Polymer-free drug-eluting stent in unselected patient population: a single center experience

Objective: To evaluate the clinical performance of the Cre8™ polymer-free drug-eluting-stent in unselected real-life population.

Background: Inflammation plays a key role in the multi-factorial process eventually leading to target vessel failure (TVF) after drug-eluting-stent (DES) implantation. The local chronic inflammatory reaction in the vessel wall at the site of stent implantation is, at least in part, attributed to interaction between the polymer coating of DES and vessel wall components. The belief that elimination of the polymer will reduce the occurrence of short and long-term TVF has led to the field of polymer-free DES development.

Methods and results: In this prospective, open-labeled, single-center, uncontrolled trial we enrolled consecutive patients undergoing PCI to receive the Cre8™ stent. The only exclusion criteria were in-stent restenosis and target vessel diameter <2.5mm. Primary end points were cardiac death and target vessel failure (TVF) at 1-year. Overall, 215 patients were enrolled, in which 318 Cre8 stents were implanted. Study population was characterized by a high prevalence of comorbidities including 38% of diabetics. More than 50% presented with acute coronary syndromes. During 1-year of follow-up there were 1 case of sudden death and 1 case of non-cardiac death, as well as 2 cases of TVF.

Conclusion: In this small single-center trial of unselected real-life population, the polymer-free Cre8™ DES appears to be effective, as it was associated with very low rates of target-vessel-failure up to 1-year follow-up.