Sorin Group initiates patient enrollment in e-Optima registry

The Optima drug-eluting stent (DES) features a specially designed delivery system that allows for optimal DES expansion at implant. The registry will involve 1,000 patients throughout the world (except in the US and Japan). Patients with multiple stenoses in multiple vessels will be allowed in the e-Optima registry, thus making it a real-world registry.

The primary endpoint of e-Optima is the incidence of adjudicated composite rate of cardiac death, myocardial infarction (MI) and clinically-driven target lesion revascularization (TLR) at six months (device-related endpoint). Other major secondary endpoints are duration of dual antiplatelet therapy and thrombosis rate up to two years, measurement of late lumen loss at eight months (in a sub-group population). Data consistency and reliability will be obtained through 100% on-line and 10% (randomly performed) on-site monitoring together with an independent adjudication of any adverse events.

Koolen, the principal investigator of e-Optima, said: “The e-Optima registry will allow us to further confirm the unmatched safety profile provided by the Sorin Group DES technology with a reduced dual antiplatelet therapy as well as assess the Optima DES long term efficacy.

“It has been demonstrated that when increased attention is paid in optimizing DES implantation, its clinical safety and efficacy are enhanced thanks to improved stent strut wall apposition. The Optima innovative delivery system was specifically designed to address this need.”

According to the company, the Optima new-generation DES system offers the unique combination of patented polymer-free drug reservoir and the proven anti-thrombotic and potentially pro-healing integral Carbofilm coating. The innovative delivery system has been designed to improve device deliverability and optimize DES expansion.