Generalizability of EXCEL and NOBLE results to a large registry population with unprotected left main coronary artery disease

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Abstract

Objective

The aim of this study was to determine how trial-based findings of EXCEL and NOBLE might be interpreted and generalizable in ‘real-world’ settings with comparison of data from the large-scaled, all-comer Interventional Research Incorporation Society−Left MAIN Revascularization (IRIS–MAIN) registry.

Patients and methods

We compared baseline clinical and procedural characteristics and also determined how the relative treatment effect of percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) was different in EXCEL and NOBLE, compared with those of the multicenter, IRIS–MAIN registry (n=2481). The primary outcome for between-study comparison was a composite of death, myocardial infarction (MI), or stroke.

Results

There were between-study differences in patient risk profiles (age, BMI, diabetes, and clinical presentation), lesion complexities, and procedural characteristics (stent type, the use of off-pump surgery, and radial artery); the proportion of diabetes and acute coronary syndrome was particularly lower in NOBLE than in other studies. Although there was interstudy heterogeneity for the protocol definition of MI, the risks for serious composite outcome of death, MI, or stroke were similar between PCI and CABG in EXCEL [hazard ratio (HR): 1.00; 95% confidence interval (CI): 0.79–1.26; P=0.98] and in the matched cohort of IRIS–MAIN (HR: 1.08; 95%CI: 0.85–1.38; P=0.53), whereas it was significantly higher after PCI than after CABG in NOBLE (HR: 1.47; 95%CI: 1.06–2.05; P=0.02), which was driven by more common MI and stroke after PCI.

Conclusion

In the comparison of a large-sized, all-comer registry, the EXCEL trial might represent better generalizability with respect to baseline characteristics and observed clinical outcomes compared with the NOBLE trial.

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