Background: The number of patients with diabetes mellitus (DM) presenting with coronary artery disease is increasing and accounts for more than 30% of patients undergoing percutaneous coronary interventions (PCI). The biodegradable polymer drug-eluting stents were developed to improve vascular healing. We sought to determine the 1-year clinical follow-up in patients with DM treated with the thin strut biodegradable polymer-coated sirolimus-eluting (BP-SES) stent versus durable coating everolimus-elutingstent (DP-EES).
Methods: We analyzed patients with DM treated with either a BP-SES (ALEX™, Balton, Poland, n=670) or DP-EES (XIENCE™, Abbott, USA, n=884) with available 1-year clinical follow-up using propensity-score matching. Outcomes included target vessel revascularization (TVR) as efficacy outcome and all-causedeath, myocardial infarction, and definite/probable stent thrombosis as safety outcomes.
Results: After propensity score matching 527 patients treated with BP-SES and 527 patients treated with DP-EES were selected. Procedural and clinical characteristics were similar between both groups. In-hospital mortality was 3.23% in BP-SES vs. 2.09% in DP-EES group, p=0.25. One-year follow-up demonstrated comparable efficacy outcome TVR (BP-SES 6.64% vs. DP-EES 5.88% p=0.611), as well as similar safety outcomes of all-causedeath (BP-SES 10.06% vs. DP-EES 7.59% p=0.158), myocardial infarction (BP-SES 7.959% vs. 6.83%, p=0.813), anddefinite/probable stent thrombosis (BP-SES 1.14% vs. DP-EES 0.76%, p=0.525).
Conclusions: The thin-strutbiodegradable polymer coated sirolimus-eluting stent demonstrated comparable clinical outcomes at 1-year after implantation to the DP-EES. These data support the relative safety and efficacy of BP-SES in diabetic patients undergoing PCI.