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, Ewout W Steyerberg, 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, Ewout W Steyerberg
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 (GRC(LOW)) 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 GRC(LOW) 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.
Trial registration: ClinicalTrials.gov NCT00114972.
Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed