Ply Chichareon1,2, MD; Yoshinobu Onuma3, MD, PhD; David van Klaveren4, PhD; Rodrigo Modolo1,5, MD; Norihiro Kogame1, MD; Kuniaki Takahashi1, MD; Chun Chin Chang3, MD; Mariusz Tomaniak3,6, MD; Taku Asano1, MD; Yuki Katagiri1, MD; Robert-Jan M. van Geuns7, MD, PhD; Leonardo Bolognese8, MD; Carlo Tumscitz9, MD; Mathias Vrolix10, MD; Ivo Petrov11, MD; Scot Garg12, MD, PhD; Christoph Kurt Naber13, MD; Manel Sabaté14, MD, PhD; Javaid Iqbal15, MD, PhD; Joanna J. Wykrzykowska1, MD, PhD; Jan J. Piek1, MD, PhD; Ernest Spitzer3,16, MD; Peter Jüni17, MD, PhD; Christian Hamm18, MD; Philippe Gabriel Steg19,20, MD; Marco Valgimigli21, MD, PhD; Pascal Vranckx22, MD, PhD; Stephan Windecker21, MD, PhD; Patrick W. Serruys23, MD, PhD
1. Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Meibergdreef 9, Amsterdam, the Netherlands; 2. Division of Cardiology, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand; 3. Erasmus Medical Center, Erasmus University, Rotterdam, the Netherlands; 4. Department of Biomedical Data Sciences, Leiden University Medical Center, The Netherlands; 5. Department of Internal Medicine, Cardiology Division, University of Campinas (UNICAMP), Campinas, Brazil; 6. First Department of Cardiology, Medical University of Warsaw, Warsaw, Poland; 7. Department of Cardiology, Erasmus Medical Center, Rotterdam, the Netherlands; 8. Cardiovascular Department, San Donato Hospital, Arezzo, Italy; 9. Cardiology Unit, Azienda Ospedaliero Universitaria di Ferrara, Cona, Italy; 10. Oost Limburg Hospital, Genk, Belgium; 11. Acibadem City Clinic, Cardiovascular center, Sofia, Bulgaria; 12. East Lancashire Hospitals NHS Trust, Blackburn, Lancashire, UK; 13. Contilia Heart and Vascular Centre, Elisabeth Krankenhaus Essen, Klara-Kopp-Weg 1, 45138 Essen, Germany; 14. Department of Cardiology, Hospital Clínic, Thorax Institute, Barcelona, IDIBAPS, University of Barcelona, Barcelona, Spain; 15. South Yorkshire Cardiothoracic Centre, Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom; 16. Cardialysis Clinical Trials Management and Core Laboratories, Westblaak 98, Rotterdam, the Netherlands; 17. Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael’s Hospital, University of Toronto, Toronto, Canada; 18. Kerckhoff Heart Center, Campus University of Giessen, Bad Nauheim, Germany; 19. FACT, French Alliance for Cardiovascular Trials; Hôpital Bichat, AP-HP; Université Paris-Diderot; and INSERM U-1148, Paris, France; 20. Royal Brompton Hospital, Imperial College, London, United Kingdom; 21. Department of Cardiology, Bern University Hospital, Bern, Switzerland; 22. Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium; 23. NHLI, Imperial College London, London, United Kingdom
Aims: The aim of this study was the external validation of the updated logistic clinical SYNTAX score for two-year all-cause mortality after PCI in the GLOBAL LEADERS trial.
Methods and results: The GLOBAL LEADERS trial was an investigator-initiated, prospective randomised, multicentre, open-label trial comparing two strategies of antiplatelet therapy in 15,991 patients undergoing PCI. As a predefined analysis, we studied the first 4,006 consecutive patients enrolled between July 2013 and April 2014 for whom the anatomic SYNTAX scores were calculated by an independent core lab. The updated logistic clinical SYNTAX score was available in 3,271 patients. Patients were divided into quintiles according to the score. The C-statistic of the updated logistic clinical SYNTAX score for two-year all-cause mortality was 0.71 (95% confidence interval [CI]: 0.64-0.77). The updated logistic clinical SYNTAX score identified patients at very high risk for two-year all-cause mortality after PCI. Although it systematically overestimated two-year all-cause mortality, predicted and observed two-year all-cause mortality in the majority of the patients (four out of five quintiles) were in agreement.
Conclusions: Overall discrimination for two-year all-cause mortality of the updated logistic clinical SYNTAX score is either borderline acceptable or possibly helpful. Calibration in the majority of patients is appropriate. The score is potentially useful in selecting enriched high-risk populations.