JACC: Cardiovascular Interventions

Volume 5, Issue 6, June 2012 DOI: 10.1016/j.jcin.2012.03.016
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A Global Risk Approach to Identify Patients With Left Main or 3-Vessel Disease Who Could Safely and Efficaciously Be Treated With Percutaneous Coronary Intervention
The SYNTAX Trial at 3 Years

Patrick W. Serruys, Vasim Farooq, Pascal Vranckx, Chrysafios Girasis, Salvatore Brugaletta, Hector M. Garcia-Garcia, David R. Holmes Jr, Arie-Pieter Kappetein, Michael J. Mack, Ted Feldman, Marie-Claude Morice, Elisabeth Ståhle, Stefan James, Antonio Colombo, Peggy Pereda, Jian Huang, Marie-Angèle Morel, Gerrit-Anne Van Es, Keith D. Dawkins, Friedrich W. Mohr and Ewout W. Steyerberg

Author + information

vol. 5 no. 6 606-617
DOI: 
https://doi.org/10.1016/j.jcin.2012.03.016
Published By: 
JACC: Cardiovascular Interventions
Print ISSN: 
1936-8798
Online ISSN: 
1876-7605
History: 
  • Received February 7, 2012
  • Revision received March 16, 2012
  • Accepted March 22, 2012
  • Published online June 1, 2012.
Copyright & Usage: 
American College of Cardiology Foundation

Author Information

  1. Patrick W. Serruys, MD, PhD⁎,⁎ (p.w.j.c.serruys{at}erasmusmc.nl),
  2. Vasim Farooq, MBchB⁎,
  3. Pascal Vranckx, MD⁎,
  4. Chrysafios Girasis, MD⁎,
  5. Salvatore Brugaletta, MD⁎,
  6. Hector M. Garcia-Garcia, MD⁎,
  7. David R. Holmes Jr, MD†,
  8. Arie-Pieter Kappetein, MD, PhD‡,
  9. Michael J. Mack, MD§,
  10. Ted Feldman, MD∥,
  11. Marie-Claude Morice, MD,
  12. Elisabeth Ståhle, MD#,
  13. Stefan James, MD#,
  14. Antonio Colombo, MD⁎⁎,
  15. Peggy Pereda, MS††,
  16. Jian Huang, MD, MS††,
  17. Marie-Angèle Morel, BSc‡‡,
  18. Gerrit-Anne Van Es, PhD‡‡,
  19. Keith D. Dawkins, MD††,
  20. Friedrich W. Mohr, MD§§ and
  21. Ewout W. Steyerberg, PhD∥∥
  1. ⁎
  2. †
  3. ‡
  4. §
  5. ∥
  7. #
  8. ⁎⁎
  9. ††
  10. ‡‡
  11. §§
  12. ∥∥
  1. ↵⁎Reprint requests and correspondence:
    Dr. Patrick W. Serruys, Department of Interventional Cardiology, Erasmus Medical Center, ‘s-Gravendijkwal 230, 3015 CE, Rotterdam, the Netherlands

Abstract

Objectives The aim of this study was to assess the additional value of the Global Risk—a combination of the SYNTAX Score (SXscore) and additive EuroSCORE—in the identification of a low-risk population, who could safely and efficaciously be treated with coronary artery bypass graft surgery (CABG) or percutaneous coronary intervention (PCI).

Background PCI is increasingly acceptable in appropriately selected patients with left main stem or 3-vessel coronary artery disease.

Methods Within the SYNTAX Trial (Synergy between PCI with TAXUS and Cardiac Surgery Trial), all-cause death and major adverse cardiac and cerebrovascular events (MACCE) were analyzed at 36 months in low (GRCLOW) to high Global Risk groups, with Kaplan-Meier, log-rank, and Cox regression analyses.

Results Within the randomized left main stem population (n = 701), comparisons between GRCLOW groups demonstrated a significantly lower mortality with PCI compared with CABG (CABG: 7.5%, PCI: 1.2%, hazard ratio [HR]: 0.16, 95% confidence interval [CI]: 0.03 to 0.70, p = 0.0054) and a trend toward reduced MACCE (CABG: 23.1%, PCI: 15.8%, HR: 0.64, 95% CI: 0.39 to 1.07, p = 0.088). Similar analyses within the randomized 3-vessel disease population (n = 1,088) demonstrated no statistically significant differences in mortality (CABG: 5.2%, PCI: 5.8%, HR: 1.14, 95% CI: 0.57 to 2.30, p = 0.71) or MACCE (CABG: 19.0%, PCI: 24.7%, HR: 1.35, 95% CI: 0.95 to 1.92, p = 0.10). Risk-model performance and reclassification analyses demonstrated that the EuroSCORE—with the added incremental benefit of the SXscore to form the Global Risk—enhanced the risk stratification of all PCI patients.

Conclusions In comparison with the SXscore, the Global Risk, with a simple treatment algorithm, substantially enhances the identification of low-risk patients who could safely and efficaciously be treated with CABG or PCI.

Key Words

Footnotes

  • The SYNTAX study was funded by Boston Scientific. Dr. Mack has served on the Speaker's Bureau of Boston Scientific, Cordis, and Medtronic. Dr. Feldman serves on the Speaker's Bureau of Boston Scientific; receives grant support from Abbott, Atritech, Boston Scientific, Edwards, and Evalve; and consults for Abbott, Coherex, Intervalve, Square One, and W.L. Gore. Dr. Morice reports that her institution received a research grant from Boston Scientific. Dr. Dawkins, Ms. Pereda, and Dr. Huang are all full-time employees of Boston Scientific. Dr. Dawkins holds stock in Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Stephen G. Ellis, MD, served as Guest Editor for this paper. Drs. Serruys and Farooq contributed equally to this paper.

  • Received February 7, 2012.
  • Revision received March 16, 2012.
  • Accepted March 22, 2012.
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  • Online Appendix

    A Global Risk Approach to Identify Patients With 3-Vessel and/or Left Main Stem Disease Who Could Safely and Efficaciously Be Treated With Percutaneous Coronary Intervention

    [S1936879812003664_mmc1.docx]

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