TY - JOUR
T1 - Prognostic value of site SYNTAX score and rationale for combining anatomic and clinical factors in decision making
T2 - Insights from the SYNTAX trial
AU - Zhang, Yao Jun
AU - Iqbal, Javaid
AU - Campos, Carlos M.
AU - Klaveren, David V.
AU - Bourantas, Christos V.
AU - Dawkins, Keith D.
AU - Banning, Adrian P.
AU - Escaned, Javier
AU - De Vries, Ton
AU - Morel, Marie Angèle
AU - Farooq, Vasim
AU - Onuma, Yoshinobu
AU - Garcia-Garcia, Hector M.
AU - Stone, Gregg W.
AU - Steyerberg, Ewout W.
AU - Mohr, Friedrich W.
AU - Serruys, Patrick W.
N1 - Funding Information:
The SYNTAX trial was funded by Boston Scientific . Dr. Banning has received speaker and advisory honoraria from Medtronic, Boston Scientific, and Abbott Vascular. Dr. Dawkins is a full-time employee and holds stock in Boston Scientific. Dr. Stone has served as consultant for Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
PY - 2014/8/5
Y1 - 2014/8/5
N2 - 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. Objectives 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)
AB - 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. Objectives 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)
KW - MACCE
KW - SYNTAX score
KW - SYNTAX score II
KW - corelab SS
KW - site SS
UR - http://www.scopus.com/inward/record.url?scp=84905168442&partnerID=8YFLogxK
U2 - 10.1016/j.jacc.2014.05.022
DO - 10.1016/j.jacc.2014.05.022
M3 - Article
C2 - 25082573
AN - SCOPUS:84905168442
SN - 0735-1097
VL - 64
SP - 423
EP - 432
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 5
ER -