Validating the EXCEL hypothesis: a propensity score matched 3-year comparison of percutaneous coronary intervention versus coronary artery bypass graft in left main patients with SYNTAX score ≤32.

OBJECTIVES: The aim of this study is to verify the study hypothesis of the EXCEL trial by comparing percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) in an EXCEL-like population of patients. BACKGROUND: The upcoming EXCEL trial will test the hypothesis that left main patients with SYNTAX score ≤ 32 experience similar rates of 3-year death, myocardial infarction (MI), or cerebrovascular accidents (CVA) following revascularization by PCI or CABG. METHODS: We compared the 3-year rates of death/MI/CVA and death/MI/CVA/target vessel revascularization (MACCE) in 556 patients with left main disease and SYNTAX score ≤ 32 undergoing PCI (n = 285) or CABG (n = 271). To account for confounders, outcome parameters underwent extensive statistical adjustment. RESULTS: The unadjusted incidence of death/MI/CVA was similar between PCI and CABG (12.7% vs. 8.4%, P = 0.892), while MACCE were higher in the PCI group compared to the CABG group (27.0% vs. 11.8%, P < 0.001). After propensity score matching, PCI was not associated with a significant increase in the rate of death/MI/CVA (11.8% vs. 10.7%, P = 0.948), while MACCE were more frequently noted among patients treated with PCI (28.8% vs. 14.1%, P = 0.002). Adjustment by means of SYNTAX score and EUROSCORE, covariates with and without propensity score, and propensity score alone did not change significantly these findings. CONCLUSIONS: In an EXCEL-like cohort of patients with left main disease, there seems to be a clinical equipoise between PCI and CABG in terms of death/MI/CVA. However, even in patients with SYNTAX score ≤ 32, CABG is superior to PCI when target vessel revascularization is included in the combined endpoint.

EuroSCORE refines the predictive ability of SYNTAX score in patients undergoing left main percutaneous coronary intervention.

BACKGROUND: Whether SYNTAX score should be used as a stand-alone tool or whether its performance may be improved by the parallel use of clinical scores focusing on comorbidities, such as EuroSCORE, is a matter of debate. METHODS: A combined risk model including both clinical and angiographic information was developed, and its performance tested on a contemporary population of 255 patients with left main disease undergoing percutaneous coronary intervention (PCI). A global risk classification (GRC) system was created by combination of SYNTAX score and EuroSCORE strata, and new classes of risk were defined. RESULTS: When EuroSCORE was fitted into the SYNTAX score model, c-statistic increased from 0.681 to 0.732 for the prediction of cardiac mortality. The likelihood ratio test for the significance of adding the EuroSCORE term to the model was chi(2) = 4.109 (P = .043) with a net reclassification improvement of 26% (P = .002). GRC showed the best prediction and discriminative ability in terms of two-year cardiac mortality (HR 3.40, 95% CI 1.79-6.43, P < .001; c-statistic 0.756) as compared with SYNTAX score (HR 2.87, 95% CI 1.35-6.10, P = .006; c-statistic 0.747) and EuroSCORE (HR 3.04, 95% CI 1.41-6.57, P = .005; c-statistic 0.708) alone. CONCLUSIONS: We found a significant improvement in the prediction of cardiac mortality with the inclusion of EuroSCORE in a SYNTAX score-based model. The degree of reclassification between treatment threshold categories indicates that clinical and angiographic information are both important for assessing individual risk of patients undergoing left main PCI.

Global risk classification and clinical SYNTAX (synergy between percutaneous coronary intervention with TAXUS and cardiac surgery) score in patients undergoing percutaneous or surgical left main revascularization.

OBJECTIVES: The aim of this study was to investigate the ability to predict cardiac mortality of the Global Risk Classification (GRC) and the Clinical SYNTAX (Synergy between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery) score (CSS) in left main (LM) patients undergoing percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG). BACKGROUND: There is a renewed interest in combining clinical and angiographic information to define the risk of patients undergoing LM revascularization. METHODS: The GRC and CSS were assessed in patients undergoing LM PCI (n = 400) or CABG (n = 549). Stand-alone clinical (ACEF [age, creatinine, ejection fraction]), EuroSCORE (European System for Cardiac Operative Risk Evaluation) and angiographic (SYNTAX score) risk scores were also investigated. RESULTS: The GRC (Hosmer-Lemeshow statistic 0.357, p = 0.550; area under the curve 0.743) and the ACEF (Hosmer-Lemeshow 0.426, p = 0.514; area under the curve 0.741) showed the most balanced predictive characteristics in the PCI and CABG cohorts, respectively. In PCI patients, the CSS used fewer data to achieve similar discrimination but poorer calibration than the GRC. Propensity-adjusted outcomes were comparable between PCI and CABG patients with low, intermediate, or high EuroSCORE, ACEF, GRC, and CSS and those with low or intermediate SYNTAX score. Conversely, in the group with the highest SYNTAX score, the risk of cardiac mortality was significantly higher in PCI patients (hazard ratio: 2.323, 95% confidence interval: 1.091 to 4.945, p = 0.029). CONCLUSIONS: In LM patients undergoing PCI, combined scores improve the discrimination accuracy of clinical or angiographic stand-alone tools. In LM patients undergoing CABG, the ACEF score has the best prognostic accuracy compared with other stand-alone or combined scores. The good predictive ability for PCI along with the poor predictive ability for CABG make the SYNTAX score the preferable decision-making tool in LM disease.

Routine versus selective coronary artery bypass for left main coronary artery revascularization: the Appraise a Customized Strategy for Left Main Revascularization (CUSTOMIZE) study.

BACKGROUND: Current guidelines recommend coronary artery bypass grafting (CABG) as the first choice of revascularization in patients with unprotected left main coronary artery (ULMCA) disease. We tested the hypothesis that a non guideline-driven approach to ULMCA revascularization which uses percutaneous coronary intervention (PCI) by default and CABG in selected patients may be as safe as the traditional guideline-driven approach. METHODS: Between March 2002 and December 2008, PCI has been used as a default strategy for ULMCA revascularization in Center 1 (non guideline-driven [NGD] group), whereas CABG has been used as a default strategy in Center 2 (guideline-driven [GD] group). RESULTS: A total of 838 patients with ULMCA disease were included. Of these 67.1% and 32.9% were treated in the NGD and GD groups, respectively. A significant higher risk of major adverse cardiac events (MACE) (hazard ratio [HR] 1.60, 95% confidence interval [CI] 1.10-2.33, p=0.014) and target vessel revascularization (HR 2.44, 95% CI 1.26-4.72, p=0.008) occurred at 24 months in the NGD group as compared with GD Group. Adjustment by means of propensity score did not result in substantial changes with regard to the subcomponent safety and efficacy endpoints. Conversely, the composite of MACE was no longer significant according to all types of statistical adjustment. CONCLUSIONS: In a large registry of patients with ULMCA disease undergoing revascularization in current clinical practice, an approach based on PCI and the selective use of CABG gives results which are not inferior to those of a traditional approach guided by the current guidelines.

Usefulness of the SYNTAX score for predicting clinical outcome after percutaneous coronary intervention of unprotected left main coronary artery disease.

BACKGROUND: The SYNTAX score (SXscore) has been proposed recently as a valuable tool to characterize the coronary vasculature prospectively with respect to the number of lesions and their functional impact, location, and complexity. However, the prognostic value of SXscores in patients undergoing percutaneous coronary intervention of the left main artery has not been validated. METHODS AND RESULTS: We applied the SXscore in 255 consecutive patients who underwent percutaneous coronary intervention for left main disease and explored its performance with respect to their clinical outcome. Univariate and multivariate Cox proportional hazard regression analyses were performed to evaluate the relation between the SXscore and the incidence of cardiac mortality, the primary end point of the study, and major adverse cardiac events (MACE). At 1 year, the SXscore significantly predicted the risk of cardiac death (hazard ratio, 1.12/unit increase; 95% CI, 1.06 to 1.18; P<0.001) and MACE (hazard ratio, 1.59/unit increase; 95% CI, 1.02 to 2.48; P=0.043). After adjustment for potential confounders, a higher SXscore remained significantly associated with cardiac mortality (adjusted hazard ratio, 1.15; 95% CI, 1.05 to 1.26; P=0.003) and MACE (adjusted hazard ratio, 1.06; 95% CI, 1.02 to 1.10; P=0.005). C-indexes for SXscores in terms of cardiac death and MACE were 0.83 and 0.64, respectively. Using classification tree analysis, discrimination levels of 34 and 37 were identified as the optimal cutoff to distinguish between patients at low and high risk of cardiac death and MACE, respectively. CONCLUSIONS: The SXscore is a useful tool to predict cardiac mortality and MACE in patients undergoing percutaneous revascularization of the left main coronary artery.

Usefulness of SYNTAX score to select patients with left main coronary artery disease to be treated with coronary artery bypass graft.

OBJECTIVES: The purpose of our study was to investigate the utility of the SYNTAX (Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery) score in aiding patient selection for percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in a large contemporary registry of patients undergoing revascularization of left main coronary artery. BACKGROUND: The SYNTAX score has been developed as a combination of several validated angiographic classifications aiming to grade the coronary lesions with respect to their functional impact, location, and complexity. METHODS: Between March 2002 and December 2008, 819 patients with left main coronary artery disease underwent revascularization in 2 Italian centers. We compared clinical outcomes of PCI versus CABG in patients with SYNTAX score < or =34 and patients with SYNTAX score >34. RESULTS: The rates of 2-year mortality were similar between CABG and PCI in the group of patients with SYNTAX score < or =34 (6.2% vs. 8.1%, p = 0.461). Among patients with SYNTAX score >34, those treated with CABG had lower rates of mortality (8.5% vs. 32.7%, p < 0.001) than those treated with PCI. After statistical adjustment, revascularization by PCI resulted in a similar risk of death compared with CABG in patients with SYNTAX score < or =34 (hazard ratio: 0.81, 95% confidence interval: 0.33 to 1.99, p = 0.64) and in a significantly higher risk in patients with SYNTAX score >34 (hazard ratio: 2.54, 95% confidence interval: 1.09 to 5.92, p = 0.031). CONCLUSIONS: A SYNTAX score threshold of 34 may usefully identify a cohort of patients with left main disease who benefit most from surgical revascularization in terms of mortality.