EMPIRE (Escorts Multiple ProNova Implantation Registry) Study: Evaluating the ProNova SES in De Novo Coronary Artery Lesions.

ABSTRACT

BACKGROUND: The main limitation of percutaneous coronary intervention (PCI) with bare metal stents was the increased incidence of instant restenosis. The introduction of drug-eluting stents has decreased the rate of restenosis. Various DESs, using different drugs and stent designs, are now being used in interventional cardiology worldwide. The EMPIRE study was conducted to evaluate the safety and efficacy of the slow-release sirolimus-eluting ProNova stent in de novo coronary artery lesions in patients with single- or multi-vessel disease. METHODS AND RESULTS- A total of 300 patients, enrolled in a single-centre registry, were successfully implanted with ProNova, a sirolimus-eluting stent (SES). They were followed up clinically, first at 30 days and then six months after the procedure for parameters like death, target vessel failure, documented myocardial infarction (MI) and restenosis. Assessment of binary restenosis was done angiographically at six months. The primary success rate of stent implantation was 100%, the percentage of acute major adverse cardiac events (MACE) being 0% and 2% at 30 days and six months, respectively. Angiographic restenosis was documented in 12.6% of the patients enrolled in the study. CONCLUSION: The ProNova stent was found to be safe and effective in this trial.