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JACC Cardiovasc Interv. 2012 Jun;5(6):606-17. doi: 10.1016/j.jcin.2012.03.016.

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.

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1
Department of Interventional Cardiology, Erasmus University, Medical Centre, Thoraxcenter, Rotterdam, the Netherlands. p.w.j.c.serruys@erasmusmc.nl

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.

PMID:
22721655
DOI:
10.1016/j.jcin.2012.03.016
[Indexed for MEDLINE]
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