Ply Chichareon1, Rodrigo Modolo2, Norihiro Kogame3, Kuniaki Takahashi3, Chun-Chin Chang4, Mariusz Tomaniak5, Roberto Botelho6, Eric Eeckhout7, Sjoerd Hofma8, Diana Trendafilova-Lazarova9, Zsolt Kőszegi10, Andres Iñiguez11, Joanna J Wykrzykowska3, Jan J Piek3, Scot Garg12, Christian Hamm13, Philippe Gabriel Steg14, Peter Jüni15, Pascal Vranckx16, Marco Valgimigli17, Stephan Windecker17, Yoshinobu Onuma18, Patrick W Serruys19. 1. Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Meibergdreef 9, Amsterdam, the Netherlands; Cardiology Unit, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand. 2. Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Meibergdreef 9, Amsterdam, the Netherlands; Department of Internal Medicine, Cardiology Division. University of Campinas (UNICAMP). Campinas, Brazil. 3. Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Meibergdreef 9, Amsterdam, the Netherlands. 4. Erasmus Medical Center, Erasmus University, Rotterdam, the Netherlands. 5. Erasmus Medical Center, Erasmus University, Rotterdam, the Netherlands; First Department of Cardiology, Medical University of Warsaw, Warsaw, Poland. 6. CT / Instituto Do Coracao Do Triangulo Mineiro, Uberlandia, Brazil. 7. Department of Cardiology, Lausanne University Hospital, Switzerland. 8. The Department of Cardiology, Medical Center Leeuwarden, Leeuwarden, the Netherlands. 9. "St. Ekaterina" University Hospital, Sofia, Bulgaria. 10. Jósa András Szabolcs-Szatmár-Bereg County Hospitals and University Teaching Hospital, Nyíregyháza, Hungary. 11. Cardiology Department. Hospital Universitario Álvaro Cunqueiro, Vigo, Spain. 12. East Lancashire Hospitals NHS Trust, Blackburn, Lancashire, United Kingdom. 13. Kerckhoff Heart Center, Campus University of Giessen, Bad Nauheim, Germany. 14. Université Paris-Diderot, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, INSERM U-1148, FACT (French Alliance for Cardiovascular Trials), Paris, France; National Heart and Lung Institute, Royal Brompton Hospital, Imperial College, London, United Kingdom. 15. Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Department of Medicine, University of Toronto, Toronto, Canada. 16. Jessa Ziekenhuis, Faculty of Medicine and Life Sciences at the Hasselt University, Hasselt, Belgium. 17. Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland. 18. Department of Cardiology, National University of Ireland Galway, Galway, Ireland. 19. Department of Cardiology, National University of Ireland Galway, Galway, Ireland; NHLI, Imperial College London, London, United Kingdom. Electronic address: patrick.w.j.c.serruys@gmail.com.
Abstract
BACKGROUND AND AIMS: Diabetes has been well recognized as a strong predictor for adverse outcomes after percutaneous coronary intervention (PCI), however, studies in the era of drug-eluting stent and potent P2Y12 inhibitors have shown conflicting results. We aimed to assess ischemic and bleeding outcomes after contemporary PCI according to diabetic status. METHODS: We studied 15,957 patients undergoing PCI for stable or acute coronary syndrome in the GLOBAL LEADERS study with known baseline diabetic status. The primary endpoint was all-cause death or new Q-wave myocardial infarction at 2 years. The secondary safety endpoint was major bleeding defined as bleeding academic research consortium (BARC) type 3 or 5. RESULTS: A quarter of the study cohort were diabetic (4038/15,957), and these patients had a significantly higher risk of primary endpoint at 2 years compared to non-diabetics (adjusted hazard ratio [HR] 1.38; 95% confidence interval [CI] 1.17-1.63). The difference was driven by a significantly higher risk of all-cause mortality at 2 years in diabetics (adjusted HR 1.47, 95% CI 1.22-1.78). The risk of BARC 3 or 5 bleeding was comparable between the two groups (adjusted HR 1.09, 95% CI 0.86-1.39). The antiplatelet strategy (experimental versus reference strategy) had no significant effect on the rates of primary endpoint and secondary safety endpoint at 2 years in patients with and without diabetes. CONCLUSIONS:Diabetic patients had higher risk of ischemic events after PCI than non-diabetic patients, whilst bleeding risk was comparable. The outcomes of diabetic patients following PCI were not affected by the two different antiplatelet strategies.
RCT Entities:
BACKGROUND AND AIMS: Diabetes has been well recognized as a strong predictor for adverse outcomes after percutaneous coronary intervention (PCI), however, studies in the era of drug-eluting stent and potent P2Y12 inhibitors have shown conflicting results. We aimed to assess ischemic and bleeding outcomes after contemporary PCI according to diabetic status. METHODS: We studied 15,957 patients undergoing PCI for stable or acute coronary syndrome in the GLOBAL LEADERS study with known baseline diabetic status. The primary endpoint was all-cause death or new Q-wave myocardial infarction at 2 years. The secondary safety endpoint was major bleeding defined as bleeding academic research consortium (BARC) type 3 or 5. RESULTS: A quarter of the study cohort were diabetic (4038/15,957), and these patients had a significantly higher risk of primary endpoint at 2 years compared to non-diabetics (adjusted hazard ratio [HR] 1.38; 95% confidence interval [CI] 1.17-1.63). The difference was driven by a significantly higher risk of all-cause mortality at 2 years in diabetics (adjusted HR 1.47, 95% CI 1.22-1.78). The risk of BARC 3 or 5 bleeding was comparable between the two groups (adjusted HR 1.09, 95% CI 0.86-1.39). The antiplatelet strategy (experimental versus reference strategy) had no significant effect on the rates of primary endpoint and secondary safety endpoint at 2 years in patients with and without diabetes. CONCLUSIONS:Diabeticpatients had higher risk of ischemic events after PCI than non-diabeticpatients, whilst bleeding risk was comparable. The outcomes of diabeticpatients following PCI were not affected by the two different antiplatelet strategies.
Authors: Ramzi A Ajjan; Noppadol Kietsiriroje; Lina Badimon; Gemma Vilahur; Diana A Gorog; Dominick J Angiolillo; David A Russell; Bianca Rocca; Robert F Storey Journal: Eur Heart J Date: 2021-06-14 Impact factor: 29.983
Authors: Eline H Ploumen; Tineke H Pinxterhuis; Paolo Zocca; Ariel Roguin; Rutger L Anthonio; Carl E Schotborgh; Edouard Benit; Adel Aminian; Peter W Danse; Carine J M Doggen; Clemens von Birgelen; Marlies M Kok Journal: Cardiovasc Diabetol Date: 2021-10-30 Impact factor: 9.951