Impact of long-term ticagrelor monotherapy following 1-month dual antiplatelet therapy in patients who underwent complex percutaneous coronary intervention: insights from the Global Leaders trial-Reference-Cited by-同舟云学术

Impact of long-term ticagrelor monotherapy following 1-month dual antiplatelet therapy in patients who underwent complex percutaneous coronary intervention: insights from the Global Leaders trial

Published:2019-08-09 Issue:31 Volume:40 Page:2595-2604
ISSN:0195-668X
Container-title:European Heart Journal
language:en
Short-container-title:

Author:

Serruys Patrick W¹^ORCID,Takahashi Kuniaki²^ORCID,Chichareon Ply²³^ORCID,Kogame Norihiro²^ORCID,Tomaniak Mariusz⁴⁵^ORCID,Modolo Rodrigo²⁶^ORCID,Chang Chun Chin⁴,Komiyama Hidenori²,Soliman Osama⁴⁷^ORCID,Wykrzykowska Joanna J²,de Winter Robbert J²^ORCID,Ferrario Maurizio⁸,Dominici Marcello⁹,Buszman Paweł¹⁰¹¹,Bolognese Leonardo¹²,Tumscitz Carlo¹³,Benit Edouard¹⁴,Stoll Hans-Peter¹⁵^ORCID,Hamm Christian¹⁶,Steg Philippe Gabriel¹⁷,Onuma Yoshinobu⁴⁷,Jüni Peter¹⁸,Windecker Stephan¹⁹^ORCID,Vranckx Pascal¹⁴,Colombo Antonio²⁰,Valgimigli Marco¹⁹

Affiliation:

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

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 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.

Funder

AstraZeneca

Biosensors

The Medicines Company

Sao Paulo Research Foundation

Publisher

Oxford University Press (OUP)

Subject

Cardiology and Cardiovascular Medicine

Link

http://academic.oup.com/eurheartj/advance-article-pdf/doi/10.1093/eurheartj/ehz453/29113699/ehz453.pdf

Reference21 articles.