Outcomes of the amphilimus-eluting polymer-free stent for chronic total occlusion treatment: A multicentre experience

Aims: Late stent thrombosis and delayed vessel wall healing remain an important issue in coronary vessels treated with drug-eluting stents (DES), especially when long-vessel segments need to be covered, like in chronic total occlusions (CTO). Avoiding polymer use to avoid chronic inflammatory responses is a potential solution to reduce target vessel failure (TVF). We aimed to validate the clinical safety and efficacy at 1 year of the polymer-free Cre8 DES vs. nonpolymer-free DES for the percutaneous treatment of CTO. Methods: Between September 2011 and August 2016, patients were prospectively enrolled in three CTO centres. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE), including cardiac death, any myocardial infarction, stent thrombosis, TVF and target vessel revascularization. Results: A total of 102 Cre8 and 133 non-Cre8 patients were enrolled. At 1 year, a low cumulative MACCE was observed in the Cre8 group (6.9%, respectively). Moreover, a numerical trend towards better MACCE was observed in the Cre8 group vs. the non-Cre8 group (6.9 vs. 14.3%; P U 0.065). The clinically driven TVF rate was not statistically different between Cre8 and non-Cre8 patients (6.9 vs. 9.8%; P U 0.373). A borderline significant difference regarding mortality was observed in favour of Cre8 patients (0 vs. 3.8%; P U 0.049). Conclusion: Low rates of MACCE and TVF up to 1 year were observed in the Cre8 group, supportive of the use of polymer-free DES for lesions with high complexity.