Patrick W Serruys1, Kuniaki Takahashi2, Ply Chichareon2,3, Norihiro Kogame2, Mariusz Tomaniak4,5, Rodrigo Modolo2,6, Chun Chin Chang4, Hidenori Komiyama2, Osama Soliman4,7, Joanna J Wykrzykowska2, Robbert J de Winter2, Maurizio Ferrario8, Marcello Dominici9, Paweł Buszman10,11, Leonardo Bolognese12, Carlo Tumscitz13, Edouard Benit14, Hans-Peter Stoll15, Christian Hamm16, Philippe Gabriel Steg17, Yoshinobu Onuma4,7, Peter Jüni18, Stephan Windecker19, Pascal Vranckx14, Antonio Colombo20, Marco Valgimigli19. 1. National Heart and Lung Institute, Imperial College London, Guy Scadding Building, Dovehouse St, Chelsea, London, UK. 2. Department of Cardiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, AZ, Amsterdam, The Netherlands. 3. Division of Cardiology, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, 15 Karnjanavanich Road, Kho Hong, Hat Yai, Songkhla, Thailand. 4. Department of Cardiology, Erasmus Medical University Center, Thorax Centre, Molewaterplein 40, GD Rotterdam, The Netherlands. 5. First Department of Cardiology, Medical University of Warsaw, Żwirki i Wigury Str. 61, Warsaw, Poland. 6. Department of Internal Medicine, Cardiology Division, University of Campinas (UNICAMP), Cidade Universitária Zeferino Vaz - Barão Geraldo, Campinas - SP, Brazil. 7. Cardialysis B.V., Westblaak 98, KM Rotterdam, The Netherlands. 8. Department of Cardiology, Fondazione IRCCS Policlinico San Matteo, Viale Camillo Golgi, 19, Pavia PV, Italy. 9. Department of Cardiology, Azienda Ospedaliera S. Maria, Viale Tristano di Joannuccio, Terni TR, Italy. 10. Center for Cardiovascular Research and Development, American Heart of Poland, Sanatoryjna 1, Ustroń, Poland. 11. Department of Epidemiology and Statistics, Medical University of Silesia, Poniatowskiego 15, Katowice. 12. Cardiovascular Department, San Donato Hospital, Via Pietro Nenni, 20/22, 52100 Arezzo, Italy. 13. Department of Cardiology, Azienda Ospedaliero Universitaria di Ferrara, Via Aldo Moro, 8, Cona FE, Italy. 14. Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Stadsomvaart 11, 3500 Hasselt, Belgium and Faculty of Medicine and Life Sciences, University of Hasselt, Martelarenlaan 42, Hasselt, Belgium. 15. Biosensors Europe, Rue de Lausanne 29, Morges, Switzerland. 16. Kerckhoff Clinic and Thoraxcenter of the University of Giessen, Benekestraße 2-8, Bad Nauheim, Germany. 17. Université Paris-Diderot, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, INSERM U-1148, French Alliance for Cardiovascular Trials, Paris, France. 18. Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, Department of Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, 209 Victoria St, Toronto, ON, Canada. 19. Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 4, Bern, Switzerland. 20. Department of Cardiology, Maria Cecilia Hospital-GVM, Via Madonna di Genova, 1, Cotignola RA, Italy.
Abstract
AIMS: To evaluate the impact of an experimental strategy [23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT)] vs. a reference regimen (12-month aspirin monotherapy following 12-month DAPT) after complex percutaneous coronary intervention (PCI). METHODS AND RESULTS: In the present post hoc analysis of the Global Leaders trial, the primary endpoint [composite of all-cause death or new Q-wave myocardial infarction (MI)] at 2 years was assessed in patients with complex PCI, which includes at least one of the following characteristics: multivessel PCI, ≥3 stents implanted, ≥3 lesions treated, bifurcation PCI with ≥2 stents, or total stent length >60 mm. In addition, patient-oriented composite endpoint (POCE) (composite of all-cause death, any stroke, any MI, or any revascularization) and net adverse clinical events (NACE) [composite of POCE or Bleeding Academic Research Consortium (BARC) Type 3 or 5 bleeding] were explored. Among 15 450 patients included in this analysis, 4570 who underwentcomplex PCI had a higher risk of ischaemic and bleeding events. In patients with complex PCI, the experimental strategy significantly reduced risks of the primary endpoint [hazard ratio (HR): 0.64, 95% confidence interval (CI): 0.48-0.85] and POCE (HR: 0.80, 95% CI: 0.69-0.93), but not in those with non-complex PCI (Pinteraction = 0.015 and 0.017, respectively). The risk of BARC Type 3 or 5 bleeding was comparable (HR: 0.97, 95% CI: 0.67-1.40), resulting in a significant risk reduction in NACE (HR: 0.80, 95% CI: 0.69-0.92; Pinteraction = 0.011). CONCLUSION:Ticagrelor monotherapy following 1-month DAPT could provide a net clinical benefit for patients with complex PCI. However, in view of the overall neutral results of the trial, these findings of a post hoc analysis should be considered as hypothesis generating. Published on behalf of the European Society of Cardiology. All rights reserved.
RCT Entities:
AIMS: To evaluate the impact of an experimental strategy [23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT)] vs. a reference regimen (12-month aspirin monotherapy following 12-month DAPT) after complex percutaneous coronary intervention (PCI). METHODS AND RESULTS: In the present post hoc analysis of the Global Leaders trial, the primary endpoint [composite of all-cause death or new Q-wave myocardial infarction (MI)] at 2 years was assessed in patients with complex PCI, which includes at least one of the following characteristics: multivessel PCI, ≥3 stents implanted, ≥3 lesions treated, bifurcation PCI with ≥2 stents, or total stent length >60 mm. In addition, patient-oriented composite endpoint (POCE) (composite of all-cause death, any stroke, any MI, or any revascularization) and net adverse clinical events (NACE) [composite of POCE or Bleeding Academic Research Consortium (BARC) Type 3 or 5 bleeding] were explored. Among 15 450 patients included in this analysis, 4570 who underwent complex PCI had a higher risk of ischaemic and bleeding events. In patients with complex PCI, the experimental strategy significantly reduced risks of the primary endpoint [hazard ratio (HR): 0.64, 95% confidence interval (CI): 0.48-0.85] and POCE (HR: 0.80, 95% CI: 0.69-0.93), but not in those with non-complex PCI (Pinteraction = 0.015 and 0.017, respectively). The risk of BARC Type 3 or 5 bleeding was comparable (HR: 0.97, 95% CI: 0.67-1.40), resulting in a significant risk reduction in NACE (HR: 0.80, 95% CI: 0.69-0.92; Pinteraction = 0.011). CONCLUSION:Ticagrelor monotherapy following 1-month DAPT could provide a net clinical benefit for patients with complex PCI. However, in view of the overall neutral results of the trial, these findings of a post hoc analysis should be considered as hypothesis generating. Published on behalf of the European Society of Cardiology. All rights reserved.
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