.89), cardiovascular death (ticagrelor 1.2% vs. aspirin 1.4%, hazard ratio 0.85, CI 0.38-1.89; P = 0.68), MI (ticagrelor 2.1% vs. aspirin 3.4%, hazard ratio 0.63, CI 0.36-1.12, P = 0.12), and stroke (ticagrelor 3.1% vs. 2.6%, hazard ratio 1.21, CI 0.70-2.08; P = 0.49), showed no significant difference between the ticagrelor and aspirin group. The main safety endpoint was also not significantly different (ticagrelor 3.7% vs. aspirin 3.2%, hazard ratio 1.17, CI 0.71-1.92; P = 0.53). CONCLUSION: In this prematurely terminated and thus underpowered randomized trial of ticagrelor vs. aspirin in patients after CABG no significant differences in major cardiovascular events or major bleeding could be demonstrated. CLINICALTRIALS.GOV IDENTIFIER: NCT01755520. Published on behalf of the European Society of Cardiology. All rights reserved.
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