Bioresorbable Polymer-Coated Thin Strut Sirolimus-Eluting Stent vs. Durable Polymer-Coated Everolimus-Eluting Stent in Daily Clinical Practice: Three-Year Follow-Up Data from Interventional Cardiology Network Registry

Aims: Presence of durable polymers may be associated with late/very late stent thrombosis occurrence and the need for prolonged dual antiplatelet therapy. Bioabsorbable polymers may facilitate stent healing, thus enhancing clinical safety. We sought to determine the 3-year clinical follow-up in patients treated with the thin strut (71um) bioabsorbable polymer-coated sirolimus-eluting stent (ALEX™, Balton, Poland) versus durable coating everolimus eluting stent (XIENCE™, Abbott, USA) in daily clinical routine.

Methods: Interventional Cardiology Network Registry is a multicenter, all-comers registry of 21.400 patients treated with PCI between 2010 and 2016. All patients who underwent implantation of either ALEX (n=287) or XIENCE (n=1114) stents within a time frame of availability of 3-year clinical follow-up were included. We evaluated the incidence of all-cause deaths at 3-year follow-up and a composite endpoint of death or myocardial infarction.

Results: Patients assigned for ALEX implantation more frequently presented with STEMI and had lower LVEF. There was also a statistical trend towards higher cardiogenic shock presence on admission in the ALEX group. There was no significant differences between the groups in procedure related complications and in-hospital mortality (ALEX:1.8% vs. XIENCE:1.0% p=0.22). Follow-up demonstrated similar 3-year all-cause mortality (ALEX:12.0% vs. XIENCE:11.9% p=0.99), as well as comparable incidence of composite endpoint in ALEX group when compared to XIENCE (19.9% vs. 20.0%, p=0.98, respectively).

Conclusions: ALEX stent demonstrated comparable clinical outcomes at 3 years after implantation to the XIENCE stent. These data support the relative long-term safety and efficacy of ALEX in a broad range of patients undergoing percutaneous coronary interventions.