Chun Chin Chang1,2,3, Ply Chichareon4,5, Rodrigo Modolo4, Kuniaki Takahashi4, Norihiro Kogame4, Mariusz Tomaniak1, Chao Gao6, Kees-Jan Royaards7, Angel Cequier8, Keith Oldroyd9, Philippe Gabriel Steg10, Christian Hamm11, Peter Jüni12, Marco Valgimigli13, Stephan Windecker13, Yoshinobu Onuma1,14, Rod H Stables15, Robert Jan van Geuns1,6, Patrick W Serruys16. 1. Department of Cardiology, Thoraxcenter, Erasmus University Medical Center, Doctor Molewaterplein 40, GD Rotterdam, Netherlands. 2. Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital, Beitou 11217, Taipei, Taiwan. 3. Institute of Clinical Medicine, National Yang Ming University, Beitou 11221, Taipei, Taiwan. 4. Department of Cardiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands. 5. Division of Cardiology, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Hat Yai 90110, Songkhla, Thailand. 6. Cardiology Department, Radboudumc, Comeniuslaan 4 6525 HP, Nijmegen, the Netherlands. 7. Department of Cardiology, Maasstad Hospital, Maasstadweg 21, 3079 DZ, Rotterdam, Netherlands. 8. Department of Cardiology, Bellvitge University Hospital, IDIBELL, L'Hospitalet de Llobregat 08907, Barcelona, Spain. 9. West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank G81 4DY, UK. 10. Cardiology Department, AP-HP, Hospital, Bichat, 75018 Paris, France. 11. Department of Cardiology, Kerckhoff Heart Center, 61231Bad Nauheim, Germany. 12. Department of Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, M4P 1A6, Canada. 13. Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, 3010 Bern, Switzerland. 14. Cardialysis B.V., 3012 KM Rotterdam, Netherlands. 15. Institute of Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital, Liverpool L14 3PE, UK. 16. National Heart and Lung Institute, Imperial College London, London SW3 6LY, UK.
Abstract
AIMS: The efficacy and safety of continued bivalirudin infusion after percutaneous coronary intervention (PCI) remains uncertain. We sought to investigate the association between post-PCI bivalirudin infusion and the risk of net adverse clinical events (NACE) at 30 days. METHODS AND RESULTS: In the GLOBAL LEADERS study, all patients who received bivalirudin during PCI were categorized according to the use of bivalirudin infusion after the procedure. The primary endpoint of the present analysis was NACE [a composite of all-cause death, any stroke, any myocardial infarction, all revascularization, and bleeding assessed according to the Bleeding Academic Research Consortium (BARC) criteria Type 3 or 5] at 30 days. The key safety endpoint was BARC Type 3 or 5 bleeding and definite stent thrombosis. Of 15 968 patients, 13 870 underwent PCI with the use of bivalirudin. In total, 7148 patients received continued bivalirudin infusion after procedure, while 6722 patients received standard care. After propensity score covariate adjustment, the risk of NACE did not significantly differ between two treatments after PCI [continued bivalirudin infusion vs. no bivalirudin infusion: 3.2% vs. 3.1%, adjusted hazard ratio (aHR) 1.35, 95% confidence interval (CI) 0.99-1.84, P = 0.06] nor the BARC Type 3 or 5 bleeding (0.7% vs. 0.7%, aHR 0.89, 95% CI 0.44-1.79; P = 0.743) and definite stent thrombosis (0.5% vs. 0.3%, aHR 1.71, 95% CI 0.77-3.81, P = 0.189). However, continued bivalirudin infusion was associated with an increased risk of NACE and definite stent thrombosis in ST-elevation myocardial infarction (STEMI) patients. CONCLUSION: In an all-comers population undergoing PCI, there was no significant difference in the risk of NACE at 30 days between continued bivalirudin infusion vs. no bivalirudin infusion after procedure but continued bivalirudin infusion was associated with a higher risk of NACE in STEMI patients when compared with no infusion. Published on behalf of the European Society of Cardiology. All rights reserved.
AIMS: The efficacy and safety of continued bivalirudin infusion after percutaneous coronary intervention (PCI) remains uncertain. We sought to investigate the association between post-PCI bivalirudin infusion and the risk of net adverse clinical events (NACE) at 30 days. METHODS AND RESULTS: In the GLOBAL LEADERS study, all patients who received bivalirudin during PCI were categorized according to the use of bivalirudin infusion after the procedure. The primary endpoint of the present analysis was NACE [a composite of all-cause death, any stroke, any myocardial infarction, all revascularization, and bleeding assessed according to the Bleeding Academic Research Consortium (BARC) criteria Type 3 or 5] at 30 days. The key safety endpoint was BARC Type 3 or 5 bleeding and definite stent thrombosis. Of 15 968 patients, 13 870 underwent PCI with the use of bivalirudin. In total, 7148 patients received continued bivalirudin infusion after procedure, while 6722 patients received standard care. After propensity score covariate adjustment, the risk of NACE did not significantly differ between two treatments after PCI [continued bivalirudin infusion vs. no bivalirudin infusion: 3.2% vs. 3.1%, adjusted hazard ratio (aHR) 1.35, 95% confidence interval (CI) 0.99-1.84, P = 0.06] nor the BARC Type 3 or 5 bleeding (0.7% vs. 0.7%, aHR 0.89, 95% CI 0.44-1.79; P = 0.743) and definite stent thrombosis (0.5% vs. 0.3%, aHR 1.71, 95% CI 0.77-3.81, P = 0.189). However, continued bivalirudin infusion was associated with an increased risk of NACE and definite stent thrombosis in ST-elevation myocardial infarction (STEMI) patients. CONCLUSION: In an all-comers population undergoing PCI, there was no significant difference in the risk of NACE at 30 days between continued bivalirudin infusion vs. no bivalirudin infusion after procedure but continued bivalirudin infusion was associated with a higher risk of NACE in STEMI patients when compared with no infusion. Published on behalf of the European Society of Cardiology. All rights reserved.