Differences among clinical trials and registries on surgical and percutaneous coronary interventions.

Overview

abstract

BACKGROUND: No systematic evaluation of the differences in baseline characteristics and early outcome between patients enrolled in randomized controlled trials (RCTs) and clinical practice has been performed for coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI). METHODS: Systematic searches were conducted to identify RCTs comparing CABG vs PCI and CABG or PCI registries. Sixteen predefined baseline characteristics and 30-day mortality were extracted from the included studies. Pooled proportion and mean with 95% confidence interval were calculated for binary and continuous outcomes respectively using random-effect model. RESULTS: Fourteen RCTs and 10 registries including over 2 million patients were included. Registry patients who underwent CABG had a higher prevalence of hypertension, smoking, reduced left ventricular ejection fraction (LVEF), and prior myocardial infarction, but a lower prevalence of single vessel disease when compared to CABG patients included in RCTs. Regarding PCI, hypertension, hyperlipidemia, left main coronary disease, triple-vessel coronary disease, and NYHA class < IV were significantly more prevalent among RCTs patients, while age, reduced LVEF, and smoking, were more represented among registry PCI patients. Thirty-day mortality was higher in registries for both PCI and CABG patients. CONCLUSION: There were significant differences in baseline characteristics and thirty-day mortality between patients enrolled in RCTs comparing CABG vs PCI and CABG and PCI registries, however results were mixed, and the discrepancy was less than seen in other fields.