Kuniaki Takahashi1, Patrick W Serruys2, Ply Chichareon3, Chun Chin Chang4, Mariusz Tomaniak5, Rodrigo Modolo6, Norihiro Kogame1, Michael Magro7, Saqib Chowdhary8, Ingo Eitel9, Robert Zweiker10, Paul Ong11, Michael Mundt Ottesen12, Jan G P Tijssen13, Joanna J Wykrzykowska1, Robbert J de Winter1, Scot Garg14, Hans-Peter Stoll15, Christian Hamm16, Philippe Gabriel Steg17, Yoshinobu Onuma18, Marco Valgimigli19, Pascal Vranckx20, Didier Carrie21, Stephan Windecker19. 1. Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands. 2. International Centre for Circulatory Health, Imperial College London, London, United Kingdom. Electronic address: patrick.w.j.c.serruys@gmail.com. 3. Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Division of Cardiology, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand. 4. Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands. 5. Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands; First Department of Cardiology, Medical University of Warsaw, Warsaw, Poland. 6. Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Department of Internal Medicine, Cardiology Division, University of Campinas (UNICAMP), Campinas, Brazil. 7. TweeSteden Ziekenhuis, Tilburg, the Netherlands. 8. Manchester University Foundation Trust, Manchester, United Kingdom. 9. University Heart Center Lübeck, Medical Clinic II (Cardiology/Angiology/Intensive Care Medicine) and German Center for Cardiovascular Research (DZHK), partner site Hamburg/Kiel/Lübeck, Lübeck, Germany. 10. Medical University Hospital Graz, Graz, Austria. 11. Tan Tock Seng Hospital, Singapore. 12. Zealand University Hospital, Roskilde, Denmark. 13. Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Cardialysis B.V., Rotterdam, the Netherlands. 14. Royal Blackburn Hospital, Blackburn, United Kingdom. 15. Biosensors Clinical Research, Morges, Switzerland. 16. University of Giessen and Kerckhoff Heart and Thorax Center, University of Giessen, Bad Nauheim, Germany. 17. FACT (French Alliance for Cardiovascular Trials), Université Paris-Diderot, Paris, France. 18. Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands; Cardialysis B.V., Rotterdam, the Netherlands. 19. Department of Cardiology, University of Bern, Inselspital, Bern, Switzerland. 20. Jessa Ziekenhuis, Faculty of Medicine and Life Sciences at the Hasselt University, Hasselt, Belgium. 21. Rangueil Hospital, Toulouse, France.
Abstract
BACKGROUND: Data on optimal antiplatelet treatment regimens in patients who undergo multivessel percutaneous coronary intervention (PCI) are sparse. OBJECTIVES: This post hoc study investigated the impact of an experimental strategy (1-month dual antiplatelet therapy [DAPT] followed by 23-month ticagrelor monotherapy) versus a reference regimen (12-month DAPT followed by 12-month aspirin monotherapy) according to multivessel PCI. METHODS: The GLOBAL LEADERS trial is a prospective, multicenter, open-label, randomized controlled trial, allocating all-comer patients in a 1:1 ratio to either the experimental strategy or the reference regimen. The primary endpoint was the composite of all-cause death or new Q-wave myocardial infarction at 2 years. The secondary safety endpoint was Bleeding Academic Research Consortium type 3 or 5 bleeding. RESULTS: Among the overall study population (n=15,845), 3,576 patients (22.4%) having multivessel PCI experienced a significantly higher risk of ischemic and bleeding events at 2 years, compared to those having single-vessel PCI. There was an interaction between the experimental strategy and multivessel PCI on the primary endpoint (hazard ratio: 0.62; 95% confidence interval: 0.44 to 0.88; pinteraction = 0.031). This difference was largely driven by a lower risk of all-cause mortality. In contrast, the risk of Bleeding Academic Research Consortium type 3 or 5 bleeding was statistically similar between the 2 regimens (hazard ratio: 0.92; 95% confidence interval: 0.61 to 1.39; pinteraction = 0.754). CONCLUSIONS: Long-term ticagrelor monotherapy following 1-month DAPT can favorably balance ischemic and bleeding risks in patients with multivessel PCI. These findings should be interpreted as hypothesis-generating and need to be replicated in future dedicated randomized trials. (GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation; NCT01813435).
RCT Entities:
BACKGROUND: Data on optimal antiplatelet treatment regimens in patients who undergo multivessel percutaneous coronary intervention (PCI) are sparse. OBJECTIVES: This post hoc study investigated the impact of an experimental strategy (1-month dual antiplatelet therapy [DAPT] followed by 23-month ticagrelor monotherapy) versus a reference regimen (12-month DAPT followed by 12-month aspirin monotherapy) according to multivessel PCI. METHODS: The GLOBAL LEADERS trial is a prospective, multicenter, open-label, randomized controlled trial, allocating all-comer patients in a 1:1 ratio to either the experimental strategy or the reference regimen. The primary endpoint was the composite of all-cause death or new Q-wave myocardial infarction at 2 years. The secondary safety endpoint was Bleeding Academic Research Consortium type 3 or 5 bleeding. RESULTS: Among the overall study population (n=15,845), 3,576 patients (22.4%) having multivessel PCI experienced a significantly higher risk of ischemic and bleeding events at 2 years, compared to those having single-vessel PCI. There was an interaction between the experimental strategy and multivessel PCI on the primary endpoint (hazard ratio: 0.62; 95% confidence interval: 0.44 to 0.88; pinteraction = 0.031). This difference was largely driven by a lower risk of all-cause mortality. In contrast, the risk of Bleeding Academic Research Consortium type 3 or 5 bleeding was statistically similar between the 2 regimens (hazard ratio: 0.92; 95% confidence interval: 0.61 to 1.39; pinteraction = 0.754). CONCLUSIONS: Long-term ticagrelor monotherapy following 1-month DAPT can favorably balance ischemic and bleeding risks in patients with multivessel PCI. These findings should be interpreted as hypothesis-generating and need to be replicated in future dedicated randomized trials. (GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation; NCT01813435).
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