title: Prognostic value of site SYNTAX score and rationale for combining anatomic and clinical factors in decision making: insights from the SYNTAX trial.
abstract: BACKGROUND
  The results of SYNTAX trial have been reported based on "corelab" calculated SS (cSS). It has been shown that reproducibility of SS is better among the core laboratory technicians than interventional cardiologists. Thus, the prognostic value and clinical implication of the "site" SYNTAX SS (sSS) remain unknown.
  
  
  OBJECTIVE
  The study sought to evaluate the prognostic value and clinical implication of the sSS after percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery in the randomized SYNTAX trial.
  
  
  METHODS
  The sSS was calculated by the site investigators before randomization in the SYNTAX trial. New tertiles based on the sSS were defined with low (0 to 19), intermediate (20 to 27), and high (≥28) scores. The clinical endpoints were compared between PCI and CABG by Kaplan-Meier estimates, log-rank comparison, and Cox regression analyses using the new tertiles. The sSS-based SS II was calculated and its predictive performance was evaluated.
  
  
  RESULTS
  The mean difference in cSS and sSS is 3.8 ± 11.2, with a mean absolute difference of 8.9 ± 7.8. In the overall cohort, using sSS there was a higher incidence of major adverse cardiac and cerebrovascular events (MACCE) at 5-year follow-up in the PCI group for low (31.9% vs. 24.5%; p = 0.054), intermediate (39.5% vs. 29.5%; p = 0.019), and high (43.0% vs. 31.4%; p = 0.003) tertiles, compared with the CABG group. Similarly, in the 3-vessel disease subgroup, 5-year MACCE rates were higher in PCI group in all tertiles. Conversely, in the left main subgroup, MACCE rates were similar for PCI and CABG groups in all tertiles. The sSS-based SS II (c-index: 0.736) had predictive performance similar to the cSS-based SS II (c-index: 0.744), with net reclassification index of -0.0062 (p = 0.79).
  
  
  CONCLUSIONS
  Appropriate training and unbiased assessment are needed when using SS in clinical decision making. sSS and tertiles based on sSS showed poor discrimination among low, intermediate, and high-risk groups. However, combining clinical factors with sSS retained the predictive performance of SS II. (SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries; NCT00114972).
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands; Nanjing First Hospital, Nanjing Medical University, Nanjing, China.
authors.forename: Yao-Jun
authors.initials: YJ
authors.lastname: Zhang
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
authors.forename: Javaid
authors.initials: J
authors.lastname: Iqbal
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
authors.forename: Carlos M
authors.initials: CM
authors.lastname: Campos
authors.affiliation: Department of Public Health, Erasmus Medical Center, Rotterdam, the Netherlands.
authors.forename: David V
authors.initials: DV
authors.lastname: Klaveren
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
authors.forename: Christos V
authors.initials: CV
authors.lastname: Bourantas
authors.affiliation: Boston Scientific Corporation, Natick, Massachusetts.
authors.forename: Keith D
authors.initials: KD
authors.lastname: Dawkins
authors.affiliation: Oxford University Hospitals, Oxford, United Kingdom.
authors.forename: Adrian P
authors.initials: AP
authors.lastname: Banning
authors.affiliation: Clinico San Carlos University Hospital, Madrid, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Escaned
authors.affiliation: Cardialysis BV, Rotterdam, the Netherlands.
authors.forename: Ton
authors.initials: T
authors.lastname: de Vries
authors.affiliation: Cardialysis BV, Rotterdam, the Netherlands.
authors.forename: Marie-Angèle
authors.initials: MA
authors.lastname: Morel
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
authors.forename: Vasim
authors.initials: V
authors.lastname: Farooq
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Onuma
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
authors.forename: Hector M
authors.initials: HM
authors.lastname: Garcia-Garcia
authors.affiliation: Columbia University Medical Center/New York-Presbyterian Hospital, Cardiovascular Research Foundation, New York, New York.
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
authors.affiliation: Department of Public Health, Erasmus Medical Center, Rotterdam, the Netherlands.
authors.forename: Ewout W
authors.initials: EW
authors.lastname: Steyerberg
authors.affiliation: Herzzentrum Universität Leipzig, Leipzig, Germany.
authors.forename: Friedrich W
authors.initials: FW
authors.lastname: Mohr
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands; Imperial College London, London, United Kingdom. Electronic address: patrick.w.j.c.serruys@gmail.com.
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
mesh_terms: D001026:Coronary Artery Bypass / Q000379:methods*; D003324:Coronary Artery Disease / Q000601:surgery*; D003657:Decision Making; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D011183:Postoperative Complications / Q000453:epidemiology*; D011379:Prognosis; D016016:Proportional Hazards Models; D011446:Prospective Studies; D015203:Reproducibility of Results; D015996:Survival Rate / Q000639:trends; D014481:United States / Q000453:epidemiology
keywords: MACCE; SYNTAX score; SYNTAX score II; corelab SS; site SS